Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01077518

Acronym

A+B

Enrollment

346

Registered

2010-03-01

Start date

2010-08-26

Completion date

2018-12-26

Last updated

2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Follicular

Keywords

Refractory, Safety, Efficacy, Rituximab refractory, Oncology, Ofatumumab, Bendamustine, Indolent B-cell Non- Hodgkin's Lymphoma Unresponsive, Rituximab, Rituximab-Containing Regimen

Brief summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Detailed description

Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients with follicular lymphoma that has relapsed following rituximab-containing therapy. Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment. Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may provide additional clinical benefit and efficacy to those who no longer respond to rituximab or rituximab-containing regimens. The objective of this study is to determine the effect of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Interventions

DRUGOfatumumab

Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion.

DRUGBendamustine infusion

Bendamustine 100 mg/vial, injection

DRUGOfatumumab and Bendamustine infusions (Arm A)

Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.

DRUGBendamustine infusion (Arm B)

Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

randomized open label bendamustine monotherapy vs. ofatumumab

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Indolent lymphoma including Grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage II. Tumor verified CD20+ and CT imaging done at screening verifying disease * Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen * Indolent lymphoma including grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass \> 5 cm in any direction) * ECOG Performance Status of 0, 1, or 2 * Life expectancy of at least 6 months * 18 years or older * Signed, written informed consent

Exclusion criteria

* Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma * Previous allogeneic stem cell transplant * Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy in the past 12 months * Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two or to more than 3 vertebral bodies * High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within 3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at the time of randomization * Prior bendamustine treatment within 1 year of randomization not resulting in a CR or PR for at least 6 months * Treatment with anti-CD20 monoclonal antibody within 3 months of randomization * Known CNS involvement of indolent lymphoma * Other past or current malignancy. Subjects free of malignancy for at least 5 years or have history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment * Clinically significant cardiac disease * History of significant cerebrovascular disease or event with significant symptoms * Positive serology for Hepatitis B * Current active liver or biliary disease (except Gibber's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease) * Known HIV positive * Abnormal/inadequate blood values, liver and kidney function * Current participation in other clinical study * Inability to comply with the protocol activities * Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Design outcomes

Primary

Measure	Time frame	Description
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	From randomization to the date of first documented disease progression or death due to any cause (67.5 months)	PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Secondary

Measure	Time frame	Description
Overall Response Rate (ORR) in All Participants Per IRC	From randomization until the 217th PFS event occurred, up to about 67.5 months	ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.
Overall Response Rate (ORR) in Participants With FL Per IRC	From randomization until the 217th PFS event occurred, up to about 67.5 months	ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.
Overall Survival (OS) in All Participants	From randomization up to about 89 months	The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.
Overall Survival (OS) in Participants With FL	From randomization up to about 89 months	The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.
Time to Response in All Participants Per IRC	From randomization to up to 67.5 months	Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.
Time to Response in Participants With FL Per IRC	From randomization to up to 67.5 months	Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.
Duration of Response in All Participants Per IRC	time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months	Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.
Duration of Response in Participants With FL Per IRC	time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months	Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.
Time to Progression in All Participants Per IRC	From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months	Time from randomization until disease progression
Time to Progression in Participants With FL Per IRC	From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months	Time from randomization until disease progression
Time to Next Therapy in All Participants Per IRC	from randomization date to the date of receiving the next line treatment or death, up to 67.5 months	Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types.
Time to Next Therapy in Participants With FL Per IRC	from randomization date to the date of receiving the next line treatment or death, up to 67.5 months	Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types
PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day
Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC	From randomization to the date of first documented disease progression or death due to any cause (67.5 months)	PFS is defined as the time interval between randomization until disease progression or death (due to any cause).
PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) \*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) \*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions
PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions
Reduction in Tumor Size	baseline, post-baseline (up to 55 months)	Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan.
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	This is the number of participants with change in ECOG status. Change is measured categorically by Improvement, deterioration and No change. Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead
Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)	From randomization up to about 67.5 months	A summary by responders and non-responders
Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine	From randomization until the 217th PFS event occurred, up to about 67.8 months	ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days	at scheduled visits for actual values as well as for change from baseline
Plasma Ofatumumab Concentrations	C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up	Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time.
B-cell Monitoring (CD19+, CD20+)	C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days	The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery.
Human Anti-chimeric Antibodies (HACA) Over Time	At Baseline and Cycle 1 day 1	The number of participants with positive and negative baseline HACA results
PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days	The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day

Countries

Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hong Kong, Italy, Japan, Poland, Puerto Rico, Russia, Slovakia, Ukraine, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Ofa + Benda (Arm A) ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	173
Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	173
Total	346

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Optional Ofa Phase	Physician Decision	0	0	1
Optional Ofa Phase	Study Terminated by Sponsor	0	0	12
Optional Ofa Phase	Withdrawal by Subject	0	0	3
Treatment Phase - no Optional Ofa	Lost to Follow-up	8	4	0
Treatment Phase - no Optional Ofa	Physician Decision	10	11	0
Treatment Phase - no Optional Ofa	Study Terminated by Sponsor	28	22	0
Treatment Phase - no Optional Ofa	Withdrawal by Subject	32	28	0

Baseline characteristics

Characteristic	Benda (Arm B)	Ofa + Benda (Arm A)	Total
Age, Continuous	62.6 years STANDARD_DEVIATION 63	61.8 years STANDARD_DEVIATION 61	62.2 years STANDARD_DEVIATION 62
Baseline Absolute Lymphocyte Count (ALC) >= LLN	131 Participants	131 Participants	262 Participants
Baseline Absolute Lymphocyte Count (ALC) < (Lower limit of normal (LLN)	41 Participants	41 Participants	82 Participants
Baseline Absolute Lymphocyte Count (ALC) Missing	1 Participants	1 Participants	2 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	10 Participants	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants	163 Participants	330 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation GG	18 Participants	21 Participants	39 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation Missing	34 Participants	14 Participants	48 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation TG	59 Participants	77 Participants	136 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation TT	62 Participants	61 Participants	123 Participants
FLIPI-1 Score at Screening 0 - 2	93 participants	100 participants	193 participants
FLIPI-1 Score at Screening 3 - 5	75 participants	66 participants	141 participants
FLIPI-1 Score at Screening Missing	5 participants	7 participants	12 participants
Human Anti-Chimeric Antibodies (HACA) Missing	34 Participants	11 Participants	45 Participants
Human Anti-Chimeric Antibodies (HACA) Negative	116 Participants	141 Participants	257 Participants
Human Anti-Chimeric Antibodies (HACA) Positive	23 Participants	21 Participants	44 Participants
Sex: Female, Male Female	71 Participants	72 Participants	143 Participants
Sex: Female, Male Male	102 Participants	101 Participants	203 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	66 / 172	71 / 170	15 / 32	137 / 342
other Total, other adverse events	158 / 172	162 / 170	21 / 32	320 / 342
serious Total, serious adverse events	72 / 172	84 / 170	8 / 32	160 / 342

Outcome results

Primary

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Time frame: From randomization to the date of first documented disease progression or death due to any cause (67.5 months)

Population: ITT: The Intent-to-Treat (ITT) population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	16.66 months
Benda (Arm B)	Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	13.83 months

p-value: 0.13995% CI: [0.62, 1.07]Stratified Log-Rank

Secondary

B-cell Monitoring (CD19+, CD20+)

The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery.

Time frame: C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	B-cell Monitoring (CD19+, CD20+)	9M post-D252: CD45+CD20+	925.0 percentage change from baseline	Standard Deviation 3803.1
Ofa + Benda (Arm A)	B-cell Monitoring (CD19+, CD20+)	C5D1: CD45+CD19+	-94.0 percentage change from baseline	Standard Deviation 16.6
Ofa + Benda (Arm A)	B-cell Monitoring (CD19+, CD20+)	1M post-D252: CD45+CD20+	-100.0 percentage change from baseline	Standard Deviation 0
Ofa + Benda (Arm A)	B-cell Monitoring (CD19+, CD20+)	C1D1: CD45+CD20+	-100.0 percentage change from baseline	Standard Deviation 0
Ofa + Benda (Arm A)	B-cell Monitoring (CD19+, CD20+)	1M post-D252: CD45+CD19+	-82.0 percentage change from baseline	Standard Deviation 77
Ofa + Benda (Arm A)	B-cell Monitoring (CD19+, CD20+)	9M post-D252: CD45+CD19+	1421.0 percentage change from baseline	Standard Deviation 5721.6
Benda (Arm B)	B-cell Monitoring (CD19+, CD20+)	C5D1: CD45+CD19+	-97.0 percentage change from baseline	—
Benda (Arm B)	B-cell Monitoring (CD19+, CD20+)	C1D1: CD45+CD20+	-98.0 percentage change from baseline	—

Secondary

Duration of Response in All Participants Per IRC

Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.

Time frame: time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Duration of Response in All Participants Per IRC	17.71 months
Benda (Arm B)	Duration of Response in All Participants Per IRC	14.49 months

Secondary

Duration of Response in Participants With FL Per IRC

Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.

Time frame: time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Duration of Response in Participants With FL Per IRC	16.39 months
Benda (Arm B)	Duration of Response in Participants With FL Per IRC	11.20 months

Secondary

Human Anti-chimeric Antibodies (HACA) Over Time

The number of participants with positive and negative baseline HACA results

Time frame: At Baseline and Cycle 1 day 1

Population: Safety: The Safety population included all subjects who received at least one dose of a study drug

Arm	Measure	Group	Value (NUMBER)
Ofa + Benda (Arm A)	Human Anti-chimeric Antibodies (HACA) Over Time	Baseline: Negative	145 Participants
Ofa + Benda (Arm A)	Human Anti-chimeric Antibodies (HACA) Over Time	Baseline: Positive	25 Participants
Ofa + Benda (Arm A)	Human Anti-chimeric Antibodies (HACA) Over Time	C1D1: Negative	145 Participants
Ofa + Benda (Arm A)	Human Anti-chimeric Antibodies (HACA) Over Time	C1D1:Positive	25 Participants
Benda (Arm B)	Human Anti-chimeric Antibodies (HACA) Over Time	C1D1:Positive	23 Participants
Benda (Arm B)	Human Anti-chimeric Antibodies (HACA) Over Time	Baseline: Negative	119 Participants
Benda (Arm B)	Human Anti-chimeric Antibodies (HACA) Over Time	C1D1: Negative	119 Participants
Benda (Arm B)	Human Anti-chimeric Antibodies (HACA) Over Time	Baseline: Positive	23 Participants

Secondary

Overall Response Rate (ORR) in All Participants Per IRC

ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.

Time frame: From randomization until the 217th PFS event occurred, up to about 67.5 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (NUMBER)
Ofa + Benda (Arm A)	Overall Response Rate (ORR) in All Participants Per IRC	73 Percentage of participants
Benda (Arm B)	Overall Response Rate (ORR) in All Participants Per IRC	75 Percentage of participants

Comparison: for All participantsp-value: 0.8003Cochran-Mantel-Haenszel

Secondary

Overall Response Rate (ORR) in Participants With FL Per IRC

Time frame: From randomization until the 217th PFS event occurred, up to about 67.5 months

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Value (NUMBER)
Ofa + Benda (Arm A)	Overall Response Rate (ORR) in Participants With FL Per IRC	77 Percentage of participants
Benda (Arm B)	Overall Response Rate (ORR) in Participants With FL Per IRC	76 Percentage of participants

Comparison: for Follicular Lymphoma (FL) participantsp-value: 0.613Cochran-Mantel-Haenszel

Secondary

Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine

Time frame: From randomization until the 217th PFS event occurred, up to about 67.8 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (NUMBER)
Ofa + Benda (Arm A)	Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine	17 Percentage of participants

Secondary

Overall Survival (OS) in All Participants

The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.

Time frame: From randomization up to about 89 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Overall Survival (OS) in All Participants	59.76 months
Benda (Arm B)	Overall Survival (OS) in All Participants	58.22 months

Comparison: for All patientsp-value: 0.404695% CI: [0.62, 1.21]Stratified Log Rank

Secondary

Overall Survival (OS) in Participants With FL

The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.

Time frame: From randomization up to about 89 months

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Overall Survival (OS) in Participants With FL	NA months
Benda (Arm B)	Overall Survival (OS) in Participants With FL	53.59 months

Comparison: for FL participantsp-value: 0.376895% CI: [0.55, 1.25]Stratified Log Rank

Secondary

Plasma Ofatumumab Concentrations

Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time.

Time frame: C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up

Population: Pharmacokinetic Population: The Pharmacokinetic Population included all subjects who provided at least one evaluable PK concentration

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C1D1 pre-dose	1.1 ug/mL	Standard Deviation 13.97
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C1D1 End of infusion (EOI)	262.0 ug/mL	Standard Deviation 83.97
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C1D1 1h post-EOI	283.2 ug/mL	Standard Deviation 227.11
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C7D1 pre-dose	153.6 ug/mL	Standard Deviation 74.45
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C7D1 EOI	402.2 ug/mL	Standard Deviation 148.78
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C7D1 1h post-EOI	419.1 ug/mL	Standard Deviation 167.44
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C12D1 pre-dose	143.5 ug/mL	Standard Deviation 75.58
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	C12D1 EOI	392.0 ug/mL	Standard Deviation 130.64
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	12M post-D252	0.9 ug/mL	Standard Deviation 2.53
Ofa + Benda (Arm A)	Plasma Ofatumumab Concentrations	Withdrawal	29.6 ug/mL	Standard Deviation 42.58

Secondary

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym

The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day

Time frame: administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score C5D1	1.7 scores on a scale	Standard Deviation 3.97
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score C11D1	1.1 scores on a scale	Standard Deviation 4.58
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score D252	-5.0 scores on a scale	Standard Deviation 9.64
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score 12M post-D252	0.9 scores on a scale	Standard Deviation 5.59
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score Withdrawal	-4.1 scores on a scale	Standard Deviation 6.78
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score C5D1	0.2 scores on a scale	Standard Deviation 4.94
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score C11D1	-1.2 scores on a scale	Standard Deviation 6.09
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score D252	-1.6 scores on a scale	Standard Deviation 3.24
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Soc./Fam. well-being score 12M post-D252	0.3 scores on a scale	Standard Deviation 5.21
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score Withdrawal	0.9 scores on a scale	Standard Deviation 7.69
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score: C5D1	0.2 scores on a scale	Standard Deviation 4.36
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score C11D1	1.4 scores on a scale	Standard Deviation 4.12
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score D252	-5.3 scores on a scale	Standard Deviation 2.08
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score 12M post-D252	1.5 scores on a scale	Standard Deviation 4.45
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score Withdrawal	-2.2 scores on a scale	Standard Deviation 4.8
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score C5D1	0.7 scores on a scale	Standard Deviation 5.08
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score C11D1	1.1 scores on a scale	Standard Deviation 5.62
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score D252	-4.3 scores on a scale	Standard Deviation 5.69
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score 12M post-D252	1.1 scores on a scale	Standard Deviation 4.82
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score Withdrawal	-2.3 scores on a scale	Standard Deviation 4.27
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score C5D1	3.6 scores on a scale	Standard Deviation 7.88
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score C11D1	4.4 scores on a scale	Standard Deviation 8.88
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score D252	-2.3 scores on a scale	Standard Deviation 14.98
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score 12M post-D252	3.2 scores on a scale	Standard Deviation 7.77
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score Withdrawal	-1.4 scores on a scale	Standard Deviation 6.16
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI C1D1	4.5 scores on a scale	Standard Deviation 14.64
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI C11D1	6.7 scores on a scale	Standard Deviation 15.84
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI D252	-11.7 scores on a scale	Standard Deviation 28.75
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI 12M post-D252	5.1 scores on a scale	Standard Deviation 15.94
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI Withdrawal	-7.8 scores on a scale	Standard Deviation 14.55
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score C5D1	2.7 scores on a scale	Standard Deviation 12.82
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score C11D1	2.3 scores on a scale	Standard Deviation 13
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total score D252	-16.2 scores on a scale	Standard Deviation 15.71
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score 12M post-D252	3.7 scores on a scale	Standard Deviation 13.75
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score Withdrawal	-7.7 scores on a scale	Standard Deviation 11.91
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score C5D1	6.3 scores on a scale	Standard Deviation 18.78
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score C11D1	6.7 scores on a scale	Standard Deviation 18.95
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score D252	-18.6 scores on a scale	Standard Deviation 30.5
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score 12M post-D252	6.9 scores on a scale	Standard Deviation 19.78
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score Withdrawal	-9.1 scores on a scale	Standard Deviation 15.96
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score D252	-7.7 scores on a scale	Standard Deviation 44.64
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score: C5D1	-2.8 scores on a scale	Standard Deviation 5.54
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score C5D1	-1.0 scores on a scale	Standard Deviation 9.65
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score C11D1	1.0 scores on a scale	Standard Deviation 4.25
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score C5D1	-4.7 scores on a scale	Standard Deviation 15.26
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score D252	1.7 scores on a scale	Standard Deviation 9.18
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score C11D1	2.3 scores on a scale	Standard Deviation 6.53
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score 12M post-D252	1.3 scores on a scale	Standard Deviation 4.52
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score C5D1	-5.8 scores on a scale	Standard Deviation 23.05
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Physical well-being score Withdrawal	-1.5 scores on a scale	Standard Deviation 6.61
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score D252	0.7 scores on a scale	Standard Deviation 18.22
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score C5D1	-0.5 scores on a scale	Standard Deviation 5.24
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score C11D1	0.1 scores on a scale	Standard Deviation 14.11
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score C11D1	-1.1 scores on a scale	Standard Deviation 6.45
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score 12M post-D252	2.0 scores on a scale	Standard Deviation 7.71
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score D252	-5.4 scores on a scale	Standard Deviation 9.08
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score Withdrawal	-6.5 scores on a scale	Standard Deviation 18.53
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Soc./Fam. well-being score 12M post-D252	-1.3 scores on a scale	Standard Deviation 4.81
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Lymphoma subscale score Withdrawal	-1.6 scores on a scale	Standard Deviation 7.65
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Social/Family well-being score Withdrawal	0.3 scores on a scale	Standard Deviation 3.53
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total score D252	-8.4 scores on a scale	Standard Deviation 31.22
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score C5D1	0.1 scores on a scale	Standard Deviation 4.1
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI C1D1	-5.3 scores on a scale	Standard Deviation 18.67
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score C11D1	0.7 scores on a scale	Standard Deviation 3.9
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score C11D1	2.4 scores on a scale	Standard Deviation 18.73
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score D252	-2.5 scores on a scale	Standard Deviation 5.89
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI C11D1	2.7 scores on a scale	Standard Deviation 13.24
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score 12M post-D252	0.7 scores on a scale	Standard Deviation 4.15
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score 12M post-D252	1.5 scores on a scale	Standard Deviation 13.44
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Emotional well-being score Withdrawal	-2.3 scores on a scale	Standard Deviation 4.12
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI D252	0.2 scores on a scale	Standard Deviation 36.56
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score C5D1	-1.5 scores on a scale	Standard Deviation 5.79
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymph. Tot. score 12M post-D252	3.5 scores on a scale	Standard Deviation 18.77
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score C11D1	-0.6 scores on a scale	Standard Deviation 5.52
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI 12M post-D252	4.1 scores on a scale	Standard Deviation 14.62
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score D252	-2.2 scores on a scale	Standard Deviation 13.76
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-G Total Score Withdrawal	-5.3 scores on a scale	Standard Deviation 13.1
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score 12M post-D252	0.8 scores on a scale	Standard Deviation 5.55
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	FACT-Lymphoma TOI Withdrawal	-4.3 scores on a scale	Standard Deviation 16.77
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym	Functional well-being score Withdrawal	-1.6 scores on a scale	Standard Deviation 6.47

Secondary

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym

Time frame: administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score C5D1	0.0 scores on a scale	Standard Deviation 4.66
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score C11D1	0.9 scores on a scale	Standard Deviation 4.16
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score D252	2.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score 12M post-D252	0.5 scores on a scale	Standard Deviation 6.15
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score Withdrawal	-5.0 scores on a scale	Standard Deviation 7.64
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score C5D1	-0.1 scores on a scale	Standard Deviation 4.38
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score C11D1	-1.6 scores on a scale	Standard Deviation 5.38
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score D252	2.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Soc./Fam. well-being score 12M post-D252	0.3 scores on a scale	Standard Deviation 5.35
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score Withdrawal	1.1 scores on a scale	Standard Deviation 5.79
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score C5D1	1.8 scores on a scale	Standard Deviation 3.65
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score C11D1	1.2 scores on a scale	Standard Deviation 4.3
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score D252	-6.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score 12M post-D252	1.5 scores on a scale	Standard Deviation 4.85
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score Withdrawal	-2.3 scores on a scale	Standard Deviation 5.28
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score C5D1	0.1 scores on a scale	Standard Deviation 4.58
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score C11D1	0.5 scores on a scale	Standard Deviation 4.99
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score D252	-6.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score 12M post-D252	0.7 scores on a scale	Standard Deviation 4.99
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score Withdrawal	-1.6 scores on a scale	Standard Deviation 4.06
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score C5D1	3.7 scores on a scale	Standard Deviation 7.33
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score C11D1	3.7 scores on a scale	Standard Deviation 8.7
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score D252	-18.7 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score 12M post-D252	2.6 scores on a scale	Standard Deviation 8
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score Withdrawal	-2.5 scores on a scale	Standard Deviation 6.76
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI C5D1	3.7 scores on a scale	Standard Deviation 13.51
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI C11D1	5.0 scores on a scale	Standard Deviation 14.74
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI D252	-2.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI 12M post-D252	3.7 scores on a scale	Standard Deviation 16.94
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI Withdrawal	-9.2 scores on a scale	Standard Deviation 15.4
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score C5D1	1.7 scores on a scale	Standard Deviation 11.4
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score C11D1	1.0 scores on a scale	Standard Deviation 12.17
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score D252	-8.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score 12M post-D252	2.9 scores on a scale	Standard Deviation 14.62
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score C5D1	5.4 scores on a scale	Standard Deviation 16.55
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score C11D1	4.7 scores on a scale	Standard Deviation 17.52
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score D252	-6.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score 12M post-D252	5.5 scores on a scale	Standard Deviation 20.73
Ofa + Benda (Arm A)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score Withdrawal	-10.4 scores on a scale	Standard Deviation 15.02
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score Withdrawal	-1.5 scores on a scale	Standard Deviation 7.15
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score C5D1	-3.4 scores on a scale	Standard Deviation 5.87
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI Withdrawal	-1.7 scores on a scale	Standard Deviation 15.26
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score C11D1	1.2 scores on a scale	Standard Deviation 4.74
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score C5D1	-2.2 scores on a scale	Standard Deviation 9.71
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score D252	7.5 scores on a scale	Standard Deviation 17.68
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score C5D1	-8.0 scores on a scale	Standard Deviation 24.11
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score 12M post-D252	1.8 scores on a scale	Standard Deviation 4.37
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score C11D1	2.4 scores on a scale	Standard Deviation 6.79
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Physical well-being score Withdrawal	-0.6 scores on a scale	Standard Deviation 6.31
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score C5D1	-5.8 scores on a scale	Standard Deviation 16.32
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score C5D1	-0.7 scores on a scale	Standard Deviation 5.48
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score D252	7.0 scores on a scale	Standard Deviation 38.18
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score C11D1	-1.4 scores on a scale	Standard Deviation 5.61
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score Withdrawal	-3.1 scores on a scale	Standard Deviation 18.48
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score D252	2.5 scores on a scale	Standard Deviation 3.54
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score 12M post-D252	2.2 scores on a scale	Standard Deviation 6.63
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Soc./Fam. well-being score 12M post-D252	-1.9 scores on a scale	Standard Deviation 5.14
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score C11D1	0.2 scores on a scale	Standard Deviation 13.96
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Social/Family well-being score Withdrawal	0.6 scores on a scale	Standard Deviation 2.57
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Lymphoma subscale score Withdrawal	-0.4 scores on a scale	Standard Deviation 7.17
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score C5D1	-0.0 scores on a scale	Standard Deviation 4.41
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score C11D1	2.7 scores on a scale	Standard Deviation 19.6
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score C11D1	0.5 scores on a scale	Standard Deviation 4.1
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI C5D1	-7.3 scores on a scale	Standard Deviation 18.77
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score D252	-1.0 scores on a scale	Standard Deviation 9.9
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score D252	16.0 scores on a scale	Standard Deviation 39.6
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score 12M post-D252	0.6 scores on a scale	Standard Deviation 2.68
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI C11D1	3.6 scores on a scale	Standard Deviation 14.01
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Emotional well-being score Withdrawal	-1.9 scores on a scale	Standard Deviation 4.59
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score 12M post-D252	3.6 scores on a scale	Standard Deviation 14.44
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score C5D1	-1.7 scores on a scale	Standard Deviation 5.74
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI D252	21.5 scores on a scale	Standard Deviation 71.42
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score C11D1	-0.0 scores on a scale	Standard Deviation 4.84
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-G Total score 12M post-D252	1.4 scores on a scale	Standard Deviation 11.25
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score D252	7.0 scores on a scale	Standard Deviation 15.56
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma TOI 12M post-D252	4.9 scores on a scale	Standard Deviation 12.32
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	Functional well-being score 12M post-D252	1.0 scores on a scale	Standard Deviation 5.75
Benda (Arm B)	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym	FACT-Lymphoma Tot. score D252	23.0 scores on a scale	Standard Deviation 77.78

Secondary

PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D

The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) \*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)

Time frame: administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score C5D1	5.8 scores on a scale	Standard Deviation 18.1
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score C11D1	12.9 scores on a scale	Standard Deviation 19.38
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score D252	-11.7 scores on a scale	Standard Deviation 16.07
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score 12M post-D252	14.7 scores on a scale	Standard Deviation 19.71
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score Withdrawal	-14.7 scores on a scale	Standard Deviation 17.03
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs C5D1	0.21 scores on a scale	Standard Deviation 0.24
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs C11D1	0.1 scores on a scale	Standard Deviation 0.22
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs D252	-0.4 scores on a scale	Standard Deviation 0.79
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs 12M post-D252	0.0 scores on a scale	Standard Deviation 0.22
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs Withdrawal	-0.2 scores on a scale	Standard Deviation 0.22
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs D252	0.1 scores on a scale	Standard Deviation 0.36
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score C5D1	-3.8 scores on a scale	Standard Deviation 19.25
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs C5D1	0.0 scores on a scale	Standard Deviation 0.22
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score C11D1	2.7 scores on a scale	Standard Deviation 18.96
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs Withdrawal	0.1 scores on a scale	Standard Deviation 0.32
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score D252	-0.8 scores on a scale	Standard Deviation 19.66
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs C11D1	0.0 scores on a scale	Standard Deviation 0.19
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score 12M post-D252	7.1 scores on a scale	Standard Deviation 19.14
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EuroQoL Tariffs 12M post-D252	0.0 scores on a scale	Standard Deviation 0.2
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D	EQ5D01-EQ VAS Score Withdrawal	0.7 scores on a scale	Standard Deviation 34.41

Secondary

PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D

Time frame: administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score C5D1	5.5 scores on a scale	Standard Deviation 19.25
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score C11D1	12.9 scores on a scale	Standard Deviation 19.88
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score D252	0.00 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score 12M post-D252	14.2 scores on a scale	Standard Deviation 21.47
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score Withdrawal	-18.5 scores on a scale	Standard Deviation 13.35
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs C5D1	0.0 scores on a scale	Standard Deviation 0.24
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs C11D1	0.1 scores on a scale	Standard Deviation 0.22
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs D252	0.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs 12M post-D252	0.0 scores on a scale	Standard Deviation 0.22
Ofa + Benda (Arm A)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs Withdrawal	-0.1 scores on a scale	Standard Deviation 0.16
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs D252	0.4 scores on a scale	Standard Deviation 0.53
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score C5D1	-6.5 scores on a scale	Standard Deviation 18.83
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs C5D1	0.0 scores on a scale	Standard Deviation 0.23
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score C11D1	1.1 scores on a scale	Standard Deviation 20.87
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs Withdrawal	0.1 scores on a scale	Standard Deviation 0.36
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score D252	-7.5 scores on a scale	Standard Deviation 31.82
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs C11D1	0.0 scores on a scale	Standard Deviation 0.2
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score 12M post-D252	6.7 scores on a scale	Standard Deviation 20.77
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EuroQoL Tariffs 12M post-D252	0.0 scores on a scale	Standard Deviation 0.16
Benda (Arm B)	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D	EQ5D01-EQ VAS Score Withdrawal	5.4 scores on a scale	Standard Deviation 37.78

Secondary

PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)

The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions

Time frame: administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment C11D1	2.6 scores on a scale	Standard Deviation 1.73
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment 12M post D252	2.4 scores on a scale	Standard Deviation 1.95
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment D252	5.3 scores on a scale	Standard Deviation 2.52
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment Withdrawal	5.4 scores on a scale	Standard Deviation 3.32
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment C5D1	2.8 scores on a scale	Standard Deviation 1.81
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment Withdrawal	4.3 scores on a scale	Standard Deviation 2.63
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment C5D1	3.8 scores on a scale	Standard Deviation 2.29
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment C11D1	2.5 scores on a scale	Standard Deviation 1.74
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment D252	4.8 scores on a scale	Standard Deviation 2.56
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)	Change in health treatment 12M post D252	2.6 scores on a scale	Standard Deviation 1.99

Secondary

PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)

The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions

Time frame: administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment C11D1	2.7 scores on a scale	Standard Deviation 1.73
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment 12M post D252	2.7 scores on a scale	Standard Deviation 2.11
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment D252	3.0 scores on a scale	—
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment Withdrawal	7.2 scores on a scale	Standard Deviation 1.79
Ofa + Benda (Arm A)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment C5D1	2.9 scores on a scale	Standard Deviation 1.93
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment Withdrawal	4.2 scores on a scale	Standard Deviation 2.96
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment C5D1	3.9 scores on a scale	Standard Deviation 2.25
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment C11D1	2.4 scores on a scale	Standard Deviation 1.56
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment D252	4.5 scores on a scale	Standard Deviation 3.54
Benda (Arm B)	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)	Change in health treatment 12M post D252	2.1 scores on a scale	Standard Deviation 1.54

Secondary

Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC

PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Time frame: From randomization to the date of first documented disease progression or death due to any cause (67.5 months)

Population: Subjects in ITT with Follicular Lymphoma (FL). ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC	16.62 months
Benda (Arm B)	Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC	12.12 months

p-value: 0.107695% CI: [0.55, 1.06]Stratified Log-Rank

Secondary

Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)

at scheduled visits for actual values as well as for change from baseline

Time frame: Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days

Population: Safety: The Safety population included all subjects who received at least one dose of a study drug (Ofa+benda arm only).

Arm	Measure	Group	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgA @ screening (BL)	0.7 g/L	—
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgG @ screening	4.7 g/L	—
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgM @ screening	0.6 g/L	—
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgA @ C1D1	1.3 g/L	Standard Deviation 0.78
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgG @ C1D1	7.7 g/L	Standard Deviation 3.96
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgM @ C1D1	1.4 g/L	Standard Deviation 4.15
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgA @ 1M post-D252	1.1 g/L	Standard Deviation 0.74
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgG @ 1M post-D252	7.1 g/L	Standard Deviation 2.9
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgM @ 1M post-D252	0.6 g/L	Standard Deviation 0.68
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgA @ 6M post D252	1.1 g/L	Standard Deviation 0.59
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgG @ 6M post D252	7.3 g/L	Standard Deviation 2.97
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgM @ 6M post D252	0.7 g/L	Standard Deviation 0.97
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgA @ 12M post D252	1.1 g/L	Standard Deviation 1.2
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgG @12M post D252	7.1 g/L	Standard Deviation 3.31
Ofa + Benda (Arm A)	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)	IgM @ 12M post D252	0.7 g/L	Standard Deviation 0.66

Secondary

Reduction in Tumor Size

Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan.

Time frame: baseline, post-baseline (up to 55 months)

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEAN)	Dispersion
Ofa + Benda (Arm A)	Reduction in Tumor Size	-33.2 mm^2	Standard Deviation 44.08
Benda (Arm B)	Reduction in Tumor Size	-32.8 mm^2	Standard Deviation 36.83

Secondary

Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

This is the number of participants with change in ECOG status. Change is measured categorically by Improvement, deterioration and No change. Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead

Time frame: administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Group	Value (NUMBER)
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C5D1: Deteriorated	18 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C5D1: Improved	30 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C5D1: No Change	94 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C11D1: Deteriorated	13 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C11D1: Improved	27 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C11D1: No Change	75 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	12M post D252: Deteriorated	9 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	12M post-D252: Improved	17 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	12M post-D252: No Change	44 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	Withdrawal: Deteriorated	7 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	Withdrawal: Improved	2 participants
Ofa + Benda (Arm A)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	Withdrawal: No Change	8 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	Withdrawal: Improved	2 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C5D1: Deteriorated	24 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	12M post D252: Deteriorated	6 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C5D1: Improved	22 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	Withdrawal: Deteriorated	8 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C5D1: No Change	88 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	12M post-D252: Improved	12 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C11D1: Deteriorated	9 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	Withdrawal: No Change	11 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C11D1: Improved	23 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	12M post-D252: No Change	38 participants
Benda (Arm B)	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status	C11D1: No Change	58 participants

Secondary

Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)

A summary by responders and non-responders

Time frame: From randomization up to about 67.5 months

Population: Safety: The Safety population included all subjects who received at least one dose of a study drug. Per protocol, HAHA was only collected for subjects in the Ofa+benda arm.

Arm	Measure	Group	Value (NUMBER)
Ofa + Benda (Arm A)	Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)	# of participants with post-Ofa HAHA results	151 Participants
Ofa + Benda (Arm A)	Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)	with at least 1 conf. +ve post-Ofa HAHA result	1 Participants
Ofa + Benda (Arm A)	Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)	-ve post-Ofa HAHA results, no Ofa conc. <200 ug/mL	6 Participants
Ofa + Benda (Arm A)	Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)	-ve post-Ofa HAHA, at least 1 Ofa conc<200ug/mL	144 Participants

Secondary

Time to Next Therapy in All Participants Per IRC

Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types.

Time frame: from randomization date to the date of receiving the next line treatment or death, up to 67.5 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Time to Next Therapy in All Participants Per IRC	39.82 Months
Benda (Arm B)	Time to Next Therapy in All Participants Per IRC	26.94 Months

Secondary

Time to Next Therapy in Participants With FL Per IRC

Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types

Time frame: from randomization date to the date of receiving the next line treatment or death, up to 67.5 months

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Time to Next Therapy in Participants With FL Per IRC	36.96 Months
Benda (Arm B)	Time to Next Therapy in Participants With FL Per IRC	25.43 Months

Secondary

Time to Progression in All Participants Per IRC

Time from randomization until disease progression

Time frame: From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Time to Progression in All Participants Per IRC	19.35 Months
Benda (Arm B)	Time to Progression in All Participants Per IRC	16.56 Months

Secondary

Time to Progression in Participants With FL Per IRC

Time from randomization until disease progression

Time frame: From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Time to Progression in Participants With FL Per IRC	19.35 Months
Benda (Arm B)	Time to Progression in Participants With FL Per IRC	13.80 Months

Secondary

Time to Response in All Participants Per IRC

Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.

Time frame: From randomization to up to 67.5 months

Population: ITT: The ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Time to Response in All Participants Per IRC	2.86 Months
Benda (Arm B)	Time to Response in All Participants Per IRC	2.89 Months

Secondary

Time to Response in Participants With FL Per IRC

Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.

Time frame: From randomization to up to 67.5 months

Population: Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm	Measure	Value (MEDIAN)
Ofa + Benda (Arm A)	Time to Response in Participants With FL Per IRC	2.86 Months
Benda (Arm B)	Time to Response in Participants With FL Per IRC	2.86 Months

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Intervention model description

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

B-cell Monitoring (CD19+, CD20+)

Duration of Response in All Participants Per IRC

Duration of Response in Participants With FL Per IRC

Human Anti-chimeric Antibodies (HACA) Over Time

Overall Response Rate (ORR) in All Participants Per IRC

Overall Response Rate (ORR) in Participants With FL Per IRC

Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine

Overall Survival (OS) in All Participants

Overall Survival (OS) in Participants With FL

Plasma Ofatumumab Concentrations

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym

PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D

PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D

PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)

PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)

Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC

Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)

Reduction in Tumor Size

Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)

Time to Next Therapy in All Participants Per IRC

Time to Next Therapy in Participants With FL Per IRC

Time to Progression in All Participants Per IRC

Time to Progression in Participants With FL Per IRC

Time to Response in All Participants Per IRC

Time to Response in Participants With FL Per IRC