Safety Study of CAT-8015 to Treat Advanced B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (NHL or CLL)

• Sponsor: MedImmune LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01030536
• Collaborator: (none)
• Enrollment: 23
• Locations: 8
• Arms: 5
• Actual Duration (Months): 36.6
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The primary objectives of this study are to determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) and safety profile of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], mantle cell lymphoma [MCL]) or CLL.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma; Chronic Lymphocytic Leukemia	Drug: CAT-8015 20 mcg/kg; Drug: CAT-8015 30 mcg/kg; Drug: CAT-8015 40 mcg/kg; Drug: CAT-8015 50 mcg/kg; Drug: CAT-8015 60 mcg/kg	Phase 1/Phase 2

Detailed Description

To determine the maximum tolerated dose (MTD) or optimal biologic dose (OBD) of CAT-8015 in participants with relapsed or refractory advanced B-cell NHL (DLBCL, FL, MCL) or CLL.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Study of CAT-8015 in Adult Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
• Actual Study Start Date: Feb 15, 2010
• Actual Primary Completion Date: Mar 4, 2013
• Actual Study Completion Date: Mar 4, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAT-8015 20 microgram per kilogram (mcg/kg) Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation is to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level are possible if an MTD or OBD is not reached by 60 mcg/kg.	Drug: CAT-8015 20 mcg/kg; Participants will receive 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
Experimental: CAT-8015 30 mcg/kg Participants will receive 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation is to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level are possible if an MTD or OBD is not reached by 60 mcg/kg.	Drug: CAT-8015 30 mcg/kg; Participants will receive 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
Experimental: CAT-8015 40 mcg/kg Participants will receive 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation is to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level are possible if an MTD or OBD is not reached by 60 mcg/kg.	Drug: CAT-8015 40 mcg/kg; Participants will receive 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
Experimental: CAT-8015 50 mcg/kg Participants will receive 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation is to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level are possible if an MTD or OBD is not reached by 60 mcg/kg.	Drug: CAT-8015 50 mcg/kg; Participants will receive 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.
Experimental: CAT-8015 60 mcg/kg Participants will receive 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation is to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level are possible if an MTD or OBD is not reached by 60 mcg/kg.	Drug: CAT-8015 60 mcg/kg; Participants will receive 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle.

Outcome Measures

Primary Outcome Measures

1. Maximum Tolerated Dose (MTD) [Day 1 to end of Cycle 1 (approximately 28 days)]

   MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity [DLT]) in more than 30 percent (%) of participants.

2. Number of Participants With Dose Limiting Toxicities (DLTs) [Day 1 to end of Cycle 1 (approximately 28 days)]

   Any Grade 3 or greater, non-hematological toxicity (including capillary leak syndrome [CLS] and thrombotic microangiopathy/ hemolytic uremic syndrome (HUS), Grade 3 or higher treatment-related hematologic toxicities and only ≥ Grade 3 thrombotic microangiopathy /HUS constituted a DLT with few exceptions.

3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [From Screening (Day -28) to Post Therapy Day 30]

   Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

4. Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Post Therapy Day 30]

   Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

5. Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Post Therapy Day 30]

   Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

6. Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Post Therapy Day 30]

   Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.

Secondary Outcome Measures

1. Percentage of Participants With Complete Response (CR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

   The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy.

2. Duration of Complete Response [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

   Duration of CR was measured from the first documentation of a CR to the time of relapse for the subgroup of participants with CR. Duration of CR was calculated using the Kaplan Meier method. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

3. Percentage of Participants With Partial Response (PR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

4. Percentage of Participants With Objective Response (OR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

   OR was defined as the percentage of participants with CR or partial response (PR).

5. Time to Response (TTR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

   TTR was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was only assessed in participants who had achieved objective response (OR).

6. Duration of Objective Response (DOR) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

   DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method.

7. Duration of Stable Disease (SD) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

   Duration of SD was defined as the time period from start of moxetumomab pasudotox administration to the event of progressive disease (PD)/relapse. Duration of SD was only calculated for the subgroup of participants with best response of CR, PR, or SD, and was calculated using the Kaplan-Meier method.

8. Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox [Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle]

   Maximum observed drug concentration of Moxetumomab pasudotox in plasma.

9. Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox [Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle]

   Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma.

10. Clearance (CL) of Moxetumomab Pasudotox [Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle]

    CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed.

11. Elimination Half Life (t1/2) of Moxetumomab Pasudotox [Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle]

    Plasma decay half life is the time measured for the plasma concentration to decrease by one half.

12. Number of Participants With Positive Anti-Drug Antibody [Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)]

    The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA).

13. Number of Participants With CD22 Expression Levels [Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)]

    CD22 Expression was analyzed using Prism® analysis. Flow cytometry was performed to quantitate the CD22 expression for the purpose of evaluating the relationship of CD22 expression with response to treatment.

14. Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs) [From Screening (Day -28) to Post Therapy Day 30]

    The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined.

15. Percentage of Participants With Stable Disease (SD) [Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

• Participants must have histologically confirmed B-cell CLL, including small lymphocytic lymphoma (SLL), DLBCL, MCL, or FL

• B-cell NHL: a) Have previous confirmation of B-cell NHL b) Participants with DLBCL or MCL, must have relapsed or refractory disease after at least one prior regimen containing rituximab, either alone or in combination, and be ineligible for any available standard line of therapy known to be life-prolonging or life-saving c) Participants with FL, must have relapsed or refractory disease after at least two prior regimens, one of which included rituximab, either alone or in combination, and be ineligible for any available standard line of therapy known to be life-prolonging or life-saving d) Have measurable disease (at least one lesion greater than or equal to (≥) 20 millimeter (mm) in one dimension or ≥ 15 mm in two dimensions as measured by conventional or high resolution [spiral] computed tomography e) Not be a candidate for a hematopoietic stem cell (HSC) or bone marrow transplant

• B-cell CLL: a) Have previous confirmation of B-cell CLL with a characteristic immunophenotype by flow cytometry b) Have relapsed or refractory disease after at least 2 prior lines of treatment, at least 1 of which must have contained rituximab and be ineligible for any available standard line of therapy known to be life-prolonging or life-saving c) Not be a candidate for an HSC or BM transplant d) Have symptomatic disease that requires treatment

• Karnofsky Performance Status ≥ 70

• Life expectancy of ≥ 12 weeks

• Toxicities from previous cancer therapies must have recovered to Grade less than (<) 2

• Adequate hematological function defined as: a) Hemoglobin ≥ 9 g/dL b) Absolute neutrophil count ≥ 1500/mm^{3 c) Platelet count ≥ 75,000/mm}3

• Prothrombin time-International Normalized Ratio/Partial thromboplastin time less than or equal to (≤) 1.5 × upper limit of normal (ULN), or for participants on anticoagulation therapy, status within therapeutic range

• Women of non-child-bearing potential or using effective contraception

• Male participants with partners of child-bearing potential must be surgically sterile or use a contraceptive method

Exclusion Criteria:

• Any available standard line of therapy known to be life-prolonging or life-saving

• Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for treatment of cancer

• For CLL participants only, rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy

• History of allergy or reaction to any component of the CAT-8015

• Receipt of any chemotherapy or small molecule targeted therapy or any biological- or immunological-based therapies for leukemia or lymphoma within 6 weeks

• Prior radiation therapy will not be excluded, providing the volume of bone marrow treated is less than 25 percent

• Any history of prior pseudomonas-exotoxin immunotoxin administration including CAT-8015, CAT-3888, or LMB-2

• History of other invasive malignancy within 5 years, with some exceptions

• Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic or antiviral therapy or for which other supportive care is given

• Autologous stem cell transplantation within 6 months prior to study entry

• Allogenic stem cell transplantation or any other organ transplant

• HIV-positive or AIDS, Hepatitis B or hepatitis C infection as defined by seropositive for hepatitis B (HBsAg) or hepatitis C and elevated liver transaminases

• Use of immunosuppressive medication other than steroids within 7 days, use of systemic steroids within 7 days before the first dose of CAT-8015 (inhaled and topical corticosteroids are permitted). Participants may take replacement doses of steroids (defined as ≤ 30 mg/day hydrocortisone or the equivalent) if on a stable dose for at least 2 weeks prior to the first dose of CAT-8015

• Documented current central nervous system involvement by leukemia or lymphoma

• Pregnancy or lactation, other severe, concurrent diseases

• Concurrent enrollment in another clinical study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Los Angeles	California	United States
2	Research Site	Indianapolis	Indiana	United States	46202
3	Research Site	Bethesda	Maryland	United States	20892
4	Research Site	Las Vegas	Nevada	United States	89169
5	Research Site	Charleston	South Carolina	United States	29424
6	Research Site	Nashville	Tennessee	United States	37203
7	Research Site	Temple	Texas	United States	76508
8	Research Site	Łódź		Poland	93-510

Sponsors and Collaborators

• MedImmune LLC

Investigators

• Study Director: Ramy Ibrahim, M.D., MedImmune LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedImmune LLC
• ClinicalTrials.gov Identifier: NCT01030536
• Other Study ID Numbers: MI-CP218; NCT01086644
• First Posted: Dec 11, 2009
• Last Update Posted: Apr 9, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by MedImmune LLC: NHL; CLL
• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Immunotoxin HA22

Study Results

Participant Flow

Recruitment Details	Study was started on 15 Feb 2010 and was terminated on 12 Sep 2012. The Product Development Team authorized early termination of this study due to prioritization of resources and the need to prioritize allocation of investigational product across the studies in the moxetumomab pasudotox clinical development program.
Pre-assignment Detail	A total of 30 participants were screened and enrolled, of them 7 were failed screening. Twenty three participants were enrolled and assigned to treatment at 6 sites in the United States.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Period Title: Overall Study
STARTED	7	6	6	3	1
COMPLETED	0	0	0	0	0
NOT COMPLETED	7	6	6	3	1

Baseline Characteristics

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)	Total
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Total of all reporting groups
Overall Participants	7	6	6	3	1	23
Age (years) [Mean (Standard Deviation) ]
Age	63.4 (8.7)	53.7 (16.9)	63.5 (10.0)	52.3 (14.6)	66.0 (NA)	59.6 (12.4)
Sex: Female, Male (Count of Participants)
Female	2 28.6%	1 16.7%	0 0%	0 0%	1 100%	4 17.4%
Male	5 71.4%	5 83.3%	6 100%	3 100%	0 0%	19 82.6%

Outcome Measures

1. Primary Outcome

Title	Maximum Tolerated Dose (MTD)
Description	MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity [DLT]) in more than 30 percent (%) of participants.
Time Frame	Day 1 to end of Cycle 1 (approximately 28 days)

Outcome Measure Data

Analysis Population Description

Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Number [mcg/Kg]	NA	NA	NA	NA	NA

2. Primary Outcome

Title	Number of Participants With Dose Limiting Toxicities (DLTs)
Description	Any Grade 3 or greater, non-hematological toxicity (including capillary leak syndrome [CLS] and thrombotic microangiopathy/ hemolytic uremic syndrome (HUS), Grade 3 or higher treatment-related hematologic toxicities and only ≥ Grade 3 thrombotic microangiopathy /HUS constituted a DLT with few exceptions.
Time Frame	Day 1 to end of Cycle 1 (approximately 28 days)

Outcome Measure Data

Analysis Population Description

Evaluable Population for DLT included all participants enrolled in the dose-escalation phase who received at least one full cycle of moxetumomab pasudotox and completed safety follow-up through the DLT evaluation period or experienced any DLT.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Count of Participants [Participants]	0 0%	2 33.3%	1 16.7%	0 0%	1 100%

3. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Description	Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An Serious Adverse Event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Time Frame	From Screening (Day -28) to Post Therapy Day 30

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
TEAEs	7 100%	6 100%	6 100%	3 100%	1 100%
TESAEs	0 0%	3 50%	2 33.3%	0 0%	1 100%

4. Primary Outcome

Title	Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Description	Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Time Frame	From Screening (Day -28) to Post Therapy Day 30

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Anaemia	0 0%	3 50%	3 50%	0 0%	1 100%
Neutrophil count decreased	1 14.3%	0 0%	0 0%	1 33.3%	1 100%
Neutropenia	1 14.3%	1 16.7%	0 0%	0 0%	0 0%
Platelet count decreased	0 0%	0 0%	1 16.7%	0 0%	1 100%
Thrombocytopenia	0 0%	2 33.3%	0 0%	0 0%	0 0%
Leukocytosis	0 0%	1 16.7%	0 0%	0 0%	0 0%
Hypoalbuminaemia	2 28.6%	1 16.7%	2 33.3%	0 0%	1 100%
Hypertriglyceridaemia	0 0%	3 50%	0 0%	1 33.3%	1 100%
Hyponatraemia	0 0%	1 16.7%	3 50%	0 0%	1 100%
Alanine aminotransferase increased	1 14.3%	1 16.7%	0 0%	1 33.3%	1 100%
Blood creatinine increased	1 14.3%	2 33.3%	0 0%	0 0%	1 100%
Hypernatraemia	2 28.6%	0 0%	1 16.7%	0 0%	1 100%
Hypocalcaemia	0 0%	1 16.7%	2 33.3%	0 0%	1 100%
Aspartate aminotransferase increased	1 14.3%	1 16.7%	0 0%	1 33.3%	0 0%
Hypokalaemia	0 0%	0 0%	1 16.7%	1 33.3%	1 100%
Blood alkaline phosphatase increased	0 0%	0 0%	0 0%	1 33.3%	1 100%
Hypercalcaemia	0 0%	1 16.7%	0 0%	0 0%	1 100%
Hyperglycaemia	0 0%	1 16.7%	1 16.7%	0 0%	0 0%
Hyperkalaemia	0 0%	1 16.7%	1 16.7%	0 0%	0 0%
Hyperuricaemia	1 14.3%	0 0%	0 0%	0 0%	1 100%
Hypophosphataemia	0 0%	0 0%	1 16.7%	1 33.3%	0 0%
Blood albumin decreased	1 14.3%	0 0%	0 0%	0 0%	0 0%
Blood bicarbonate increased	0 0%	0 0%	0 0%	0 0%	1 100%
Blood bilirubin increased	1 14.3%	0 0%	0 0%	0 0%	0 0%
Blood triglycerides increased	0 0%	1 16.7%	0 0%	0 0%	0 0%
Haptoglobin decreased	0 0%	0 0%	0 0%	0 0%	1 100%
Hyperchlorhydria	0 0%	0 0%	1 16.7%	0 0%	0 0%
Hyperlipidaemia	0 0%	0 0%	1 16.7%	0 0%	0 0%
Hypermagnesaemia	0 0%	0 0%	0 0%	0 0%	1 100%
Hematuria	0 0%	1 16.7%	1 16.7%	0 0%	1 100%

5. Primary Outcome

Title	Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Description	Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Time Frame	From Screening (Day -28) to Post Therapy Day 30

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Hypotension	1 14.3%	1 16.7%	1 16.7%	0 0%	1 100%
Hypertension	0 0%	2 33.3%	1 16.7%	0 0%	0 0%
Pyrexia	0 0%	1 16.7%	1 16.7%	0 0%	0 0%
Weight Increased	1 14.3%	0 0%	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)
Description	Treatment-emergent adverse event (TEAEs) were defined as events that occur following the first injection of study treatment, or that started prior to the first injection and worsened during treatment. An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events were defined as adverse events/serious adverse events that started or worsened after the study drug treatment.
Time Frame	From Screening (Day -28) to Post Therapy Day 30

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Sinus Tachycardia	0 0%	1 16.7%	0 0%	0 0%	0 0%
ECG QT Prolonged	2 28.6%	0 0%	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Percentage of Participants With Complete Response (CR)
Description	The CR rate was defined as the percentage of participants who had achieved CR based on both the evaluable population for efficacy.
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Number [Percentage of Participants]	0 0%	0 0%	0 0%	0 0%

8. Secondary Outcome

Title	Duration of Complete Response
Description	Duration of CR was measured from the first documentation of a CR to the time of relapse for the subgroup of participants with CR. Duration of CR was calculated using the Kaplan Meier method. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Median (Full Range) [Months]	NA	NA	NA	NA

9. Secondary Outcome

Title	Percentage of Participants With Partial Response (PR)
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Number [Percentage of Participants]	10 142.9%	0 0%	0 0%	0 0%

10. Secondary Outcome

Title	Percentage of Participants With Objective Response (OR)
Description	OR was defined as the percentage of participants with CR or partial response (PR).
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Number [Percentage of Participants]	10 142.9%	0 0%	0 0%	0 0%

11. Secondary Outcome

Title	Time to Response (TTR)
Description	TTR was measured from the start of moxetumomab pasudotox administration to the first documentation of response (CR or PR) and was only assessed in participants who had achieved objective response (OR).
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Median (Full Range) [Months]	0.79	NA	NA	NA

12. Secondary Outcome

Title	Duration of Objective Response (DOR)
Description	DOR was measured from the first documentation of OR to the event of relapse. DOR was calculated using the Kaplan-Meier method.
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Median (Full Range) [Months]	7.66	NA	NA	NA

13. Secondary Outcome

Title	Duration of Stable Disease (SD)
Description	Duration of SD was defined as the time period from start of moxetumomab pasudotox administration to the event of progressive disease (PD)/relapse. Duration of SD was only calculated for the subgroup of participants with best response of CR, PR, or SD, and was calculated using the Kaplan-Meier method.
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Median (Full Range) [Months]	1.87	NA	0.95	4.67

14. Secondary Outcome

Title	Maximum Plasma Concentration (Cmax) of Moxetumomab Pasudotox
Description	Maximum observed drug concentration of Moxetumomab pasudotox in plasma.
Time Frame	Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	6	6	6	3	1
Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]	283 (159)	452 (141)	589 (366)	769 (221)	818 (NA)

15. Secondary Outcome

Title	Area Under Concentration-Time Curve From Dosing Extrapolated to Infinity (AUCinf) of Moxetumomab Pasudotox
Description	Area under the concentration versus time curve from zero to infinity (AUC) of Moxetumomab pasudotox in Plasma.
Time Frame	Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	5	5	5	3	1
Mean (Standard Deviation) [hour*nanogram per milliliter (hr*ng/mL)]	1120 (928)	1640 (682)	2050 (1150)	2320 (1010)	1810 (NA)

16. Secondary Outcome

Title	Clearance (CL) of Moxetumomab Pasudotox
Description	CL of drug is rate at which drug is metabolized or eliminated by normal biological processes and is influenced by fraction of dose absorbed.
Time Frame	Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	5	5	5	3	1
Mean (Standard Deviation) [milliliter per hour per kilogram]	31.6 (25.5)	22.2 (12.5)	26.9 (18.6)	25.2 (12.9)	33.1 (NA)

17. Secondary Outcome

Title	Elimination Half Life (t1/2) of Moxetumomab Pasudotox
Description	Plasma decay half life is the time measured for the plasma concentration to decrease by one half.
Time Frame	Pre-dose and End of infusion on Day 1, 3 and 5 of each cycle; 1, 3 and 6 hour after the end of infusion on Day 1 of each cycle

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	5	5	5	3	1
Mean (Standard Deviation) [hour]	1.55 (1.10)	1.87 (0.985)	1.68 (0.726)	1.87 (0.586)	0.901 (NA)

18. Secondary Outcome

Title	Number of Participants With Positive Anti-Drug Antibody
Description	The moxetumomab pasudotox specific bridging assay using the Meso Scale Discovery platform was employed to detect anti-drug antibodies (ADA).
Time Frame	Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Count of Participants [Participants]	5 71.4%	4 66.7%	5 83.3%	2 66.7%	0 0%

19. Secondary Outcome

Title	Number of Participants With CD22 Expression Levels
Description	CD22 Expression was analyzed using Prism® analysis. Flow cytometry was performed to quantitate the CD22 expression for the purpose of evaluating the relationship of CD22 expression with response to treatment.
Time Frame	Baseline (Day 1) up to End of the Treatment (Last dose of Last cycle) (approximately 3 years)

Outcome Measure Data

Analysis Population Description

Evaluable population for expression of CD22 on malignant cells included all participants with peripheral blood samples containing 10 or more B cells (CD19-positive cells) per cubic millimeter.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	7	2	4
Count of Participants [Participants]	8 114.3%	5 83.3%	2 33.3%	1 33.3%

20. Secondary Outcome

Title	Number of Capillary Leak Syndrome (CLS) Participants With Weight Changes, Albumin, Hypotension, Edema, Hypoxia, and Pulmonary Adverse Events (AEs)
Description	The correlation of CLS and weight changes, albumin, hypotension, edema, hypoxia, and pulmonary AEs were examined.
Time Frame	From Screening (Day -28) to Post Therapy Day 30

Outcome Measure Data

Analysis Population Description

Safety Population included all participants who received moxetumomab pasudotox. The safety population was used to evaluate baseline characteristics as well as all endpoints for safety.

Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)	CAT-8015 30 Microgram Per Kilogram (mcg/kg)	CAT-8015 40 Microgram Per Kilogram (mcg/kg)	CAT-8015 50 Microgram Per Kilogram (mcg/kg)	CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.	Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
Measure Participants	7	6	6	3	1
Count of Participants [Participants]	1 14.3%	0 0%	1 16.7%	0 0%	0 0%

21. Secondary Outcome

Title	Percentage of Participants With Stable Disease (SD)
Time Frame	Baseline (Day 1) until Final Study Visit Post Therapy (up to 2 year after the last participant begins study drug treatment)

Outcome Measure Data

Analysis Population Description

Evaluable Population for efficacy included all participants who received any moxetumomab pasudotox treatment and completed at least one post-baseline disease assessment. The Evaluable Population for efficacy was used to evaluate the endpoints for the efficacy profile.

Arm/Group Title	Chronic Lymphocytic Leukemia	Diffuse Large B Cell Lymphoma	Mantle Cell Lymphoma	Follicular Lymphoma
Arm/Group Description	Participants with Chronic Lymphocytic Leukemia were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Diffuse Large B cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Mantle Cell Lymphoma were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.	Participants with Follicular Lymphoma (FL) were included. Moxetumomab pasudotox was administered at doses of 20, 30, 40, 50, or 60 mcg/kg on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60mcg/kg.
Measure Participants	10	6	1	3
Number [Percentage of Participants]	40.0 571.4%	0.0 0%	100.0 1666.7%	66.7 2223.3%

Adverse Events

Time Frame	From Screening (Day -28) to Post Therapy Day 30
Arm/Group Title	CAT-8015 20 Microgram Per Kilogram (mcg/kg)		CAT-8015 30 Microgram Per Kilogram (mcg/kg)		CAT-8015 40 Microgram Per Kilogram (mcg/kg)		CAT-8015 50 Microgram Per Kilogram (mcg/kg)		CAT-8015 60 Microgram Per Kilogram (mcg/kg)
Arm/Group Description	Participants received 20 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.		Participants received 30 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.		Participants received 40 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.		Participants received 50 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.		Participants received 60 mcg/kg Moxetumomab pasudotox (CAT-8015) as an intravenous (IV) infusion over 30 minutes on Days 1, 3, and 5 of every 28-day cycle. Dose escalation was to be continued to the Maximum tolerated dose (MTD) or Optimal biologic dose (OBD). Subsequent dose levels with a 10 mcg/kg increase from the previous dose level were possible if an MTD or OBD was not reached by 60 mcg/kg.
All Cause Mortality
	CAT-8015 20 Microgram Per Kilogram (mcg/kg)		CAT-8015 30 Microgram Per Kilogram (mcg/kg)		CAT-8015 40 Microgram Per Kilogram (mcg/kg)		CAT-8015 50 Microgram Per Kilogram (mcg/kg)		CAT-8015 60 Microgram Per Kilogram (mcg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	CAT-8015 20 Microgram Per Kilogram (mcg/kg)		CAT-8015 30 Microgram Per Kilogram (mcg/kg)		CAT-8015 40 Microgram Per Kilogram (mcg/kg)		CAT-8015 50 Microgram Per Kilogram (mcg/kg)		CAT-8015 60 Microgram Per Kilogram (mcg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		3/6 (50%)		2/6 (33.3%)		0/3 (0%)		1/1 (100%)
Infections and infestations
Lung infection	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Investigations
Blood creatinine increased	0/7 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma	0/7 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Tumour associated fever	0/7 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Renal and urinary disorders
Renal failure acute	0/7 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	0/7 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Vascular disorders
Capillary leak syndrome	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Other (Not Including Serious) Adverse Events
	CAT-8015 20 Microgram Per Kilogram (mcg/kg)		CAT-8015 30 Microgram Per Kilogram (mcg/kg)		CAT-8015 40 Microgram Per Kilogram (mcg/kg)		CAT-8015 50 Microgram Per Kilogram (mcg/kg)		CAT-8015 60 Microgram Per Kilogram (mcg/kg)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/7 (100%)		6/6 (100%)		6/6 (100%)		3/3 (100%)		1/1 (100%)
Blood and lymphatic system disorders
Anaemia	0/7 (0%)	0	3/6 (50%)	6	3/6 (50%)	4	0/3 (0%)	0	1/1 (100%)	1
Neutropenia	1/7 (14.3%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Thrombocytopenia	0/7 (0%)	0	2/6 (33.3%)	5	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Eye disorders
Vision blurred	1/7 (14.3%)	1	0/6 (0%)	0	0/6 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Gastrointestinal disorders
Abdominal pain	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	2	1/3 (33.3%)	1	0/1 (0%)	0
Constipation	0/7 (0%)	0	1/6 (16.7%)	1	2/6 (33.3%)	2	1/3 (33.3%)	1	1/1 (100%)	1
Diarrhoea	1/7 (14.3%)	1	0/6 (0%)	0	3/6 (50%)	4	0/3 (0%)	0	0/1 (0%)	0
Dyspepsia	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/3 (33.3%)	1	0/1 (0%)	0
Flatulence	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Nausea	2/7 (28.6%)	2	0/6 (0%)	0	2/6 (33.3%)	3	2/3 (66.7%)	2	0/1 (0%)	0
Vomiting	0/7 (0%)	0	1/6 (16.7%)	1	2/6 (33.3%)	3	1/3 (33.3%)	1	0/1 (0%)	0
General disorders
Chills	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Face oedema	2/7 (28.6%)	2	1/6 (16.7%)	1	0/6 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1
Fatigue	5/7 (71.4%)	6	0/6 (0%)	0	4/6 (66.7%)	4	0/3 (0%)	0	0/1 (0%)	0
Oedema peripheral	4/7 (57.1%)	5	1/6 (16.7%)	1	3/6 (50%)	11	2/3 (66.7%)	3	1/1 (100%)	1
Pain	0/7 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Pyrexia	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	2	0/3 (0%)	0	0/1 (0%)	0
Infections and infestations
Urinary tract infection	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	2	0/3 (0%)	0	0/1 (0%)	0
Investigations
Alanine aminotransferase increased	1/7 (14.3%)	1	1/6 (16.7%)	1	0/6 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1
Aspartate aminotransferase increased	1/7 (14.3%)	1	1/6 (16.7%)	1	0/6 (0%)	0	1/3 (33.3%)	1	0/1 (0%)	0
Blood alkaline phosphatase increased	0/7 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1
Blood creatinine increased	1/7 (14.3%)	1	2/6 (33.3%)	8	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Electrocardiogram qt prolonged	2/7 (28.6%)	2	0/6 (0%)	0	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Neutrophil count decreased	1/7 (14.3%)	1	0/6 (0%)	0	0/6 (0%)	0	1/3 (33.3%)	1	1/1 (100%)	1
Platelet count decreased	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/3 (0%)	0	1/1 (100%)	1
Metabolism and nutrition disorders
Decreased appetite	2/7 (28.6%)	2	0/6 (0%)	0	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Hypercalcaemia	0/7 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Hyperglycaemia	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Hyperkalaemia	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Hypernatraemia	2/7 (28.6%)	2	0/6 (0%)	0	1/6 (16.7%)	1	0/3 (0%)	0	1/1 (100%)	1
Hypertriglyceridaemia	0/7 (0%)	0	3/6 (50%)	9	0/6 (0%)	0	1/3 (33.3%)	2	1/1 (100%)	1
Hyperuricaemia	1/7 (14.3%)	1	0/6 (0%)	0	0/6 (0%)	0	0/3 (0%)	0	1/1 (100%)	1
Hypoalbuminaemia	2/7 (28.6%)	2	1/6 (16.7%)	1	2/6 (33.3%)	2	0/3 (0%)	0	1/1 (100%)	1
Hypocalcaemia	0/7 (0%)	0	1/6 (16.7%)	1	2/6 (33.3%)	3	0/3 (0%)	0	1/1 (100%)	1
Hypokalaemia	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/3 (33.3%)	1	1/1 (100%)	1
Hyponatraemia	0/7 (0%)	0	1/6 (16.7%)	1	3/6 (50%)	3	0/3 (0%)	0	1/1 (100%)	1
Hypophosphataemia	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	2	1/3 (33.3%)	1	0/1 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	1/7 (14.3%)	1	2/6 (33.3%)	2	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Musculoskeletal chest pain	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	1/3 (33.3%)	1	0/1 (0%)	0
Myalgia	1/7 (14.3%)	1	0/6 (0%)	0	1/6 (16.7%)	1	1/3 (33.3%)	1	0/1 (0%)	0
Pain in extremity	0/7 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/3 (33.3%)	1	0/1 (0%)	0
Nervous system disorders
Dizziness	1/7 (14.3%)	1	1/6 (16.7%)	1	2/6 (33.3%)	2	1/3 (33.3%)	1	0/1 (0%)	0
Headache	1/7 (14.3%)	1	2/6 (33.3%)	4	1/6 (16.7%)	1	2/3 (66.7%)	2	1/1 (100%)	1
Psychiatric disorders
Insomnia	0/7 (0%)	0	2/6 (33.3%)	3	0/6 (0%)	0	0/3 (0%)	0	0/1 (0%)	0
Renal and urinary disorders
Haematuria	0/7 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	5	0/3 (0%)	0	1/1 (100%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/7 (14.3%)	1	0/6 (0%)	0	3/6 (50%)	4	0/3 (0%)	0	0/1 (0%)	0
Dyspnoea	0/7 (0%)	0	1/6 (16.7%)	1	2/6 (33.3%)	2	1/3 (33.3%)	1	0/1 (0%)	0
Vascular disorders
Capillary leak syndrome	1/7 (14.3%)	1	0/6 (0%)	0	1/6 (16.7%)	3	0/3 (0%)	0	0/1 (0%)	0
Haematoma	1/7 (14.3%)	1	0/6 (0%)	0	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Hypertension	0/7 (0%)	0	2/6 (33.3%)	2	1/6 (16.7%)	1	0/3 (0%)	0	0/1 (0%)	0
Hypotension	1/7 (14.3%)	1	1/6 (16.7%)	1	1/6 (16.7%)	7	0/3 (0%)	0	1/1 (100%)	1

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.