Trial Outcomes & Findings for An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma (NCT NCT03817853)

Last Updated: 2024-04-04

Results Overview

IRRs were defined as all adverse events (AEs) that occurred during or within 24 hours from the end of study treatment infusion and were judged as related to infusion of study treatment components by the investigator.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

114 participants

Primary outcome timeframe

Within 24 hours from the end of study treatment infusion of Day 1 in Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)

Results posted on

2024-04-04

Participant Flow

Participants were enrolled at 35 sites across 7 countries.

Of the all participants population (114 participants), one participant did not receive the study treatment, thus the safety-evaluable population included 113 participants.

Participant milestones

Participant milestones
Measure	All Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Induction Phase STARTED	113	0	0
Induction Phase COMPLETED	93	0	0
Induction Phase NOT COMPLETED	20	0	0
Maintenance Phase STARTED	0	95	0
Maintenance Phase COMPLETED	0	67	0
Maintenance Phase NOT COMPLETED	0	28	0
Follow-up Phase STARTED	0	0	99
Follow-up Phase COMPLETED	0	0	92
Follow-up Phase NOT COMPLETED	0	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Induction Phase Adverse Event	5	0	0
Induction Phase Measures due to covid19; transformation to double hit high-grade b lymphoma; discontinuation of trt.	3	0	0
Induction Phase Physician Decision	2	0	0
Induction Phase Progressive Disease	6	0	0
Induction Phase Withdrawal by Subject	4	0	0
Maintenance Phase Adverse Event	0	8	0
Maintenance Phase Death	0	5	0
Maintenance Phase Progressive Disease	0	7	0
Maintenance Phase Withdrawal by Subject	0	2	0
Maintenance Phase Physician Decision	0	1	0
Maintenance Phase Various reasons	0	4	0
Maintenance Phase Protocol Deviation	0	1	0
Follow-up Phase Adverse Event	0	0	2
Follow-up Phase Death	0	0	1
Follow-up Phase Progressive Disease	0	0	3
Follow-up Phase Withdrawal by Subject	0	0	1

Baseline Characteristics

An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.
Age, Continuous	58.9 Years STANDARD_DEVIATION 12.7 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants
Race/Ethnicity, Customized Asian	27 Participants n=5 Participants
Race/Ethnicity, Customized White	82 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	33 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 24 hours from the end of study treatment infusion of Day 1 in Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)

Population: The Short Duration Infusion (SDI) population included all enrolled particpants who did not experience a Grade 3 or 4 IRR during cycle 1 (i.e. at any of the three Cycle 1 infusions), received obinutuzumab given at the standard rate only during Cycle 1, and received obinutuzumab as an SDI at cycle 2.

Outcome measures

Outcome measures
Measure	All Participants n=99 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Percentage of Grade >=3 Infusion-Related Reactions (IRRs) During Cycle 2 in Patients Who Had Previously Received Obinutuzumab at the Standard Infusion Rate During Cycle 1 Without Experiencing a Grade 3 or 4 IRR	0 Percentage of Participants Interval 0.0 to 3.66	—	—

SECONDARY outcome

Timeframe: Baseline up to end of study (approximately 4 years)

Population: The safety population included all participants who received at least one dose of obinutuzumab.

An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsened during the study, recurrence of an intermittent medical condition, deterioration in a laboratory value or other clinical test or were related to a protocol-mandated intervention were also considered AEs. Grading was completed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab n=95 Participants Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up n=99 Participants Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Percentage of Participants With Adverse Events (AEs)	99.1 Percentage of Participants	90.5 Percentage of Participants	27.3 Percentage of Participants

SECONDARY outcome

Timeframe: Within 24 hours from the end of study treatment infusion in all cycles, including maintenance ((1 cycle: 21 or 28 days depending on the chemotherapy selected); up to approximately 2.5 years)

Population: The safety population included all participants who received at least one dose of obinutuzumab.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Percentage of IRRs Regardless of Grade by Cycle Cycle 1 Day 1	50.4 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 1 Day 2	7.8 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 1 Day 8	5.4 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 1 Day 15	4.5 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 2	11.8 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 3	8.3 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 4	6.5 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 5	5.6 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 6	4.8 Percentage of Participants	—	—
Percentage of IRRs Regardless of Grade by Cycle Cycle 7	3.6 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: From infusion to onset of IRR during Cycle 2 (1 cycle: 21 or 28 days depending on the chemotherapy selected)

Population: The SDI population included all enrolled participants who did not experience a Grade 3 or 4 IRR during cycle 1 (i.e. at any of the three Cycle 1 infusions), received obinutuzumab given at the standard rate only during Cycle 1, and received obinutuzumab as an SDI at cycle 2. For this outcome measure, only one participant was analyzed.

Time to IRR (of any grade) in Cycle 2 was defined as the time from the start of infusion (i.e., start date/time of infusion of the first component of study treatment) in Cycle 2 to the onset of the IRR (of any grade) during Cycle 2.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Time to IRR From Infusion to Onset of the IRR During Cycle 2	11.800 Hours Standard Deviation NA Standard deviation (SD) is not available because only 1 participant had the time to IRR recorded and the SD for one value is not defined.	—	—

SECONDARY outcome

Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

Population: The safety population included all participants who received at least one dose of obinutuzumab.

The duration of obinutuzumab administration (in minutes) by cycle was defined as the difference between the end time and the start time of obinutuzumab administration.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Duration (In Minutes) of Obinutuzumab Administration by Cycle Cycle(C) 1 Day(D) 1	295.96 Minutes Standard Deviation 147.87	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C1D8	215.97 Minutes Standard Deviation 46.99	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C1D15	208.91 Minutes Standard Deviation 33.13	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C2	99.61 Minutes Standard Deviation 13.36	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C3	103.29 Minutes Standard Deviation 65.45	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C4	99.26 Minutes Standard Deviation 13.90	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C5	98.46 Minutes Standard Deviation 16.48	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C6	99.10 Minutes Standard Deviation 12.18	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C7	98.84 Minutes Standard Deviation 13.61	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle C8	95.68 Minutes Standard Deviation 4.12	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 1	97.64 Minutes Standard Deviation 10.08	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 9	96.78 Minutes Standard Deviation 8.49	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 17	97.77 Minutes Standard Deviation 7.66	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 25	97.16 Minutes Standard Deviation 7.23	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 33	95.08 Minutes Standard Deviation 4.27	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 41	95.77 Minutes Standard Deviation 5.26	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 49	93.56 Minutes Standard Deviation 4.48	—	—
Duration (In Minutes) of Obinutuzumab Administration by Cycle Maintenance Week 57	93.50 Minutes Standard Deviation 4.95	—	—

SECONDARY outcome

Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

Population: The safety population included all participants who received at least one dose of obinutuzumab. Only 1 participant had a Grade \>=3 IRR, with 3 symptoms in Cycle 5. Weight increased was a grade 1 symptom belonging to the grade 3 IRRs.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle C5 - Renal failure	33.3 Percentage of Participants	—	—
Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle Cycle (C) 5- Hypertension	33.3 Percentage of Participants	—	—
Type of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle C5 - Weight increased	33.3 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: All cycles including maintenance (1 cycle: 21 or 28 days depending on the chemotherapy selected; up to approximately 2.5 years)

Population: The safety population (113 participants) included all participants who received at least one dose of obinutuzumab.

The duration, in minutes, of IRRs during all cycles, where obinutuzumab was administered as an SDI.

Outcome measures

Outcome measures
Measure	All Participants n=1 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Duration of Grade >=3 IRRs Associated With the Obinutuzumab Administered as an SDI by Cycle	165.0 Minutes Standard Deviation NA SD is not available because only 1 participant had the duration of IRR recorded and the SD for one value is not defined.	—	—

SECONDARY outcome

Timeframe: Baseline up to end of induction therapy (up to approximately 6 months)

Population: The safety population included all participants who received at least one dose of obinutuzumab.

ORR at EOI therapy was defined as the percentage of particpants with either a CR, CR unconfirmed or PR at the EOI visit, as determined by the investigator and according to the guidelines used at the site.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Objective Response Rate (ORR) at the End of Induction (EOI) Therapy Complete Response	68.1 Percentage of Participants	—	—
Objective Response Rate (ORR) at the End of Induction (EOI) Therapy Partial Response	19.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Baseline up to end of study (up to approximately 4 years)

Population: The safety population included all participants who received at least one dose of obinutuzumab.

PFS was defined as the time from start of treatment to the first occurrence of disease progression as assessed by the investigator according to the guidelines used at the site or death from any cause.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Progression-Free Survival (PFS) Rate at the End of the Study	33.97 Months Interval 32.13 to Due to the low number of events, the upper CI limit was not evaluable.	—	—

SECONDARY outcome

Timeframe: Baseline up to end of study (up to approximately 4 years)

Population: The safety population included all participants who received at least one dose of obinutuzumab.

OS was defined as the time from start of treatment (date of first intake of any study treatment component) to death from any cause.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Overall Survival (OS) at the End of the Study	NA Months Interval 33.97 to The median could not be estimated due to the low number of events.	—	—

SECONDARY outcome

Timeframe: Baseline up to 30 months

Population: The safety population included all participants who received at least one dose of obinutuzumab.

The CR30 rate was defined as the percentage of participants with a CR at 30 months from study treatment initiation (date of first intake of any study treatment component), as determined by the investigator according to the guidelines used at the site.

Outcome measures

Outcome measures
Measure	All Participants n=113 Participants Participants were enrolled in an induction phase and received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant.	Maintenance: Obinutuzumab Participants received 6-8 cycles of obinutuzumab, combined with 6 or 8 cycles of standard chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone/methylprednisolone \[CHOP - 21-day cycle) or bendamustine (28-day cycle), or cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone \[CVP - 21-day cycle\]). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. The investigator was free to choose the chemotherapy for each participant. Participants who achieved a partial response (PR) or complete response (CR) following the induction phase received obinutuzumab maintenance therapy. 1000 mg of obinutuzumab as single agent was administered as an SDI every 8 weeks (+ or - 10 days) for 2 years or until disease progression).	Follow-up Participants with stable disease (SD) or progressive disease (PD) as best response after induction therapy discontinued study treatment and underwent a safety follow-up visit at 3 months (90 days (+ or - 10 days)). All participants were followed up at 3 months (90 days (+ or - 10 days)) from the time of the last dose of study treatment.
Complete Response (CR) Rate at 30 Months (CR30), as Assessed by the Investigator and According to the Guidelines Used at the Site	55.6 Percentage of Participants Interval 45.68 to 65.12	—	—

Adverse Events

All Participants

Serious events: 21 serious events

Other events: 111 other events

Deaths: 9 deaths

Maintenance

Serious events: 17 serious events

Other events: 76 other events

Deaths: 8 deaths

Follow-up

Serious events: 11 serious events

Other events: 13 other events

Deaths: 4 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER