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RAMO-2: A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma

Sponsor
Archigen Biotech Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT02809053
Collaborator
(none)
315
Enrollment
25
Locations
2
Arms
35.7
Actual Duration (Months)
12.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: SAIT101
  • Biological: MabThera®
 Phase 3

Detailed Description

This is a Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the statistical equivalence of efficacy, safety and immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in asymptomatic patients with Low Tumor Burden Follicular Lymphoma. Patients will be randomized in a 1:1 ratio to receive study drug once a week for 4 weeks, and will then be followed up for up to 52 weeks after the first dose. Randomization will be stratified by inclusion in the PK/PD sub-population and Follicular lymphoma international prognostic index 2 (FLIPI-2) score.

Visits are scheduled at Weeks 1, 2, 3, and 4 (study drug infusion visits), and then at Weeks 5, 12, 20, 28, 36, and 52 (i.e., End of Study [EOS]). Efficacy response assessments will be performed at Weeks 12 and 28, while safety assessments will continue until end of Study (EOS).

The primary objectives is to compare the efficacy of SAIT101 with rituximab licensed in the European Union (hereafter designated MabThera®, brand name in EU) when administered as a first-line immunotherapy in patients with low tumor burden follicular lymphoma (LTBFL) and the secondary objectives is to evaluate SAIT101 versus MabThera® with respect to safety and tolerability, immunogenicity and Pharmacokinetics (PK)/Pharmacodynamics (PD) in a sub-population of patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
315 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma
Actual Study Start Date :
Jan 18, 2017
Actual Primary Completion Date :
Jul 17, 2019
Actual Study Completion Date :
Jan 10, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: SAIT101

Biological: SAIT101
Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
Active Comparator: MabThera®

Biological: MabThera®
Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
Other Names:
  • Rituximab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) at Week 28 [Baseline (Day 0) to Week 28.]

      Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) at Week 12 [Baseline (Day 0) to Week 12]

      Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Tumour assessments were assessed by central imaging review per the International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.

    2. Complete Response (CR) at Weeks 12 and 28 [Baseline (Day 0) to Week 12 and Week 28.]

      Efficacy Endpoint: Complete Response (CR) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.

    3. Partial Response (PR) at Weeks 12 and 28 [Baseline (Day 0) to Week 12 and Week 28.]

      Efficacy Endpoint: Partial Response (PR) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.

    4. Stable Disease (SD) at Weeks 12 and 28 [Baseline (Day 0) to Week 12 and Week 28.]

      Efficacy endpoint: number of participants with Stable Disease (SD) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.

    5. Progressive Disease (PD) at 12 and 28 Weeks [Baseline (Week 0)to Week 12 and Week 28.]

      Efficacy endpoint: number of participants with Progressive Disease (PD) at 12 and 28 Weeks. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.

    6. Time to Event (TTE) [Baseline (Day 0) to time of event or up to a maximum of 32 weeks, whichever is sooner]

      Time to Event (TTE) is defined as the time of randomisation to the date when an event occurred for a maximum follow-up period of 32 weeks from baseline; an event is disease progression, death due to any cause, or the start of new treatment for follicular lymphoma, whichever comes first.

    Other Outcome Measures

    1. Truncated Area Under the Concentration-time Curve (AUC) Over the First and Fourth Dosing Intervals (AUC0 168,w1, AUC0-168,w4). [Baseline (Day 0) to dosing on Week 1 and Week 4]

      Pharmacokinetic endpoint: truncated area under the concentration-time curve (AUC) over the first (Day 1) and fourth (Day 22) dosing intervals (AUC0 168,w1, AUC0-168,w4).

    2. Maximum Concentration (Cmax) After the First Dose and the Fourth Dose (Cmax,w1, Cmax,w4). [Baseline (Day 0) to dosing on Week 1 and Week 4]

      Pharmacokinetic endpoint: maximum plasma concentration (Cmax, µg/ml ) after the first dose (Week 1) and the fourth dose (week 4) (Cmax,w1, Cmax,w4).

    3. Accumulation Ratio for AUC0-168 Obtained From the Fourth Dose Versus the First Dose (RAUC). [Baseline (Day 0) to dosing on Week 1 and Week 4]

      Pharmacokinetic endpoint: accumulation ratio for the Area Under the Concentration Time Cure 0 to 168 hours (AUC0-168) obtained from the fourth dose (Week 4) versus the first dose (Week 1) (RAUC). Accumulation ratio, calculated for AUC0-168 as (AUC0 168,w4/AUC0 168,w1).

    4. Accumulation Ratio for the Maximum Plasma Concentration (Cmax) From the Fourth Dose Versus the First Dose (RCmax). [Baseline (Day 0) to dosing on Week 1 and Week 4]

      Pharmacokinetic endpoint: accumulation ratio for maximum plasma (Cmax) ratio from the fourth dose on Week 4 versus the first dose of treatment on Week 1 (RCmax). Accumulation ratio, calculated for Cmax as (Cmax,w4/Cmax,w1).

    5. Trough Concentrations on Days 1, 8, 15, 22, and 29 (Ctrough). [Baseline (Day 0) to Days 1, 8, 15, 22 and 29]

      Pharmacokinetic endpoint: trough plasma concentration (Ctrough) during the dosing phase on Days 1, 8, 15, 22, and 29. Concentrations at predose on Days 8, 15, and 22 (µg/mL) and the time equivalent to the predose on Day 29, obtained directly from the observed concentration versus time data.

    6. Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28 [Baseline (Day 1) to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.]

      Pharmacodynamic Endpoint: Arithmetic mean observed change from baseline of B-lymphocyte antigen cluster of differentiation 19 (CD-19+ B-cell) counts (cells/μL) up to Week 28 by treatment.

    7. Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28 [Baseline (Day 1) to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.]

      Pharmacodynamic Endpoint: percent change from baseline of B-lymphocyte antigen cluster of differentiation 19 (CD-19+ B-cell) counts (cells/μL) up to Week 28 by treatment.

    8. Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval [Baseline (Day 0) to Week 1, 2, 3, 4 12 and 28.]

      Pharmacodynamic Endpoint: Area under the change from baseline CD19+ B-cell count time curve (AUEC) over the first dosing interval on week 1 from time 0 to the time prior to the second dose (AUEC0 168,w1), AUEC over the second dosing interval on week 2 from time 0 to the time prior to the third dose (AUEC0-168,w2), AUEC over the third dosing interval on week 3 from time 0 to the time prior to the fourth dose (AUEC0-168,w3), AUEC over the fourth dosing interval on week 4 from time 0 to 168 hours post dose (AUEC0-168,w4), AUEC from time 0 on week 1 to the time point on week 12 (AUEC0-w12), AUEC from time 0 on week 1 to the time point on week 28 (AUEC0 w28) for the change from baseline CD19+ B-cell count data.

    9. Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval [Baseline (Day 0) to Week 1, 2, 3, 4 12 and 28.]

      Pharmacodynamic Endpoint: Area under the change from baseline CD19+ B-cell count time curve (AUEC) over the first dosing interval on week 1 from time 0 to the time prior to the second dose (AUEC0 168,w1), AUEC over the second dosing interval on week 2 from time 0 to the time prior to the third dose (AUEC0-168,w2), AUEC over the third dosing interval on week 3 from time 0 to the time prior to the fourth dose (AUEC0-168,w3), AUEC over the fourth dosing interval on week 4 from time 0 to 168 hours post dose (AUEC0-168,w4), AUEC from time 0 on week 1 to the time point on week 12 (AUEC0-w12), AUEC from time 0 on week 1 to the time point on week 28 (AUEC0 w28) for the change from baseline CD19+ B-cell count data. The time-normalized AUEC parameters presented were calculated by dividing the respective AUEC by the time interval used to calculate the AUEC.

    10. Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit [Pre-dose on Day 1 to Weeks 5, 12, 20 and 28.]

      Immunogenicity endpoint: incidence of antidrug antibodies (ADA) and Neutralising Antibody (NAb). Immunogenicity sampling was performed pre-dose at Day 1, weeks 2, 3 and 4 and at any time during the visits at weeks 5, 12, 20 and 28.

    11. Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time [Baseline to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.]

      Exploratory pharmacodynamic endpoint: Mean (SD) Change from Baseline of Immunoglobulin (IgG) and immunoglobulin M (IgM) (mg/dL) by Scheduled Time for Each Treatment (Safety Analysis Set). Samples for IgG and IgM assessment were collected at Baseline and Weeks 1, 2, 3, 4, 5, 12, 20 and 28.

    12. Exploratory Analyses of Tumor Response and Time to Event [Baseline (Day 0) to Week 28]

      Exploratory Efficacy Endpoint: Analyses of Tumor Response and Time to Event, as Determined by the Combined International Working Group (IWG) Criteria 2014, Lugano Classification and IWG Criteria 2007 (Central Assessment) (Full Analysis Set)

    13. Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28. [Baseline (Day 0) to Week 28]

      Exploratory Efficacy Endpoint: Overall Response Rate (ORR) at Week 28 by Region, Age, Gender and Anti-Drug antibody (ADA) status. ADA status through Week 28 is 'Positive' if 'Positive' at any time point, and 'Negative' if 'Negative' at all time points. The 95% CI (confidence interval) for overall response rate (ORR) was calculated using the Exact method. The results presented in this table are based on the non-responder imputed data.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with histologically-confirmed Low Tumor Burden Follicular Lymphoma, without B symptoms, Ann Arbor stage II to Non-Hodgkin's Lymphoma (NHL) (CD20+ Follicular Lymphoma of Grades 1, 2, or 3a)

    2. Low tumor burden according to The Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria defined as:

    • Normal serum lactate dehydrogenase (LDH)

    • No mass ≥7 cm.

    • Less than 3 nodal sites, each with diameter >3 cm

    • No systemic or B symptoms (fever >38°C for 3 consecutive days; recurrent, drenching night sweats; unintentional weight loss exceeding 10% body weight in the last 6 months.

    • No splenomegaly ≥16 cm by CT scan.

    • No risk of vital organ compression.

    • No pleural or peritoneal serous effusion.

    • No leukemic phase >5,000/µL circulating tumor cells.

    • No cytopenias (defined as platelets <100,000/mm3, hemoglobin <10 g/dL, or absolute neutrophil count <1,500/mm3).

    1. Patients not previously treated for their FL, including any previous treatment for FL under clinical trials except localized radiation therapy for previous limited stage disease.
    Exclusion Criteria:

    1. Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody.

    2. Prior radiotherapy completed <28 days before study enrollment.

    3. Anticipated need for concomitant administration of any other experimental drug, or a concomitant chemotherapy, anticancer hormonal therapy, radiotherapy, or immunotherapy during study participation.

    4. Concomitant disease which requires continuous therapy with corticosteroids at doses equivalent to prednisolone >20 mg/day.

    5. Transformation to high-grade lymphoma secondary to previously untreated low-grade lymphoma.

    6. Prior or concomitant malignancies within 5 years prior to screening, with the exceptions of non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, adequately treated breast cancer in situ, and localized prostate cancer stage T1c, provided that the patient underwent curative treatment and remains relapse free.

    7. Patients with a body surface area >3.0 m2.

    8. Major surgery (excluding lymph node biopsy) within 28 days prior to randomization.

    9. Primary or secondary immunodeficiency (history of, or currently active), including known history of human immunodeficiency virus (HIV) infection or positive test at screening.

    10. Acute, severe infection (e.g., sepsis and opportunistic infections), or active, chronic or persistent infection that might worsen with immunosuppressive treatment (e.g., herpes zoster).

    11. Positive serological test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C serology.

    12. Confirmed current active tuberculosis (TB)

    13. Central nervous system (CNS) or meningeal involvement, or cord compression by the lymphoma; history of CNS lymphoma

    14. History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the trial drug (e.g., hypersensitivity or allergy to murine products).

    15. Patients who have significant cardiac disease, including but not limited to history of congestive heart failure (New York Heart Association Class III/IV; see Appendix 7), unstable angina, or uncontrolled cardiac arrhythmia.

    16. Uncontrolled or severe hypertension, or cerebrovascular disease.

    17. Serious underlying medical conditions that, per the Investigator's discretion, could impair the ability of the patient to participate in the trial

    18. Any other co-existing medical or psychological condition(s) that will preclude participation in the study or compromise ability to give informed consent and/or comply with study procedures.

    19. Treatment with any investigational medicinal product (IMP) within 4 weeks prior to initiation of 1st infusion of study drug, or treatment with a drug that has not received regulatory approval for any indication within 4 weeks or a minimum of 5 half-lives, whichever is longer, of the 1st infusion of study drug.

    20. Receipt of a live/attenuated vaccine within 6 weeks prior to the screening visit.

    21. Females who are pregnant, breastfeeding, or planning a pregnancy during the treatment period or within 12 months after the last infusion of study drug.

    22. Patients who are investigational site staff members directly involved in the conduct of the trial, and their family members, site staff members otherwise supervised by the investigator, or patients who are Archigen employees directly involved in the conduct of the trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research site Whittier California United States 90603
    2 Research Site Canberra Australian Capital Territory Australia 2605
    3 Research site Temuco Araucania Chile 4810469
    4 Research site Hradec Kralove Czechia 500 05
    5 Research site Praha Czechia 128 08
    6 Reasearch site Praha Czechia 15000
    7 Research site Libourne Cedex Gironde France 33505
    8 Research site Poitiers Vienne France 86021
    9 Research site Hamburg Germany 22081
    10 Research site Budapest Hungary 1083
    11 Research site San Giovanni Rotondo Foggia Italy 71013
    12 Research site Terni Italy 05100
    13 Research site Busan Korea, Republic of 49241
    14 Research site Seoul Korea, Republic of 01757
    15 Research site Seoul Korea, Republic of 03080
    16 Research site Mexico City Distrito Federal Mexico 03720
    17 Research site Pretoria Gauteng South Africa 0181
    18 Research site L'Hospitalet de Llobregat Barcelona Spain 08907
    19 Research site Cádiz Spain 11009
    20 Research site Madrid Spain 28040
    21 Research site Ankara Turkey 06340
    22 Research site Istanbul Turkey 34098
    23 Research site Mersin Turkey 33343
    24 Research site Samsun Turkey 55139
    25 Research site Norwich Norfolk United Kingdom NR4 7UY

    Sponsors and Collaborators

    • Archigen Biotech Limited

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Archigen Biotech Limited
    ClinicalTrials.gov Identifier:
    NCT02809053
    Other Study ID Numbers:
    • AGB002
    First Posted:
    Jun 22, 2016
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Archigen Biotech Limited
    low tumor burden follicular lymphoma (LTBFL)
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular
    Rituximab

    Study Results

    Participant Flow

    Recruitment Details One hundred and one study centres in 29 countries participated in the study. The first participant was enrolled into the study on the 18 January 2017 and the last participant completed week 28 (primary analysis cut-off) on the 17 July 2019.
    Pre-assignment Detail A total of 455 participants were consented for the study and 315 participants were randomized in a 1:1 ration to receive SAIT101 (n=157) versus MabThera (n=158).
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Period Title: Overall Study
    STARTED 157 158
    Completed Treatment 156 156
    COMPLETED 150 152
    NOT COMPLETED 7 6

    Baseline Characteristics

    Arm/Group Title SAIT101 MabThera Total
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4. MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4. Total of all reporting groups
    Overall Participants 157 158 315
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.8
    (12.38)
    58.4
    (12.78)
    58.1
    (12.57)
    Sex: Female, Male (Count of Participants)
    Female
    86
    54.8%
    88
    55.7%
    174
    55.2%
    Male
    71
    45.2%
    70
    44.3%
    141
    44.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    11
    7%
    7
    4.4%
    18
    5.7%
    Not Hispanic or Latino
    136
    86.6%
    139
    88%
    275
    87.3%
    Unknown or Not Reported
    10
    6.4%
    12
    7.6%
    22
    7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.6%
    1
    0.6%
    2
    0.6%
    Asian
    31
    19.7%
    30
    19%
    61
    19.4%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    0.6%
    1
    0.6%
    2
    0.6%
    White
    115
    73.2%
    111
    70.3%
    226
    71.7%
    More than one race
    1
    0.6%
    2
    1.3%
    3
    1%
    Unknown or Not Reported
    8
    5.1%
    13
    8.2%
    21
    6.7%
    Region of Enrollment (participants) [Number]
    Hungary
    4
    2.5%
    9
    5.7%
    13
    4.1%
    Czechia
    26
    16.6%
    24
    15.2%
    50
    15.9%
    United States
    2
    1.3%
    3
    1.9%
    5
    1.6%
    United Kingdom
    3
    1.9%
    1
    0.6%
    4
    1.3%
    Spain
    18
    11.5%
    22
    13.9%
    40
    12.7%
    South Korea
    10
    6.4%
    12
    7.6%
    22
    7%
    Turkey
    9
    5.7%
    9
    5.7%
    18
    5.7%
    Italy
    13
    8.3%
    8
    5.1%
    21
    6.7%
    Mexico
    1
    0.6%
    1
    0.6%
    2
    0.6%
    South Africa
    6
    3.8%
    2
    1.3%
    8
    2.5%
    Australia
    3
    1.9%
    5
    3.2%
    8
    2.5%
    Chile
    2
    1.3%
    1
    0.6%
    3
    1%
    France
    7
    4.5%
    8
    5.1%
    15
    4.8%
    Germany
    5
    3.2%
    4
    2.5%
    9
    2.9%
    Ukraine
    5
    3.2%
    8
    5.1%
    13
    4.1%
    Thailand
    3
    1.9%
    1
    0.6%
    4
    1.3%
    Serbia
    1
    0.6%
    3
    1.9%
    4
    1.3%
    Panama
    1
    0.6%
    0
    0%
    1
    0.3%
    India
    16
    10.2%
    16
    10.1%
    32
    10.2%
    Georgia
    2
    1.3%
    2
    1.3%
    4
    1.3%
    Guatemala
    2
    1.3%
    3
    1.9%
    5
    1.6%
    Belarus
    10
    6.4%
    5
    3.2%
    15
    4.8%
    Croatia
    0
    0%
    2
    1.3%
    2
    0.6%
    Egypt
    7
    4.5%
    8
    5.1%
    15
    4.8%
    Philippines
    1
    0.6%
    1
    0.6%
    2
    0.6%
    Height (cm) (cm) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [cm]
    165.96
    (9.436)
    165.71
    (10.650)
    165.84
    (10.048)
    Weight at baseline (kg) (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    73.80
    (15.107)
    73.54
    (16.602)
    73.67
    (15.850)
    Body Mass Index (kg/m^2) (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    26.76
    (4.857)
    26.66
    (4.967)
    26.71
    (4.905)
    Body Surface Area (m^2) (m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [m^2]
    1.812
    (0.2032)
    1.807
    (0.2332)
    1.810
    (0.2184)
    Disease Duration (Years) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    0.937
    (2.1528)
    0.934
    (2.5793)
    0.935
    (2.3726)
    Females of childbearing potential (Count of Participants)
    Count of Participants [Participants]
    24
    15.3%
    20
    12.7%
    44
    14%
    Eastern Co-operative Oncology Group (ECOG) performance status (Count of Participants)
    ECOG Score 0
    132
    84.1%
    118
    74.7%
    250
    79.4%
    ECOG Score 1
    25
    15.9%
    40
    25.3%
    65
    20.6%
    Antidrug Antibody (ADA) Status at Baseline (Count of Participants)
    Positive
    3
    1.9%
    2
    1.3%
    5
    1.6%
    Negative
    138
    87.9%
    148
    93.7%
    286
    90.8%
    Not available
    16
    10.2%
    8
    5.1%
    24
    7.6%
    Ann Arbor Staging (Count of Participants)
    Stage I
    1
    0.6%
    0
    0%
    1
    0.3%
    Stage II
    39
    24.8%
    37
    23.4%
    76
    24.1%
    Stage III
    72
    45.9%
    69
    43.7%
    141
    44.8%
    Stage IV
    45
    28.7%
    52
    32.9%
    97
    30.8%
    Type of Ann Arbor Staging (Count of Participants)
    Clinical Stage (CS)
    144
    91.7%
    140
    88.6%
    284
    90.2%
    Pathological Stage (PS)
    13
    8.3%
    18
    11.4%
    31
    9.8%
    Risk Groups According to Follicular Lymphoma International Prognostic Index (FLIP-2) Score (Count of Participants)
    Low Risk (0 to 1 risk factors)
    102
    65%
    103
    65.2%
    205
    65.1%
    Intermediate Risk (2 risk factors)
    40
    25.5%
    41
    25.9%
    81
    25.7%
    High Risk (Greater than or equal to 3 risk factor
    15
    9.6%
    14
    8.9%
    29
    9.2%

    Outcome Measures

    1. Primary Outcome
    Title Overall Response Rate (ORR) at Week 28
    Description Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) at Week 28, as defined by International Working Group (IWG) criteria 2007. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
    Time Frame Baseline (Day 0) to Week 28.

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    Number (95% Confidence Interval) [percentage of participants]
    66.3
    42.2%
    70.6
    44.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Adjusted Difference Rate (%) in Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 28.
    Type of Statistical Test Other
    Comments The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Adjusted Difference Rate (%)
    Estimated Value -4.2
    Confidence Interval (2-Sided) 95%
    -14.80 to 6.35
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.40
    Estimation Comments Comparison: SAIT101 versus MabThera.
    2. Secondary Outcome
    Title Overall Response Rate (ORR) at Week 12
    Description Overall Response Rate (ORR) = Complete Response (CR) + Partial Response (PR). Tumour assessments were assessed by central imaging review per the International Working Group (IWG) Criteria 2007. The 95% CI for overall response rate (ORR) was calculated using the Exact method and combined using the Rubin's rule when multiple imputation was applicable.
    Time Frame Baseline (Day 0) to Week 12

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    Number (95% Confidence Interval) [percentage of participants]
    59.6
    38%
    70.0
    44.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Adjusted Difference Rate of Overall Response Rate (ORR) of SAIT101 versus MabThera at Week 12.
    Type of Statistical Test Other
    Comments The 95%CI (confidence interval) for the difference in the overall response rate (ORR) was calculated using the Newcombe-Wilson method based on CMH (Cochran-Mantel-Haenszel) weight with stratification factor FLIPI-2 (low, intermediate and high risk).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Adjusted Difference Rate
    Estimated Value -10.3
    Confidence Interval (2-Sided) 95%
    -20.92 to 0.61
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.42
    Estimation Comments Comparison: SAIT101 versus MabThera
    3. Secondary Outcome
    Title Complete Response (CR) at Weeks 12 and 28
    Description Efficacy Endpoint: Complete Response (CR) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
    Time Frame Baseline (Day 0) to Week 12 and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    CR at Week 12
    39
    24.8%
    37
    23.4%
    CR at Week 28
    51
    32.5%
    50
    31.6%
    4. Secondary Outcome
    Title Partial Response (PR) at Weeks 12 and 28
    Description Efficacy Endpoint: Partial Response (PR) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
    Time Frame Baseline (Day 0) to Week 12 and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    PR at Week 12
    48
    30.6%
    68
    43%
    PR at Week 28
    47
    29.9%
    53
    33.5%
    5. Secondary Outcome
    Title Stable Disease (SD) at Weeks 12 and 28
    Description Efficacy endpoint: number of participants with Stable Disease (SD) at Weeks 12 and 28. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
    Time Frame Baseline (Day 0) to Week 12 and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    SD at Week 12
    50
    31.8%
    39
    24.7%
    SD at Week 28
    22
    14%
    27
    17.1%
    6. Secondary Outcome
    Title Progressive Disease (PD) at 12 and 28 Weeks
    Description Efficacy endpoint: number of participants with Progressive Disease (PD) at 12 and 28 Weeks. Tumour assessments were assessed by central imaging review per International Working Group (IWG) Criteria 2007.
    Time Frame Baseline (Week 0)to Week 12 and Week 28.

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Dataset (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    PD at Week 12
    4
    2.5%
    1
    0.6%
    PD at Week 28
    20
    12.7%
    11
    7%
    7. Secondary Outcome
    Title Time to Event (TTE)
    Description Time to Event (TTE) is defined as the time of randomisation to the date when an event occurred for a maximum follow-up period of 32 weeks from baseline; an event is disease progression, death due to any cause, or the start of new treatment for follicular lymphoma, whichever comes first.
    Time Frame Baseline (Day 0) to time of event or up to a maximum of 32 weeks, whichever is sooner

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    Mean (Standard Deviation) [Weeks]
    23.50
    (7.500)
    24.08
    (6.767)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Time to Event (TTE) Hazard Ratio (HR) of SAIT101:MabThera. The TTE is defined as the time from the date of randomization to the date when an event occurs; an event is disease progression as assessed by Investigator, death due to any cause, or the start of new treatment, whichever comes first.
    Type of Statistical Test Other
    Comments The estimated Hazard Ratio with 95% CI was obtained from Cox regression model; however, stratification factors, ie, FLIPI-2 (low, intermediate and high risk), were only taken into account if FLIPI-2 score=all.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.724
    Confidence Interval (2-Sided) 95%
    0.853 to 3.482
    Parameter Dispersion Type:
    Value:
    Estimation Comments Hazard Ration of TTE SAIT101:MabThera
    8. Other Pre-specified Outcome
    Title Truncated Area Under the Concentration-time Curve (AUC) Over the First and Fourth Dosing Intervals (AUC0 168,w1, AUC0-168,w4).
    Description Pharmacokinetic endpoint: truncated area under the concentration-time curve (AUC) over the first (Day 1) and fourth (Day 22) dosing intervals (AUC0 168,w1, AUC0-168,w4).
    Time Frame Baseline (Day 0) to dosing on Week 1 and Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic Analysis Set (PAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    AUC0-168, week 1
    20140
    (18.7)
    19860
    (18.3)
    AUC0-168, week 4
    41290
    (19.0)
    42600
    (19.4)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) (%) of SAIT101 versus MabThera Area Under the Concentration time Curve Day 0 to Week 1 (AUC0-168,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.
    Type of Statistical Test Equivalence
    Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GLS Mean Difference (%)
    Estimated Value 101.39
    Confidence Interval (2-Sided) 90%
    95.86 to 107.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera. Equivalence was demonstrated for SAIT101 and MabThera with exposure pharmacokinetic parameter AUC0-168,w1 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison: geometric least square (GLS) Mean Ratio (90% Confidence Interval (CI)) %) of SAIT101 versus MabThera Area Under the Concentration time Cure Day 0 to Week 4 (AUC0-168,w4) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.
    Type of Statistical Test Equivalence
    Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GLS Mean Difference (%)
    Estimated Value 96.92
    Confidence Interval (2-Sided) 90%
    90.85 to 103.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter AUC0-168,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).
    9. Other Pre-specified Outcome
    Title Maximum Concentration (Cmax) After the First Dose and the Fourth Dose (Cmax,w1, Cmax,w4).
    Description Pharmacokinetic endpoint: maximum plasma concentration (Cmax, µg/ml ) after the first dose (Week 1) and the fourth dose (week 4) (Cmax,w1, Cmax,w4).
    Time Frame Baseline (Day 0) to dosing on Week 1 and Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic Analysis Set (PAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    Cmax, week 1
    199.3
    (22.1)
    200.6
    (27.5)
    Cmax, week 4
    333.6
    (22.8)
    336.2
    (20.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 1 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment.
    Type of Statistical Test Equivalence
    Comments Standard acceptance limits for bioequivalence (80.00% to 125.00
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GLS Mean Ratio (%)
    Estimated Value 99.35
    Confidence Interval (2-Sided) 90%
    90.85 to 103.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with Cmax,w1 exposure within the standard acceptance limits for bioequivalence (80.00% to 125.00%).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera maximum plasma concentration at Week 4 (Cmax,w1) (h×µg/mL). The statistical comparison of the loge-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment
    Type of Statistical Test Equivalence
    Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GLS Mean Ration (%)
    Estimated Value 99.23
    Confidence Interval (2-Sided) 90%
    92.96 to 105.92
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Cmax,w4 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).
    10. Other Pre-specified Outcome
    Title Accumulation Ratio for AUC0-168 Obtained From the Fourth Dose Versus the First Dose (RAUC).
    Description Pharmacokinetic endpoint: accumulation ratio for the Area Under the Concentration Time Cure 0 to 168 hours (AUC0-168) obtained from the fourth dose (Week 4) versus the first dose (Week 1) (RAUC). Accumulation ratio, calculated for AUC0-168 as (AUC0 168,w4/AUC0 168,w1).
    Time Frame Baseline (Day 0) to dosing on Week 1 and Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic Analysis Set (PAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    Geometric Mean (Geometric Coefficient of Variation) [Ratio]
    2.075
    (17.2)
    2.137
    (21.0)
    11. Other Pre-specified Outcome
    Title Accumulation Ratio for the Maximum Plasma Concentration (Cmax) From the Fourth Dose Versus the First Dose (RCmax).
    Description Pharmacokinetic endpoint: accumulation ratio for maximum plasma (Cmax) ratio from the fourth dose on Week 4 versus the first dose of treatment on Week 1 (RCmax). Accumulation ratio, calculated for Cmax as (Cmax,w4/Cmax,w1).
    Time Frame Baseline (Day 0) to dosing on Week 1 and Week 4

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic Analysis set (PAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    Geometric Mean (Geometric Coefficient of Variation) [Ratio]
    1.706
    (23.2)
    1.671
    (21.0)
    12. Other Pre-specified Outcome
    Title Trough Concentrations on Days 1, 8, 15, 22, and 29 (Ctrough).
    Description Pharmacokinetic endpoint: trough plasma concentration (Ctrough) during the dosing phase on Days 1, 8, 15, 22, and 29. Concentrations at predose on Days 8, 15, and 22 (µg/mL) and the time equivalent to the predose on Day 29, obtained directly from the observed concentration versus time data.
    Time Frame Baseline (Day 0) to Days 1, 8, 15, 22 and 29

    Outcome Measure Data

    Analysis Population Description
    Pharmacokinetic Analysis Set (PAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    Ctrough Day 8
    60.60
    (45.5)
    61.00
    (43.4)
    Ctrough Day 15
    108.1
    (26.0)
    107.3
    (32.0)
    Ctrough Day 22
    143
    (23.8)
    143.3
    (30.0)
    Ctrough Day 29
    181.7
    (22.1)
    190.4
    (26.1)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison: geometric least square (GLS) Mean Ratio (90% CI) (%) of SAIT101 versus MabThera trough plasma concentration at the end of the dosing period (Day 29) (Ctrough,d29) (µg/mL) . The statistical comparison of the log-transformed primary parameters between treatments is based on an analysis of variance model with fixed effect for treatment
    Type of Statistical Test Equivalence
    Comments Standard acceptance limits for bioequivalence (80.00% to 125.00%).
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GLS Mean Ratio (%)
    Estimated Value 95.45
    Confidence Interval (2-Sided) 90%
    88.85 to 102.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera. Pharmacokinetic equivalence was demonstrated for SAIT101 and MabThera with exposure PK parameter Ctrough,d29 within the standard acceptance limits for bioequivalence (80.00% to 125.00%).
    13. Other Pre-specified Outcome
    Title Observed Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
    Description Pharmacodynamic Endpoint: Arithmetic mean observed change from baseline of B-lymphocyte antigen cluster of differentiation 19 (CD-19+ B-cell) counts (cells/μL) up to Week 28 by treatment.
    Time Frame Baseline (Day 1) to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic Analysis Set (PDS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    Week 1 Mean Change from Baseline
    -128.0
    (115.71)
    -141.6
    (120.90)
    Week 2 Mean Change from Baseline
    -144.1
    (123.34)
    -146.8
    (138.76)
    Week 3 Mean Change from Baseline
    -142.8
    (122.63)
    -157.4
    (102.03)
    Week 4 Mean Change from Baseline
    -141.5
    (122.92)
    -141.2
    (102.03)
    Week 5 Mean Change from Baseline
    -140.0
    (120.74)
    -158.5
    (134.27)
    Week 12 Mean Change from Baseline
    -144.2
    (122.09)
    -160.1
    (134.09)
    Week 20 Mean Change from Baseline
    -140.8
    (117.98)
    -159.5
    (135.63)
    Week 28 Mean Change from Baseline
    -136.6
    (122.80)
    -148.2
    (134.79)
    14. Other Pre-specified Outcome
    Title Percent Change From Baseline CD19+ B-Lymphocyte Cluster of Differentiation 19 (CD-19+ B-Cell) Counts up to Week 28
    Description Pharmacodynamic Endpoint: percent change from baseline of B-lymphocyte antigen cluster of differentiation 19 (CD-19+ B-cell) counts (cells/μL) up to Week 28 by treatment.
    Time Frame Baseline (Day 1) to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic Analysis Set (PDS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    Week 1 % Change from Baseline
    -89.02
    (26.324)
    -95.58
    (8.294)
    Week 2 % Change from Baseline
    -100.00
    (0.000)
    -94.62
    (1.230)
    Week 3 % Change from Baseline
    -100.00
    (0.000)
    -100.00
    (0.000)
    Week 4 % Change from Baseline
    -100.00
    (0.000)
    -100.00
    (0.000)
    Week 5 % Change from Baseline
    -100.00
    (0.000)
    -100.00
    (0.000)
    Week 12 % Change from Baseline
    -100.00
    (0.000)
    -100.00
    (0.000)
    Week 20 % Change from Baseline
    -100.00
    (0.000)
    -100.00
    (0.000)
    Week 28 % Change from Baseline
    -97.42
    (12.749)
    -100.00
    (0.000)
    15. Other Pre-specified Outcome
    Title Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
    Description Pharmacodynamic Endpoint: Area under the change from baseline CD19+ B-cell count time curve (AUEC) over the first dosing interval on week 1 from time 0 to the time prior to the second dose (AUEC0 168,w1), AUEC over the second dosing interval on week 2 from time 0 to the time prior to the third dose (AUEC0-168,w2), AUEC over the third dosing interval on week 3 from time 0 to the time prior to the fourth dose (AUEC0-168,w3), AUEC over the fourth dosing interval on week 4 from time 0 to 168 hours post dose (AUEC0-168,w4), AUEC from time 0 on week 1 to the time point on week 12 (AUEC0-w12), AUEC from time 0 on week 1 to the time point on week 28 (AUEC0 w28) for the change from baseline CD19+ B-cell count data.
    Time Frame Baseline (Day 0) to Week 1, 2, 3, 4 12 and 28.

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic Analysis Set
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    AUEC0-168,w1 (cells*day/µL)
    -946.0
    (830.29)
    -1000
    (891.82)
    AUEC0-168,w2 (cells*day/µL)
    -987.2
    (997.57)
    -1104
    (947.68)
    AUEC0-168,w3 (cells*day/µL)
    -944.8
    (910.79)
    -1073
    (930.95)
    AUEC0-168,w4 (cells*day/µL)
    -956.3
    (728.52)
    -1196
    (1153.7)
    AUEC0-w12 (cells*day/µL)
    11330
    (9854.1)
    -12280
    (10185)
    AUEC0-w28 (cells*day/µL)
    -26370
    (22794)
    -28860
    (25439)
    16. Other Pre-specified Outcome
    Title Normalized Area Under the Curve Change From Baseline B-lymphocyte Cluster of Differentiation 19 (CD19+ B-cell) Count Time Curve (AUEC) Over the Dosing Interval
    Description Pharmacodynamic Endpoint: Area under the change from baseline CD19+ B-cell count time curve (AUEC) over the first dosing interval on week 1 from time 0 to the time prior to the second dose (AUEC0 168,w1), AUEC over the second dosing interval on week 2 from time 0 to the time prior to the third dose (AUEC0-168,w2), AUEC over the third dosing interval on week 3 from time 0 to the time prior to the fourth dose (AUEC0-168,w3), AUEC over the fourth dosing interval on week 4 from time 0 to 168 hours post dose (AUEC0-168,w4), AUEC from time 0 on week 1 to the time point on week 12 (AUEC0-w12), AUEC from time 0 on week 1 to the time point on week 28 (AUEC0 w28) for the change from baseline CD19+ B-cell count data. The time-normalized AUEC parameters presented were calculated by dividing the respective AUEC by the time interval used to calculate the AUEC.
    Time Frame Baseline (Day 0) to Week 1, 2, 3, 4 12 and 28.

    Outcome Measure Data

    Analysis Population Description
    Pharmacodynamic Analysis Set
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 76 72
    AUEC0-168,w1, normalized (cells/µL)
    -135.0
    (118.88)
    -142.1
    (125.23)
    AUEC0-168,w2, normalized (cells/µL)
    -137.1
    (123.43)
    -155.1
    (133.38)
    AUEC0-168,w3, normalized (cells/µL)
    -134.3
    (121.75)
    -155.7
    (135.47)
    AUEC0-168,w4, normalized (cells/µL)
    -138.7
    (121.62)
    -159.2
    (136.55)
    AUEC0-w12, normalized (cells/µL)
    -143.0
    (121.38)
    -158.7
    (133.02)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 1 (AUEC0-168,w1), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 7.2
    Confidence Interval (2-Sided) 90%
    -31.0 to 45.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 2 (AUEC0-168,w2), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 18.0
    Confidence Interval (2-Sided) 90%
    -21.6 to 57.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera.
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 3 (AUEC0-168,w3), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 21.4
    Confidence Interval (2-Sided) 90%
    -18.3 to 61.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera.
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 4 (AUEC0-168,w4), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 20.4
    Confidence Interval (2-Sided) 90%
    -19.3 to 60.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments comparison: SAIT101 versus MabThera
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 12 (AUEC0-168,w12), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 15.7
    Confidence Interval (2-Sided) 90%
    -23.1 to 54.6
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Statistical Comparison of CD19+ B-cell Pharmacodynamic Parameters (Pharmacodynamic Analysis Set). Area under the pharmacodynamic time effect curve from baseline (Time 0) to Week 28 (AUEC0-168,w28), normalized (cells/µL). The statistical comparison of the between treatments is based on an analysis of covariance (ANOVA) model with fixed effect for treatment and a covariate for baseline value.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Final Values)
    Estimated Value 12.8
    Confidence Interval (2-Sided) 90%
    -26.0 to 51.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments Comparison: SAIT101 versus MabThera.
    17. Other Pre-specified Outcome
    Title Incidence of Antidrug Antibodies (ADA) and Neutralising Antibody (NAb) by Visit
    Description Immunogenicity endpoint: incidence of antidrug antibodies (ADA) and Neutralising Antibody (NAb). Immunogenicity sampling was performed pre-dose at Day 1, weeks 2, 3 and 4 and at any time during the visits at weeks 5, 12, 20 and 28.
    Time Frame Pre-dose on Day 1 to Weeks 5, 12, 20 and 28.

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAS
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 152 156
    Negative
    138
    87.9%
    148
    93.7%
    Positive
    3
    1.9%
    2
    1.3%
    Negative
    3
    1.9%
    2
    1.3%
    Positive
    0
    0%
    0
    0%
    Negative
    143
    91.1%
    152
    96.2%
    Positive
    1
    0.6%
    0
    0%
    Negative
    1
    0.6%
    0
    0%
    Positive
    0
    0%
    0
    0%
    Negative
    138
    87.9%
    148
    93.7%
    Positive
    5
    3.2%
    2
    1.3%
    Negative
    5
    3.2%
    2
    1.3%
    Positive
    0
    0%
    0
    0%
    Negative
    145
    92.4%
    149
    94.3%
    Positive
    2
    1.3%
    0
    0%
    Negative
    2
    1.3%
    0
    0%
    Positive
    0
    0%
    0
    0%
    Negative
    139
    88.5%
    145
    91.8%
    Positive
    2
    1.3%
    0
    0%
    Negative
    2
    1.3%
    0
    0%
    Positive
    0
    0%
    0
    0%
    Negative
    137
    87.3%
    144
    91.1%
    Positive
    3
    1.9%
    0
    0%
    Negative
    3
    1.9%
    0
    0%
    Positive
    0
    0%
    0
    0%
    Negative
    131
    83.4%
    144
    91.1%
    Positive
    7
    4.5%
    4
    2.5%
    Negative
    7
    4.5%
    4
    2.5%
    Positive
    0
    0%
    0
    0%
    Negative
    126
    80.3%
    129
    81.6%
    Positive
    10
    6.4%
    16
    10.1%
    Negative
    9
    5.7%
    16
    10.1%
    Positive
    1
    0.6%
    0
    0%
    18. Other Pre-specified Outcome
    Title Observed Change From Baseline for Immunoglobulins G and M by Scheduled Time
    Description Exploratory pharmacodynamic endpoint: Mean (SD) Change from Baseline of Immunoglobulin (IgG) and immunoglobulin M (IgM) (mg/dL) by Scheduled Time for Each Treatment (Safety Analysis Set). Samples for IgG and IgM assessment were collected at Baseline and Weeks 1, 2, 3, 4, 5, 12, 20 and 28.
    Time Frame Baseline to Weeks 1, 2, 3, 4, 5, 12, 20 and 28.

    Outcome Measure Data

    Analysis Population Description
    Safety Analysis Set (SAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    IgG Week 2
    -0.21
    (132.687)
    -14.79
    (132.64)
    IgG Week 3
    -17.08
    (157.848)
    -30.04
    (124.814)
    IgG Week 4
    -36.31
    (132.326)
    -34.64
    (156.790)
    IgG Week 5
    -34.62
    (162.748)
    -38.21
    (170.758)
    IgG Week 12
    -28.15
    (159.898)
    -2.30
    (202.017)
    IgG Week 20
    -26.86
    (189.937)
    -22.40
    (173.420)
    IgG Week 28
    -19.33
    (200.69)
    8.70
    (238.309)
    IgM Week 2
    0.34
    (18.018)
    4.60
    (28.273)
    IgM Week 3
    0.87
    (25.092)
    2.12
    (32.569)
    IgM Week 4
    0.64
    (31.836)
    0.03
    (30.009)
    IgM Week 5
    -1.91
    (29.521)
    -2.02
    (21.651)
    IgM Week 12
    8.02
    (37.876)
    9.12
    (21.671)
    IgM Week 20
    -12.94
    (46.966)
    -14.35
    (26.012)
    IgM Week 28
    -22.08
    (29.200)
    -20.85
    (37.475)
    19. Other Pre-specified Outcome
    Title Exploratory Analyses of Tumor Response and Time to Event
    Description Exploratory Efficacy Endpoint: Analyses of Tumor Response and Time to Event, as Determined by the Combined International Working Group (IWG) Criteria 2014, Lugano Classification and IWG Criteria 2007 (Central Assessment) (Full Analysis Set)
    Time Frame Baseline (Day 0) to Week 28

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    Complete Response (CR)
    53
    33.8%
    50
    31.6%
    Partial Response (PR)
    47
    29.9%
    55
    34.8%
    Stable Disease (SD)
    21
    13.4%
    25
    15.8%
    Progressive Disease (PD)
    19
    12.1%
    11
    7%
    Unknown (UKN)
    1
    0.6%
    2
    1.3%
    No Evidence of Disease (NED)
    4
    2.5%
    1
    0.6%
    20. Other Pre-specified Outcome
    Title Subgroups and Treatment Interactions of Overall Response Rate (ORR) by Region, Age, Gender and Anti-Drug Antibody (ADA) Status at Week 28.
    Description Exploratory Efficacy Endpoint: Overall Response Rate (ORR) at Week 28 by Region, Age, Gender and Anti-Drug antibody (ADA) status. ADA status through Week 28 is 'Positive' if 'Positive' at any time point, and 'Negative' if 'Negative' at all time points. The 95% CI (confidence interval) for overall response rate (ORR) was calculated using the Exact method. The results presented in this table are based on the non-responder imputed data.
    Time Frame Baseline (Day 0) to Week 28

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set (FAS)
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3 and 4, MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    Measure Participants 157 158
    ORR European Union (%)
    68.5
    43.6%
    70.2
    44.4%
    ORR Other Region (%)
    54.8
    34.9%
    57.8
    36.6%
    ORR Age 10-60 years (%)
    58.6
    37.3%
    70.6
    44.7%
    ORR Age >60 years (%)
    67.1
    42.7%
    58.9
    37.3%
    ORR Gender Female (%)
    72.1
    45.9%
    67.0
    42.4%
    ORR Gender Male (%)
    50.7
    32.3%
    62.9
    39.8%
    ORR ADA Positive (%)
    42.1
    26.8%
    57.1
    36.1%
    ORR ADA Negative (%)
    65.4
    41.7%
    66.7
    42.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Exploratory statistical analysis: Comparison of Overall Response Rate (ORR) by Region (European Union / Other). The interaction p-value for the Region subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.587
    Comments The p-value was calculated using Gail-Simon Test for Qualitative Interactions.
    Method Gail-Simon
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Exploratory statistical analysis. Overall Response Rate by Age Group (18-60 years and >60 years). The interaction p-value for the Age subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.421
    Comments The p-value was calculated using Gail-Simon Test for Qualitative Interactions.
    Method Gail-Simon
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Gender (Male / Female). The interaction p-value for the Gender subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate. The p-value was calculated using Gail-Simon Test for Qualitative Interactions.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.288
    Comments The p-value was calculated using Gail-Simon Test for Qualitative Interactions.
    Method Gail-Simon
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection SAIT101, MabThera
    Comments Exploratory statistical analysis. Comparison of Overall Response Rate (ORR) by Anti-drug Antibody (ADA) status (Positive / Negative). The interaction p-value for the ADA subgroup was calculated based upon the full set of data, and based on a Cochran Mantel Haenszel (CMH) model including treatment, and applicable stratification covariate.
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.588
    Comments The p-value was calculated using Gail-Simon Test for Qualitative Interactions.
    Method Gail-Wilson
    Comments

    Adverse Events

    Time Frame After the participant signed the Informed Consent Form (ICF), but prior to the initiation of study drug, only Serious Adverse Events (SAEs) caused by a protocol mandated procedure should be reported (e.g. SAEs related to invasive procedures such as biopsies). All adverse events were collected for each patient from the start of the first infusion of study drug on Day 1 until the Week 28 Data-cut off.
    Adverse Event Reporting Description All AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) v22.1. If an AE changed from non-SAE to be an SAE, it was treated as a new event and was counted as 2 events in the AE summary. A treatment-emergent AE (TEAE) was defined as any AE with an onset date on or after the date of the first dose of study treatment until Week 28, or the End of Study (EOS) visit, if earlier.
    Arm/Group Title SAIT101 MabThera
    Arm/Group Description SAIT101: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4. MabThera: Dose of 375 mg/m2 body surface area (BSA) intravenous on Weeks 1, 2, 3, and 4.
    All Cause Mortality
    SAIT101 MabThera
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/157 (0%) 1/158 (0.6%)
    Serious Adverse Events
    SAIT101 MabThera
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/157 (1.9%) 4/158 (2.5%)
    Blood and lymphatic system disorders
    Neutropenia 1/157 (0.6%) 1 0/158 (0%) 0
    Cardiac disorders
    Atrial fibrillation 0/157 (0%) 0 1/158 (0.6%) 1
    General disorders
    Sudden cardiac death 0/157 (0%) 0 1/158 (0.6%) 1
    Infections and infestations
    Cystitis klebsiella 1/157 (0.6%) 1 0/158 (0%) 0
    Vestibular neuronitis 0/157 (0%) 0 1/158 (0.6%) 1
    Injury, poisoning and procedural complications
    Fall 0/157 (0%) 0 1/158 (0.6%) 1
    Nervous system disorders
    Paraesthesia 1/157 (0.6%) 1 0/158 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/157 (0%) 0 1/158 (0.6%) 1
    Other (Not Including Serious) Adverse Events
    SAIT101 MabThera
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 85/157 (54.1%) 70/158 (44.3%)
    Blood and lymphatic system disorders
    Neutrpopenia 7/157 (4.5%) 7 1/158 (0.6%) 1
    Gastrointestinal disorders
    Diarrhoea 5/157 (3.2%) 6 5/158 (3.2%) 5
    Nausea 6/157 (3.8%) 7 4/158 (2.5%) 4
    Abdominal pain upper 4/157 (2.5%) 4 3/158 (1.9%) 3
    Abdominal pain 2/157 (1.3%) 2 4/158 (2.5%) 4
    Vomiting 1/157 (0.6%) 1 4/158 (2.5%) 5
    General disorders
    Fatigue 6/157 (3.8%) 7 7/158 (4.4%) 11
    Asthenia 4/157 (2.5%) 4 4/158 (2.5%) 4
    Pyrexia 4/157 (2.5%) 4 2/158 (1.3%) 2
    Injury, poisoning and procedural complications
    Infusion related reaction 18/157 (11.5%) 27 26/158 (16.5%) 30
    Investigations
    Alanine aminotransferase increased 3/157 (1.9%) 4 4/158 (2.5%) 4
    Nervous system disorders
    Headache 9/157 (5.7%) 10 2/158 (1.3%) 5
    Paraesthesia 4/157 (2.5%) 6 0/158 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 4/157 (2.5%) 4 3/158 (1.9%) 3
    Skin and subcutaneous tissue disorders
    Pruritus 4/157 (2.5%) 4 8/158 (5.1%) 8
    Vascular disorders
    Hypertension 4/157 (2.5%) 5 3/158 (1.9%) 3

    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 Medical Director
    Organization Archigen Biotech Ltd
    Phone +44 (0)20 3749 5000
    Email info@archigenbio.com
    Responsible Party:
    Archigen Biotech Limited
    ClinicalTrials.gov Identifier:
    NCT02809053
    Other Study ID Numbers:
    • AGB002
    First Posted:
    Jun 22, 2016
    Last Update Posted:
    Oct 8, 2020
    Last Verified:
    Sep 1, 2020