Trial Outcomes & Findings for Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy (NCT NCT01077518)

NCT ID: NCT01077518

Last Updated: 2020-03-27

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

346 participants

Primary outcome timeframe

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

Results posted on

2020-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	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	Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	Optional Ofa Participants from the Benda arm who opted for optional ofatumumab therapy post disease progression.
Treatment Phase - no Optional Ofa STARTED	173	173	0
Treatment Phase - no Optional Ofa Completed 5-year Follow-up	64	64	0
Treatment Phase - no Optional Ofa Safety Population	172	170	0
Treatment Phase - no Optional Ofa COMPLETED	95	108	0
Treatment Phase - no Optional Ofa NOT COMPLETED	78	65	0
Optional Ofa Phase STARTED	0	0	32
Optional Ofa Phase Completed 5-year Follow-up	0	0	12
Optional Ofa Phase COMPLETED	0	0	16
Optional Ofa Phase NOT COMPLETED	0	0	16

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	Optional Ofa Participants from the Benda arm who opted for optional ofatumumab therapy post disease progression.
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
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

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	Total n=346 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 61.0 • n=5 Participants	62.6 years STANDARD_DEVIATION 63.0 • n=7 Participants	62.2 years STANDARD_DEVIATION 62.0 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	71 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	102 Participants n=7 Participants	203 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	163 Participants n=5 Participants	167 Participants n=7 Participants	330 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
FLIPI-1 Score at Screening 0 - 2	100 participants n=5 Participants	93 participants n=7 Participants	193 participants n=5 Participants
FLIPI-1 Score at Screening 3 - 5	66 participants n=5 Participants	75 participants n=7 Participants	141 participants n=5 Participants
FLIPI-1 Score at Screening Missing	7 participants n=5 Participants	5 participants n=7 Participants	12 participants n=5 Participants
Baseline Absolute Lymphocyte Count (ALC) < (Lower limit of normal (LLN)	41 Participants n=5 Participants	41 Participants n=7 Participants	82 Participants n=5 Participants
Baseline Absolute Lymphocyte Count (ALC) >= LLN	131 Participants n=5 Participants	131 Participants n=7 Participants	262 Participants n=5 Participants
Baseline Absolute Lymphocyte Count (ALC) Missing	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation GG	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation TG	77 Participants n=5 Participants	59 Participants n=7 Participants	136 Participants n=5 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation TT	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Fc Gamma Receptor (FcR) Gamma 3A Variation Missing	14 Participants n=5 Participants	34 Participants n=7 Participants	48 Participants n=5 Participants
Human Anti-Chimeric Antibodies (HACA) Negative	141 Participants n=5 Participants	116 Participants n=7 Participants	257 Participants n=5 Participants
Human Anti-Chimeric Antibodies (HACA) Positive	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Human Anti-Chimeric Antibodies (HACA) Missing	11 Participants n=5 Participants	34 Participants n=7 Participants	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)	16.66 months Interval 12.81 to 19.68	13.83 months Interval 11.3 to 16.89

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC	16.62 months Interval 11.17 to 20.47	12.12 months Interval 10.94 to 16.62

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Response Rate (ORR) in All Participants Per IRC	73 Percentage of participants Interval 66.0 to 80.0	75 Percentage of participants Interval 67.0 to 81.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Response Rate (ORR) in Participants With FL Per IRC	77 Percentage of participants Interval 68.0 to 84.0	76 Percentage of participants Interval 67.0 to 83.0

SECONDARY outcome

Timeframe: From randomization up to about 89 months

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

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Survival (OS) in All Participants	59.76 months Interval 46.63 to NA = Not evaluable because of a lot of censored data	58.22 months Interval 36.44 to NA = Not evaluable because of a lot of censored data

SECONDARY outcome

Timeframe: From randomization up to about 89 months

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

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Survival (OS) in Participants With FL	NA months Interval 45.6 to NA = Not evaluable because of a lot of censored data	53.59 months Interval 36.44 to NA = Not evaluable because of a lot of censored data

SECONDARY outcome

Timeframe: From randomization to up to 67.5 months

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

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Time to Response in All Participants Per IRC	2.86 Months Interval 2.83 to 2.92	2.89 Months Interval 2.83 to 2.92

SECONDARY outcome

Timeframe: From randomization to up to 67.5 months

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

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Time to Response in Participants With FL Per IRC	2.86 Months Interval 2.83 to 2.92	2.86 Months Interval 2.83 to 2.89

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Duration of Response in All Participants Per IRC	17.71 months Interval 13.04 to 22.57	14.49 months Interval 10.84 to 16.76

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Duration of Response in Participants With FL Per IRC	16.39 months Interval 11.53 to 20.53	11.20 months Interval 8.61 to 16.43

SECONDARY outcome

Timeframe: 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.

Time from randomization until disease progression

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Time to Progression in All Participants Per IRC	19.35 Months Interval 14.32 to 23.1	16.56 Months Interval 13.63 to 19.75

SECONDARY outcome

Timeframe: 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.

Time from randomization until disease progression

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Time to Progression in Participants With FL Per IRC	19.35 Months Interval 14.16 to 24.87	13.80 Months Interval 11.14 to 16.85

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Time to Next Therapy in All Participants Per IRC	39.82 Months Interval 28.81 to NA = Not evaluable because of a lot of censored data	26.94 Months Interval 21.72 to 39.75

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Time to Next Therapy in Participants With FL Per IRC	36.96 Months Interval 23.79 to NA = Not evaluable because of a lot of censored data	25.43 Months Interval 18.37 to 47.7

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
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	-2.8 scores on a scale Standard Deviation 5.54
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	1.0 scores on a scale Standard Deviation 4.25
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	1.7 scores on a scale Standard Deviation 9.18
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	1.3 scores on a scale Standard Deviation 4.52
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	-1.5 scores on a scale Standard Deviation 6.61
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	-0.5 scores on a scale Standard Deviation 5.24
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	-1.1 scores on a scale Standard Deviation 6.45
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	-5.4 scores on a scale Standard Deviation 9.08
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	-1.3 scores on a scale Standard Deviation 4.81
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	0.3 scores on a scale Standard Deviation 3.53
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	0.1 scores on a scale Standard Deviation 4.10
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	0.7 scores on a scale Standard Deviation 3.90
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	-2.5 scores on a scale Standard Deviation 5.89
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	0.7 scores on a scale Standard Deviation 4.15
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 4.80	-2.3 scores on a scale Standard Deviation 4.12
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	-1.5 scores on a scale Standard Deviation 5.79
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	-0.6 scores on a scale Standard Deviation 5.52
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	-2.2 scores on a scale Standard Deviation 13.76
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	0.8 scores on a scale Standard Deviation 5.55
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	-1.6 scores on a scale Standard Deviation 6.47
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	-1.0 scores on a scale Standard Deviation 9.65
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	2.3 scores on a scale Standard Deviation 6.53
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	0.7 scores on a scale Standard Deviation 18.22
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	2.0 scores on a scale Standard Deviation 7.71
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	-1.6 scores on a scale Standard Deviation 7.65
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	-5.3 scores on a scale Standard Deviation 18.67
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	2.7 scores on a scale Standard Deviation 13.24
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	0.2 scores on a scale Standard Deviation 36.56
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	4.1 scores on a scale Standard Deviation 14.62
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	-4.3 scores on a scale Standard Deviation 16.77
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	-4.7 scores on a scale Standard Deviation 15.26
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 13.00	0.1 scores on a scale Standard Deviation 14.11
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	-8.4 scores on a scale Standard Deviation 31.22
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	1.5 scores on a scale Standard Deviation 13.44
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	-5.3 scores on a scale Standard Deviation 13.10
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	-5.8 scores on a scale Standard Deviation 23.05
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	2.4 scores on a scale Standard Deviation 18.73
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 30.50	-7.7 scores on a scale Standard Deviation 44.64
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	3.5 scores on a scale Standard Deviation 18.77
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	-6.5 scores on a scale Standard Deviation 18.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
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	-3.4 scores on a scale Standard Deviation 5.87
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	1.2 scores on a scale Standard Deviation 4.74
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	7.5 scores on a scale Standard Deviation 17.68
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	1.8 scores on a scale Standard Deviation 4.37
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	-0.6 scores on a scale Standard Deviation 6.31
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	-0.7 scores on a scale Standard Deviation 5.48
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	-1.4 scores on a scale Standard Deviation 5.61
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	2.5 scores on a scale Standard Deviation 3.54
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	-1.9 scores on a scale Standard Deviation 5.14
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	0.6 scores on a scale Standard Deviation 2.57
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	-0.0 scores on a scale Standard Deviation 4.41
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 4.30	0.5 scores on a scale Standard Deviation 4.10
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	-1.0 scores on a scale Standard Deviation 9.90
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	0.6 scores on a scale Standard Deviation 2.68
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	-1.9 scores on a scale Standard Deviation 4.59
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	-1.7 scores on a scale Standard Deviation 5.74
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	-0.0 scores on a scale Standard Deviation 4.84
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	7.0 scores on a scale Standard Deviation 15.56
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	1.0 scores on a scale Standard Deviation 5.75
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	-1.5 scores on a scale Standard Deviation 7.15
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	-2.2 scores on a scale Standard Deviation 9.71
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 8.70	2.4 scores on a scale Standard Deviation 6.79
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	7.0 scores on a scale Standard Deviation 38.18
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 8.00	2.2 scores on a scale Standard Deviation 6.63
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	-0.4 scores on a scale Standard Deviation 7.17
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	-7.3 scores on a scale Standard Deviation 18.77
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	3.6 scores on a scale Standard Deviation 14.01
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	21.5 scores on a scale Standard Deviation 71.42
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	4.9 scores on a scale Standard Deviation 12.32
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 15.40	-1.7 scores on a scale Standard Deviation 15.26
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 11.40	-5.8 scores on a scale Standard Deviation 16.32
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	0.2 scores on a scale Standard Deviation 13.96
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	16.0 scores on a scale Standard Deviation 39.60
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	1.4 scores on a scale Standard Deviation 11.25
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	-8.0 scores on a scale Standard Deviation 24.11
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	2.7 scores on a scale Standard Deviation 19.60
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	23.0 scores on a scale Standard Deviation 77.78
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	3.6 scores on a scale Standard Deviation 14.44
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	-3.1 scores on a scale Standard Deviation 18.48

SECONDARY outcome

Timeframe: 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.

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)

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
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 18.10	-3.8 scores on a scale Standard Deviation 19.25
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	2.7 scores on a scale Standard Deviation 18.96
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	-0.8 scores on a scale Standard Deviation 19.66
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	7.1 scores on a scale Standard Deviation 19.14
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	0.7 scores on a scale Standard Deviation 34.41
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	0.0 scores on a scale Standard Deviation 0.22
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	0.0 scores on a scale Standard Deviation 0.19
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	0.1 scores on a scale Standard Deviation 0.36
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	0.0 scores on a scale Standard Deviation 0.20
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	0.1 scores on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
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	-6.5 scores on a scale Standard Deviation 18.83
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	1.1 scores on a scale Standard Deviation 20.87
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 Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	-7.5 scores on a scale Standard Deviation 31.82
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	6.7 scores on a scale Standard Deviation 20.77
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	5.4 scores on a scale Standard Deviation 37.78
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	0.0 scores on a scale Standard Deviation 0.23
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	0.0 scores on a scale Standard Deviation 0.20
PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D EuroQoL Tariffs D252	0.0 scores on a scale Standard Deviation NA NA = Standard Deviation not available since only 1 participant was analyzed for the assessment	0.4 scores on a scale Standard Deviation 0.53
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	0.0 scores on a scale Standard Deviation 0.16
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	0.1 scores on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
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	3.8 scores on a scale Standard Deviation 2.29
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	2.5 scores on a scale Standard Deviation 1.74
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	4.8 scores on a scale Standard Deviation 2.56
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	2.6 scores on a scale Standard Deviation 1.99
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	4.3 scores on a scale Standard Deviation 2.63

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=120 Participants 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	Benda (Arm B) n=119 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
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	3.9 scores on a scale Standard Deviation 2.25
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	2.4 scores on a scale Standard Deviation 1.56
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 Standard Deviation NA NA: Not enough participants to calculate SD	4.5 scores on a scale Standard Deviation 3.54
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	2.1 scores on a scale Standard Deviation 1.54
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	4.2 scores on a scale Standard Deviation 2.96

SECONDARY outcome

Timeframe: baseline, post-baseline (up to 55 months)

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

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Reduction in Tumor Size	-33.2 mm^2 Standard Deviation 44.08	-32.8 mm^2 Standard Deviation 36.83

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status C5D1: Deteriorated	18 participants	24 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status C5D1: Improved	30 participants	22 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status C5D1: No Change	94 participants	88 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status C11D1: Deteriorated	13 participants	9 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status C11D1: Improved	27 participants	23 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status C11D1: No Change	75 participants	58 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status 12M post D252: Deteriorated	9 participants	6 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status 12M post-D252: Improved	17 participants	12 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status 12M post-D252: No Change	44 participants	38 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Withdrawal: Deteriorated	7 participants	8 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Withdrawal: Improved	2 participants	2 participants
Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Withdrawal: No Change	8 participants	11 participants

SECONDARY outcome

Timeframe: 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.

A summary by responders and non-responders

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=151 Participants 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	Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Summary of Number of Participants With Human Anti-Human Antibodies (HAHA) # of participants with post-Ofa HAHA results	151 Participants	—
Summary of Number of Participants With Human Anti-Human Antibodies (HAHA) with at least 1 conf. +ve post-Ofa HAHA result	1 Participants	—
Summary of Number of Participants With Human Anti-Human Antibodies (HAHA) -ve post-Ofa HAHA results, no Ofa conc. <200 ug/mL	6 Participants	—
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=30 Participants 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	Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine	17 Percentage of participants	—

SECONDARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=172 Participants 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	Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgA @ 12M post D252	1.1 g/L Standard Deviation 1.2	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgA @ screening (BL)	0.7 g/L Standard Deviation NA NA = SD not reached as too few participants	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgG @ screening	4.7 g/L Standard Deviation NA NA = SD not reached as too few participants	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgM @ screening	0.6 g/L Standard Deviation NA NA = SD not reached as too few participants	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgA @ C1D1	1.3 g/L Standard Deviation 0.78	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgG @ C1D1	7.7 g/L Standard Deviation 3.96	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgM @ C1D1	1.4 g/L Standard Deviation 4.15	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgA @ 1M post-D252	1.1 g/L Standard Deviation 0.74	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgG @ 1M post-D252	7.1 g/L Standard Deviation 2.90	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgM @ 1M post-D252	0.6 g/L Standard Deviation 0.68	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgA @ 6M post D252	1.1 g/L Standard Deviation 0.59	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgG @ 6M post D252	7.3 g/L Standard Deviation 2.97	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgM @ 6M post D252	0.7 g/L Standard Deviation 0.97	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgG @12M post D252	7.1 g/L Standard Deviation 3.31	—
Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM) IgM @ 12M post D252	0.7 g/L Standard Deviation 0.66	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=171 Participants 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	Benda (Arm B) Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Plasma Ofatumumab Concentrations C1D1 pre-dose	1.1 ug/mL Standard Deviation 13.97	—
Plasma Ofatumumab Concentrations C1D1 End of infusion (EOI)	262.0 ug/mL Standard Deviation 83.97	—
Plasma Ofatumumab Concentrations C1D1 1h post-EOI	283.2 ug/mL Standard Deviation 227.11	—
Plasma Ofatumumab Concentrations C7D1 pre-dose	153.6 ug/mL Standard Deviation 74.45	—
Plasma Ofatumumab Concentrations C7D1 EOI	402.2 ug/mL Standard Deviation 148.78	—
Plasma Ofatumumab Concentrations C7D1 1h post-EOI	419.1 ug/mL Standard Deviation 167.44	—
Plasma Ofatumumab Concentrations C12D1 pre-dose	143.5 ug/mL Standard Deviation 75.58	—
Plasma Ofatumumab Concentrations C12D1 EOI	392.0 ug/mL Standard Deviation 130.64	—
Plasma Ofatumumab Concentrations 12M post-D252	0.9 ug/mL Standard Deviation 2.53	—
Plasma Ofatumumab Concentrations Withdrawal	29.6 ug/mL Standard Deviation 42.58	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=173 Participants 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	Benda (Arm B) n=173 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
B-cell Monitoring (CD19+, CD20+) C5D1: CD45+CD19+	-94.0 percentage change from baseline Standard Deviation 16.6	-97.0 percentage change from baseline Standard Deviation NA NA: Not enough participants to calculate SD
B-cell Monitoring (CD19+, CD20+) 1M post-D252: CD45+CD19+	-82.0 percentage change from baseline Standard Deviation 77.0	—
B-cell Monitoring (CD19+, CD20+) 9M post-D252: CD45+CD19+	1421.0 percentage change from baseline Standard Deviation 5721.6	—
B-cell Monitoring (CD19+, CD20+) C1D1: CD45+CD20+	-100.0 percentage change from baseline Standard Deviation 0.0	-98.0 percentage change from baseline Standard Deviation NA NA: Not enough participants to calculate SD
B-cell Monitoring (CD19+, CD20+) 1M post-D252: CD45+CD20+	-100.0 percentage change from baseline Standard Deviation 0.0	—
B-cell Monitoring (CD19+, CD20+) 9M post-D252: CD45+CD20+	925.0 percentage change from baseline Standard Deviation 3803.1	—

SECONDARY outcome

Timeframe: 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

The number of participants with positive and negative baseline HACA results

Outcome measures

Outcome measures
Measure	Ofa + Benda (Arm A) n=170 Participants 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	Benda (Arm B) n=142 Participants Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Human Anti-chimeric Antibodies (HACA) Over Time Baseline: Negative	145 Participants	119 Participants
Human Anti-chimeric Antibodies (HACA) Over Time Baseline: Positive	25 Participants	23 Participants
Human Anti-chimeric Antibodies (HACA) Over Time C1D1: Negative	145 Participants	119 Participants
Human Anti-chimeric Antibodies (HACA) Over Time C1D1:Positive	25 Participants	23 Participants

Adverse Events

Ofa + Benda (Arm A)

Serious events: 72 serious events

Other events: 158 other events

Deaths: 66 deaths

Benda (Arm B)

Serious events: 84 serious events

Other events: 162 other events

Deaths: 71 deaths

Optional Ofa

Serious events: 8 serious events

Other events: 21 other events

Deaths: 15 deaths

Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa

Serious events: 160 serious events

Other events: 320 other events

Deaths: 137 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER