Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL
Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Terminated
CT.gov ID
NCT01465334
Collaborator
National Comprehensive Cancer Network (Other), GlaxoSmithKline (Industry)
30
2
2
61
15
0.2
Study Details
Study Description
Brief Summary
The main purpose of this study is to examine how two separate groups of 17p deletion Chronic lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular combination of drugs. The two groups are those participants who have previously received treatment for their CLL and those who have not yet received any treatment. The combination of drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab and Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p CLL. We hope that by combining these drugs together in this study, they will have more benefit than each one alone and that the subjects' CLL will be significantly impacted.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy.
Part A: Ofatumumab + HDMP 2-4 cycles Part B: Ofatumumab + Alemtuzumab 1-6 cycles Part C:
Maintenance with Ofatumumab + Alemtuzumab up to 2 years
Between days 15-22 of Cycle 2 of Part A, participants are restaged. Participants who achieve nodal complete response discontinue Part A therapy and undergo minimal residual disease (MRD) assessment to guide the decision whether to go to Part B or Part C. The participants with persistent disease after 2 cycles of Part A therapy receive 2 more cycles of Part A therapy and then undergo another restaging as well as MRD assessment. At restaging, participants with minimal disease are eligible for Part C or allogeneic stem cell transplant (SCT) off protocol. The remaining participants receive Part B therapy. On Part B, restaging occurs at weeks 12 and 18. If MRD negative complete response (CR) status is achieved then therapy is discontinued and the primary endpoint evaluation occurs 2 months later. Otherwise with persistent disease Part B therapy continues up to 24 weeks and the primary endpoint evaluation occurs after Part B therapy is completed. Participants who achieve clinical complete response may receive Part C therapy or be observed while waiting SCT.
Study Design
Study Type:
Interventional
Actual Enrollment
:
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL
Study Start Date
:
Dec 1, 2011
Actual Primary Completion Date
:
Nov 1, 2014
Actual Study Completion Date
:
Jan 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Naive Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
Drug: Ofatumumab
Other Names:
Drug: High-Dose Methylprednisolone
Other Names:
Drug: Alemtuzumab
Other Names:
|
| Experimental: Relapsed/Refractory Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
Drug: Ofatumumab
Other Names:
Drug: High-Dose Methylprednisolone
Other Names:
Drug: Alemtuzumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Induction Overall Response Rate (ORR) [Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.]
Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter).
Secondary Outcome Measures
- Number of Participants Achieving Induction Complete Response (CR) [Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B.]
CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter.
- Overall Objective Response Rate (ORR) [Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.]
Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter).
- Number of Participants With Overall CR [Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.]
CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter.
- Overall MRD Negative Rate [MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C.]
Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes.
- Transplant Rate [Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C)]
Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT.
- Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction [Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks)]
Participants ever experiencing a grade 1-3 hyperglycemia event based on CTCAEv4 with treatment attribution of possible, probably or definite as reported on case report forms were counted.
- 3-Year Progression-Free Survival (PFS) Probability [Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years.]
3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology.
- 3-year Overall Survival (OS) Probability [Median survival follow-up was 45 months (range 31-58 months) in this study cohort.]
3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods.
- Number of Participants Completing Part A Treatment [Evaluated up to 4 cycles/16 weeks.]
Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol.
- Number of Participants Completing Only 2 Cycles of Part A Treatment [Evaluated after 2 cycles/8 weeks of Part A therapy.]
Participants counted if only completed 2 cycles of Part A treatment per protocol.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Documented CLL/SLL
-
17p deletion by FISH in 20% or more nuclei on peripheral blood, bone marrow or lymph node
-
Normal organ function
Exclusion Criteria:
-
Pregnant or breast feeding
-
Current active hepatic or biliary disease
-
Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, tuberculosis and active Hepatitis C
-
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
-
Other past or current malignancy. Participants who have been free of malignancy for at least 2 years, or who have a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
-
Known HIV positive
-
Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to study entry, congestive heart failure, and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
-
Significant concurrent uncontrolled medical conditions including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the subject.
-
Positive serology for Hepatitis B or C
-
History of allergic reactions attributed to ofatumumab.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 2 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- National Comprehensive Cancer Network
- GlaxoSmithKline
Investigators
- Principal Investigator: Jennifer R Brown, MD PhD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jennifer R. Brown, MD, PhD,
Principal Investigator,
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01465334
Other Study ID Numbers:
- 11-304
- NCCN Protocol Number: NCCN-001
- GSK Protocol Number: OFT115580
First Posted:
Nov 4, 2011
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Jennifer R. Brown, MD, PhD,
Principal Investigator,
Dana-Farber Cancer Institute
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants enrolled between December 2011 and November 2014. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Period Title: Overall Study | ||
| STARTED | 15 | 15 |
| Complete Part A Induction | 12 | 15 |
| Complete Part B Induction | 7 | 15 |
| Eligible for Allogeneic Transplant | 9 | 9 |
| COMPLETED | 13 | 9 |
| NOT COMPLETED | 2 | 6 |
Baseline Characteristics
| Arm/Group Title | Treatment Naive | Relapsed/Refractory | Total |
|---|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Total of all reporting groups |
| Overall Participants | 15 | 15 | 30 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
64
|
65
|
65
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
7
46.7%
|
3
20%
|
10
33.3%
|
| Male |
8
53.3%
|
12
80%
|
20
66.7%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
15
100%
|
15
100%
|
30
100%
|
| Number of Prior Therapies (Count of Participants) | |||
| 0 |
15
100%
|
0
0%
|
15
50%
|
| 1 |
0
0%
|
6
40%
|
6
20%
|
| 2 |
0
0%
|
4
26.7%
|
4
13.3%
|
| 3 |
0
0%
|
2
13.3%
|
2
6.7%
|
| 4 |
0
0%
|
3
20%
|
3
10%
|
| Time from Diagnosis to First Therapy (months) [Mean (Full Range) ] | |||
| Mean (Full Range) [months] |
6.9
|
23
|
12.4
|
| Time from Diagnosis to Start on Trial (months) [Mean (Full Range) ] | |||
| Mean (Full Range) [months] |
6.8
|
59.4
|
27.6
|
| Whole Exome Sequencing-Mutations (mutations) [Median (Full Range) ] | |||
| Median (Full Range) [mutations] |
22
|
20
|
21
|
| Whole Exome Sequencing-Copy Number Alterations (Events) [Median (Full Range) ] | |||
| Median (Full Range) [Events] |
12.5
|
14
|
14
|
Outcome Measures
| Title | Induction Overall Response Rate (ORR) |
|---|---|
| Description | Induction ORR is the percentage of participants achieving a minimum of partial response (PR) over induction treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). |
| Time Frame | Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number (90% Confidence Interval) [percentage of participants] |
73
486.7%
|
60
400%
|
| Title | Number of Participants Achieving Induction Complete Response (CR) |
|---|---|
| Description | CR over induction treatment was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. |
| Time Frame | Disease was evaluated after weeks 8 and 16 of Part A and at 12, 18 and 24 weeks during part B. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number [participants] |
0
0%
|
0
0%
|
| Title | Overall Objective Response Rate (ORR) |
|---|---|
| Description | Overall ORR is the percentage of participants achieving a minimum of partial response (PR) over induction and maintenance treatment based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. PR is a 50% or greater decrease of measured size of lymphadenopathy, hepatomegaly, splenomegaly as well as blood lymphocytes (over baseline), marrow infiltrate or B-lymphoid nodules and a 50% or greater increase from baseline in platelet count (or level >100,000/micro liter), hemoglobin (or level >11 grams/deciliter), neutrophils (or level >1500/microliter). |
| Time Frame | Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number (90% Confidence Interval) [percentage of participants] |
80
533.3%
|
67
446.7%
|
| Title | Number of Participants With Overall CR |
|---|---|
| Description | CR overall (induction and maintenance treatment) was based on International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008). There are numerous diagnostic tests used for response evaluation including potentially CBC and differential count, marrow aspirate and biopsy, ultrasound of the abdomen, CT scans (chest, pelvis, abdomen) and physical examination. CR is absence of significant lymphadenopathy (nodes<1.5 centimeters in long axis diameter), hepatomegaly, splenomegaly as well as blood lymphocytes<4000/microliter, normocellular for age marrow with <30% lymphocytes, no B-lymphoid nodules and platelet>100,000/micro liter, hemoglobin>11 grams/deciliter, neutrophils>1500/microliter. |
| Time Frame | Disease was evaluated after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number [participants] |
2
13.3%
|
0
0%
|
| Title | Overall MRD Negative Rate |
|---|---|
| Description | Overall MRD negative rate is the percentage of participants classified as MRD negative by four color flow cytometry. The assay has a sensitivity of 1 in 10,000 leukocytes. |
| Time Frame | MRD was assessed after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number (90% Confidence Interval) [percentage of participants] |
80
533.3%
|
53
353.3%
|
| Title | Transplant Rate |
|---|---|
| Description | Percentage of participants eligible for allogeneic hematopoietic stem cell transplantation (alloHSCT) that are able and willing to proceed to alloHSCT. |
| Time Frame | Evaluated up to 36 cycles (approximately 2.75 years) of treatment (Parts A, B and C) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number (90% Confidence Interval) [percentage of participants] |
43
286.7%
|
43
286.7%
|
| Title | Number of Participants With Treatment-Related Grades 1-3 Hyperglycemia During Part A Induction |
|---|---|
| Description | Participants ever experiencing a grade 1-3 hyperglycemia event based on CTCAEv4 with treatment attribution of possible, probably or definite as reported on case report forms were counted. |
| Time Frame | Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number [participants] |
5
33.3%
|
6
40%
|
| Title | 3-Year Progression-Free Survival (PFS) Probability |
|---|---|
| Description | 3-year PFS is the probability of participants remaining alive and progression-free at 3 years from study entry estimated using Kaplan-Meier methods. Disease progression (PD) per International Workshop on Chronic Lymphocytic Leukemia (IW-CLL) criteria (Hallek, et al 2008) is: the appearance of any new lesion (enlarged lymph node minimum >1.5 centimeters); an increase by 50% in greatest determined diameter of any previous site; an increase in the previously noted enlargement of the liver or spleen by 50% or more or the de novo appearance of hepatomegaly, splenomegaly; a 50% increase of blood lymphocytes (over baseline with level at least 5,000/microliter); occurrence of cytopenia secondary to CLL at least 3 months post treatment including a 50% or greater decrease from baseline in platelet count (or level <100,000/microliter) or a hemoglobin decrease of >2 grams/deciliter (or level <10 grams/deciliter); and transformation to a more aggressive histology. |
| Time Frame | Disease was evaluated on treatment after weeks 8 and 16 of Part A, at 12, 18 and 24 weeks during part B and every 6 months on Part C as well as off-treatment every 3 months up to 5 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number (95% Confidence Interval) [percentage probability] |
53
|
25
|
| Title | 3-year Overall Survival (OS) Probability |
|---|---|
| Description | 3-year OS is the probability of participants remaining alive at 3 years from study entry estimated using Kaplan-Meier methods. |
| Time Frame | Median survival follow-up was 45 months (range 31-58 months) in this study cohort. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number (95% Confidence Interval) [percentage probability] |
66
|
53
|
| Title | Number of Participants Completing Part A Treatment |
|---|---|
| Description | Participants counted as completing Part A with either 2 or 4 cycles of treatment per protocol. |
| Time Frame | Evaluated up to 4 cycles/16 weeks. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number [participants] |
12
80%
|
15
100%
|
| Title | Number of Participants Completing Only 2 Cycles of Part A Treatment |
|---|---|
| Description | Participants counted if only completed 2 cycles of Part A treatment per protocol. |
| Time Frame | Evaluated after 2 cycles/8 weeks of Part A therapy. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Treatment Naive | Relapsed/Refractory |
|---|---|---|
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy as follows (cycle duration=28 days): Induction Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: cycle 1 - 300 mg intravenously (IV) Day 1 then 1000 mg IV Days 8, 15, 22; cycles 2-4 - 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants with nodal complete response at cycle 2 re-staging then discontinued Part A therapy. Induction Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants with at least stable disease could continue continue to Part C or, if eligible, proceed to allogeneic stem cell transplant (SCT) off study. Maintenance Part C: Ofatumumab + Alemtuzumab up to 26 cycles Ofatumumab: 1000 mg IV Day 1 every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 |
| Measure Participants | 15 | 15 |
| Number [participants] |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse Events (AEs) were collected weekly during cycle 1 Part A and then every other week for the duration of Part A (up to 16 weeks); every cycle for the duration of Part B (up to 24 weeks); and every 56 days for the duration of Part C (up to 104 weeks). AEs in summary were collected up to 144 weeks of treatment plus 30 days. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment attribution of possibly, probably or definitely and grade 3 or higher. All remaining events regardless of treatment attribution were classified as Other AEs. Grades 1-2 AEs were not required reporting per protocol; all AEs collected were included in the calculation. No further data is available to specify classification of system organ class "Other" per CTCAEv4 criteria beyond the general term. | |||
| Arm/Group Title | Treatment Naive | Relapsed/Refractory | ||
| Arm/Group Description | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy. (cycle duration=28 days) Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B. Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B. Part C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | Participants were assigned to 1 of 2 groups based on prior treatment status. Both groups received the same therapy. (cycle duration=28 days) Part A: Ofatumumab + HDMP 2-4 cycles Ofatumumab: 1000 mg IV Days 1, 8, 15, 22 High-Dose Methylprednisolone (HDMP): 1000 mg/m2 IV Days 1-3 Participants who have not experienced a clinical complete response with no residual detectable disease after Part A will continue on to Part B. Part B: Ofatumumab + Alemtuzumab 1-6 cycles Ofatumumab: 1000 mg IV Day 1 Alemtuzumab: 30 mg subcutaneously Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26 Participants who have experienced at least stable disease in Parts A and B can continue on to Part C. Participants who are eligible may instead proceed to stem cell transplantation after Parts A and B. Part C: Maintenance with Ofatumumab + Alemtuzumab up to 2 years Ofatumumab: 1000 mg IV every other cycle Alemtuzumab: 30 mg subcutaneously Days 14, 28 | ||
All Cause Mortality |
||||
| Treatment Naive | Relapsed/Refractory | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/15 (46.7%) | 6/15 (40%) | ||
Serious Adverse Events |
||||
| Treatment Naive | Relapsed/Refractory | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/15 (73.3%) | 9/15 (60%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Febrile neutropenia | 3/15 (20%) | 1/15 (6.7%) | ||
| General disorders | ||||
| Infusion related reaction | 2/15 (13.3%) | 0/15 (0%) | ||
| Investigations | ||||
| Growth hormone abnormal | 1/15 (6.7%) | 0/15 (0%) | ||
| Lymphocyte count decreased | 1/15 (6.7%) | 2/15 (13.3%) | ||
| Lymphocyte count increased | 0/15 (0%) | 1/15 (6.7%) | ||
| Neutrophil count decreased | 6/15 (40%) | 7/15 (46.7%) | ||
| Platelet count decreased | 2/15 (13.3%) | 1/15 (6.7%) | ||
| White blood cell decreased | 4/15 (26.7%) | 5/15 (33.3%) | ||
| Metabolism and nutrition disorders | ||||
| Hyperglycemia | 3/15 (20%) | 3/15 (20%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 1/15 (6.7%) | 0/15 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Treatment related secondary malignancy | 1/15 (6.7%) | 0/15 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Pneumonitis | 0/15 (0%) | 1/15 (6.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Urticaria | 1/15 (6.7%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Treatment Naive | Relapsed/Refractory | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/15 (100%) | 14/15 (93.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 9/15 (60%) | 9/15 (60%) | ||
| Blood and lymphatic system disorders - Other | 0/15 (0%) | 2/15 (13.3%) | ||
| Febrile neutropenia | 0/15 (0%) | 1/15 (6.7%) | ||
| Cardiac disorders | ||||
| Acute coronary syndrome | 0/15 (0%) | 1/15 (6.7%) | ||
| Cardiac disorders - Other | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Chest pain - cardiac | 0/15 (0%) | 2/15 (13.3%) | ||
| Palpitations | 2/15 (13.3%) | 0/15 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear and labyrinth disorders - Other | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Ear and labyrinth disorders - Other, specify | 0/15 (0%) | 0/15 (0%) | ||
| Vertigo | 1/15 (6.7%) | 0/15 (0%) | ||
| Eye disorders | ||||
| Blurred vision | 2/15 (13.3%) | 0/15 (0%) | ||
| Dry eye | 1/15 (6.7%) | 0/15 (0%) | ||
| Eye disorders - Other | 2/15 (13.3%) | 0/15 (0%) | ||
| Flashing lights | 0/15 (0%) | 1/15 (6.7%) | ||
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/15 (13.3%) | 1/15 (6.7%) | ||
| Colonic ulcer | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Constipation | 3/15 (20%) | 3/15 (20%) | ||
| Diarrhea | 4/15 (26.7%) | 2/15 (13.3%) | ||
| Dry mouth | 1/15 (6.7%) | 0/15 (0%) | ||
| Duodenal hemorrhage | 0/15 (0%) | 2/15 (13.3%) | ||
| Flatulence | 0/15 (0%) | 1/15 (6.7%) | ||
| Gastritis | 0/15 (0%) | 1/15 (6.7%) | ||
| Gastroesophageal reflux disease | 2/15 (13.3%) | 0/15 (0%) | ||
| Gastrointestinal disorders - Other | 2/15 (13.3%) | 2/15 (13.3%) | ||
| Nausea | 5/15 (33.3%) | 0/15 (0%) | ||
| Nausea | 0/15 (0%) | 6/15 (40%) | ||
| Oral pain | 0/15 (0%) | 1/15 (6.7%) | ||
| Vomiting | 2/15 (13.3%) | 3/15 (20%) | ||
| General disorders | ||||
| Chills | 4/15 (26.7%) | 1/15 (6.7%) | ||
| Edema face | 2/15 (13.3%) | 0/15 (0%) | ||
| Edema limbs | 4/15 (26.7%) | 3/15 (20%) | ||
| Edema trunk | 1/15 (6.7%) | 0/15 (0%) | ||
| Fatigue | 10/15 (66.7%) | 9/15 (60%) | ||
| Fever | 10/15 (66.7%) | 7/15 (46.7%) | ||
| General disorders and administration site conditions - Other | 1/15 (6.7%) | 3/15 (20%) | ||
| Infusion related reaction | 3/15 (20%) | 1/15 (6.7%) | ||
| Injection site reaction | 1/15 (6.7%) | 0/15 (0%) | ||
| Irritability | 1/15 (6.7%) | 0/15 (0%) | ||
| Localized edema | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Malaise | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Pain | 4/15 (26.7%) | 1/15 (6.7%) | ||
| Immune system disorders | ||||
| Allergic reaction | 2/15 (13.3%) | 0/15 (0%) | ||
| Infections and infestations | ||||
| Infections and infestations - Other | 2/15 (13.3%) | 0/15 (0%) | ||
| Laryngitis | 0/15 (0%) | 1/15 (6.7%) | ||
| Papulopustular rash | 1/15 (6.7%) | 0/15 (0%) | ||
| Sinusitis | 1/15 (6.7%) | 0/15 (0%) | ||
| Skin infection | 0/15 (0%) | 2/15 (13.3%) | ||
| Upper respiratory infection | 1/15 (6.7%) | 2/15 (13.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Bruising | 1/15 (6.7%) | 0/15 (0%) | ||
| Fracture | 1/15 (6.7%) | 0/15 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 6/15 (40%) | 3/15 (20%) | ||
| Alkaline phosphatase increased | 4/15 (26.7%) | 2/15 (13.3%) | ||
| Aspartate aminotransferase increased | 9/15 (60%) | 4/15 (26.7%) | ||
| Blood bilirubin increased | 2/15 (13.3%) | 2/15 (13.3%) | ||
| Creatinine increased | 2/15 (13.3%) | 3/15 (20%) | ||
| Investigations - Other | 1/15 (6.7%) | 0/15 (0%) | ||
| Neutrophil count decreased | 7/15 (46.7%) | 8/15 (53.3%) | ||
| Platelet count decreased | 4/15 (26.7%) | 8/15 (53.3%) | ||
| Weight gain | 1/15 (6.7%) | 0/15 (0%) | ||
| White blood cell decreased | 5/15 (33.3%) | 8/15 (53.3%) | ||
| Metabolism and nutrition disorders | ||||
| Anorexia | 2/15 (13.3%) | 1/15 (6.7%) | ||
| Dehydration | 0/15 (0%) | 2/15 (13.3%) | ||
| Hyperglycemia | 6/15 (40%) | 6/15 (40%) | ||
| Hyperkalemia | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Hypermagnesemia | 1/15 (6.7%) | 0/15 (0%) | ||
| Hypernatremia | 1/15 (6.7%) | 0/15 (0%) | ||
| Hyperuricemia | 1/15 (6.7%) | 2/15 (13.3%) | ||
| Hypoalbuminemia | 0/15 (0%) | 1/15 (6.7%) | ||
| Hypocalcemia | 7/15 (46.7%) | 4/15 (26.7%) | ||
| Hypoglycemia | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Hypokalemia | 1/15 (6.7%) | 0/15 (0%) | ||
| Hypokalemia | 0/15 (0%) | 2/15 (13.3%) | ||
| Hypomagnesemia | 0/15 (0%) | 2/15 (13.3%) | ||
| Hyponatremia | 2/15 (13.3%) | 4/15 (26.7%) | ||
| Hypophosphatemia | 3/15 (20%) | 2/15 (13.3%) | ||
| Metabolism and nutrition disorders - Other | 2/15 (13.3%) | 0/15 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthritis | 1/15 (6.7%) | 0/15 (0%) | ||
| Back pain | 1/15 (6.7%) | 2/15 (13.3%) | ||
| Bone pain | 2/15 (13.3%) | 1/15 (6.7%) | ||
| Chest wall pain | 0/15 (0%) | 1/15 (6.7%) | ||
| Generalized muscle weakness | 0/15 (0%) | 1/15 (6.7%) | ||
| Muscle weakness lower limb | 0/15 (0%) | 2/15 (13.3%) | ||
| Musculoskeletal and connective tissue disorder - Other | 2/15 (13.3%) | 3/15 (20%) | ||
| Myalgia | 2/15 (13.3%) | 0/15 (0%) | ||
| Neck pain | 1/15 (6.7%) | 0/15 (0%) | ||
| Pain in extremity | 1/15 (6.7%) | 0/15 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 1/15 (6.7%) | 0/15 (0%) | ||
| Headache | 4/15 (26.7%) | 3/15 (20%) | ||
| Myelitis | 0/15 (0%) | 1/15 (6.7%) | ||
| Nervous system disorders - Other | 3/15 (20%) | 3/15 (20%) | ||
| Paresthesia | 1/15 (6.7%) | 0/15 (0%) | ||
| Peripheral motor neuropathy | 1/15 (6.7%) | 2/15 (13.3%) | ||
| Peripheral sensory neuropathy | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Somnolence | 1/15 (6.7%) | 0/15 (0%) | ||
| Syncope | 0/15 (0%) | 1/15 (6.7%) | ||
| Tremor | 0/15 (0%) | 1/15 (6.7%) | ||
| Psychiatric disorders | ||||
| Anxiety | 4/15 (26.7%) | 3/15 (20%) | ||
| Confusion | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Depression | 1/15 (6.7%) | 0/15 (0%) | ||
| Insomnia | 3/15 (20%) | 4/15 (26.7%) | ||
| Restlessness | 1/15 (6.7%) | 0/15 (0%) | ||
| Renal and urinary disorders | ||||
| Renal and urinary disorders - Other | 1/15 (6.7%) | 0/15 (0%) | ||
| Urinary frequency | 4/15 (26.7%) | 2/15 (13.3%) | ||
| Urinary retention | 1/15 (6.7%) | 0/15 (0%) | ||
| Reproductive system and breast disorders | ||||
| Pelvic pain | 2/15 (13.3%) | 1/15 (6.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 6/15 (40%) | 7/15 (46.7%) | ||
| Dyspnea | 5/15 (33.3%) | 6/15 (40%) | ||
| Epistaxis | 0/15 (0%) | 1/15 (6.7%) | ||
| Laryngeal inflammation | 1/15 (6.7%) | 0/15 (0%) | ||
| Nasal congestion | 3/15 (20%) | 2/15 (13.3%) | ||
| Pleural effusion | 1/15 (6.7%) | 0/15 (0%) | ||
| Pneumonitis | 2/15 (13.3%) | 1/15 (6.7%) | ||
| Postnasal drip | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Respiratory failure | 0/15 (0%) | 1/15 (6.7%) | ||
| Respiratory, thoracic and mediastinal disorders - Other | 3/15 (20%) | 2/15 (13.3%) | ||
| Sore throat | 1/15 (6.7%) | 0/15 (0%) | ||
| Wheezing | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 1/15 (6.7%) | 1/15 (6.7%) | ||
| Bullous dermatitis | 2/15 (13.3%) | 0/15 (0%) | ||
| Dry skin | 1/15 (6.7%) | 0/15 (0%) | ||
| Erythema multiforme | 2/15 (13.3%) | 0/15 (0%) | ||
| Hyperhidrosis | 4/15 (26.7%) | 2/15 (13.3%) | ||
| Lipohypertrophy | 1/15 (6.7%) | 0/15 (0%) | ||
| Photosensitivity | 1/15 (6.7%) | 0/15 (0%) | ||
| Pruritus | 3/15 (20%) | 0/15 (0%) | ||
| Rash acneiform | 1/15 (6.7%) | 0/15 (0%) | ||
| Rash maculo-papular | 3/15 (20%) | 0/15 (0%) | ||
| Skin and subcutaneous tissue disorders - Other | 5/15 (33.3%) | 3/15 (20%) | ||
| Urticaria | 2/15 (13.3%) | 0/15 (0%) | ||
| Vascular disorders | ||||
| Flushing | 0/15 (0%) | 1/15 (6.7%) | ||
| Hematoma | 0/15 (0%) | 1/15 (6.7%) | ||
| Hypertension | 1/15 (6.7%) | 0/15 (0%) | ||
| Superficial thrombophlebitis | 1/15 (6.7%) | 0/15 (0%) | ||
| Thromboembolic event | 1/15 (6.7%) | 0/15 (0%) | ||
| Vascular disorders - Other | 0/15 (0%) | 1/15 (6.7%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jennifer R. Brown, MD, PhD |
|---|---|
| Organization | Dana-Farber Cancer Institute |
| Phone | (617) 632-3316 |
| Jennifer_Brown@dfci.harvard.edu |
Responsible Party:
Jennifer R. Brown, MD, PhD,
Principal Investigator,
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01465334
Other Study ID Numbers:
- 11-304
- NCCN Protocol Number: NCCN-001
- GSK Protocol Number: OFT115580
First Posted:
Nov 4, 2011
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022