Trial Outcomes & Findings for Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy (NCT NCT03113422)

NCT ID: NCT03113422

Last Updated: 2025-05-23

Results Overview

CR assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 56 participants
• Primary outcome timeframe: After 6 cycles (at 28 days/cycle) of induction therapy.
• Results posted on: 2025-05-23

Participant Flow

Between December 2017 and November 2020, 56 eligible and treated patients were enrolled.

Patients were directly assigned to receive induction therapy.

Participant milestones

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Venetoclax, Obinutuzumab and Bendamustine in High Tumor Burden Follicular Lymphoma as Front Line Therapy

Baseline characteristics by cohort

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants
Ann-Arbor Stage Stage II	2 Participants n=5 Participants
Ann-Arbor Stage Stage III	16 Participants n=5 Participants
Ann-Arbor Stage Stage IV	38 Participants n=5 Participants
FLIPI-1 Risk Factors 0	1 Participants n=5 Participants
FLIPI-1 Risk Factors 1	3 Participants n=5 Participants
FLIPI-1 Risk Factors 2	20 Participants n=5 Participants
FLIPI-1 Risk Factors 3	24 Participants n=5 Participants
FLIPI-1 Risk Factors 4	8 Participants n=5 Participants
FLIPI-2 Risk Factors 0	2 Participants n=5 Participants
FLIPI-2 Risk Factors 1	8 Participants n=5 Participants
FLIPI-2 Risk Factors 2	19 Participants n=5 Participants
FLIPI-2 Risk Factors 3	21 Participants n=5 Participants
FLIPI-2 Risk Factors 4	6 Participants n=5 Participants
GELF Risk Factors 0	2 Participants n=5 Participants
GELF Risk Factors 1	22 Participants n=5 Participants
GELF Risk Factors 2	15 Participants n=5 Participants
GELF Risk Factors 3	12 Participants n=5 Participants
GELF Risk Factors 4	4 Participants n=5 Participants
GELF Risk Factors 5	1 Participants n=5 Participants
WHO Disease Stage Grade 1	10 Participants n=5 Participants
WHO Disease Stage Grade 2	32 Participants n=5 Participants
WHO Disease Stage Grade 3A	9 Participants n=5 Participants
WHO Disease Stage Missing	5 Participants n=5 Participants
ECOG Performance Status 0	35 Participants n=5 Participants
ECOG Performance Status 1	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 6 cycles (at 28 days/cycle) of induction therapy.

CR assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Complete Response (CR) at End of Induction Complete Response (CR)	41 Participants
Complete Response (CR) at End of Induction Partial Response (PR)	11 Participants
Complete Response (CR) at End of Induction Stable Disease (SD)	1 Participants
Complete Response (CR) at End of Induction Progressive Disease (PD)	0 Participants
Complete Response (CR) at End of Induction Unevaluable	3 Participants

SECONDARY outcome

Timeframe: After 6 cycles (at 28 days/cycle) of induction therapy

ORR assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Overall Response Rate (ORR) Yes, Objective Response (CR+PR)	52 Participants
Overall Response Rate (ORR) No, Objective Response (SD+PD+UN)	4 Participants

SECONDARY outcome

Timeframe: Up to 24 cycles which corresponds to 22 months (at 28 days/cycle)

Conversion to CR during Maintenance Therapy assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=11 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Convert to CR During Maintenance Therapy (From PR in Induction) Complete Response (CR)	4 Participants
Convert to CR During Maintenance Therapy (From PR in Induction) Partial Response (PR)	3 Participants
Convert to CR During Maintenance Therapy (From PR in Induction) Unevaluable	4 Participants

SECONDARY outcome

Timeframe: Up to 24 months

PFS assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Progression-Free Survival (PFS) in the Intent to Treat (ITT) Population.	87.5 2-year PFS (% of participants) Interval 75.3 to 93.9

SECONDARY outcome

Timeframe: Up to 24 months

OS assessed in accordance with Lymphoma Response Criteria (Lugano Criteria)

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Overall Survival (OS) in the ITT Population.	94.6 2-year OS (% of participants) Interval 86.7 to 97.9

SECONDARY outcome

Timeframe: Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months.

Number of participants with abnormal laboratory values and/or adverse events related to treatment of GRADE 3 or higher

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Number of Participants With Treatment-related GRADE 3+ Adverse Events as Assessed by CTCAE V4.0	47 Participants

SECONDARY outcome

Timeframe: Up to 6 cycles (at 28 days/cycle)

Off treatment Reasons

Outcome measures

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 Participants Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Patient Compliance in Receiving Induction Therapy Disease progression	1 Participants
Patient Compliance in Receiving Induction Therapy Treatment completed	34 Participants
Patient Compliance in Receiving Induction Therapy Adverse events	12 Participants
Patient Compliance in Receiving Induction Therapy Death	1 Participants
Patient Compliance in Receiving Induction Therapy Investigator discontinued treatment	5 Participants
Patient Compliance in Receiving Induction Therapy Patient withdrawal	2 Participants
Patient Compliance in Receiving Induction Therapy More than 28 days of treatment interruption	1 Participants

Adverse Events

Obinutuzumab + Bendamustine + Venetoclax Induction

Serious events: 31 serious events

Other events: 46 other events

Deaths: 3 deaths

Serious adverse events

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 participants at risk Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Investigations Tumor lysis syndrome	14.3% 8/56 • Number of events 8 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
General disorders Back pain	3.6% 2/56 • Number of events 5 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Blood and lymphatic system disorders Neutropenia	3.6% 2/56 • Number of events 5 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
General disorders Nausea	7.1% 4/56 • Number of events 4 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
General disorders Pyrexia	7.1% 4/56 • Number of events 4 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Respiratory, thoracic and mediastinal disorders Lung infection	5.4% 3/56 • Number of events 3 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Gastrointestinal disorders Vomitting	5.4% 3/56 • Number of events 3 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Skin and subcutaneous tissue disorders Cellulitis	3.6% 2/56 • Number of events 2 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
General disorders Infusion related reaction	3.6% 2/56 • Number of events 2 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.8% 1/56 • Number of events 1 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.

Other adverse events

Measure	Obinutuzumab + Bendamustine + Venetoclax Induction n=56 participants at risk Cycle 1-6: Obinutuzumab 1000mg intravenously (IV) Cycle 1-6: Bendamustine 90 mg/m² IV Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10
Gastrointestinal disorders Nausea	82.1% 46/56 • Number of events 46 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
General disorders Fatigue	60.7% 34/56 • Number of events 34 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Gastrointestinal disorders Vomitting	46.4% 26/56 • Number of events 26 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Gastrointestinal disorders Diarrhea	42.9% 24/56 • Number of events 24 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Blood and lymphatic system disorders Thrombocytopenia	41.1% 23/56 • Number of events 23 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Blood and lymphatic system disorders Neutropenia	37.5% 21/56 • Number of events 21 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
General disorders Headache	28.6% 16/56 • Number of events 16 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Gastrointestinal disorders Decreased appetite	26.8% 15/56 • Number of events 15 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Blood and lymphatic system disorders Anemia	21.4% 12/56 • Number of events 12 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Blood and lymphatic system disorders Infusion related reaction	19.6% 11/56 • Number of events 11 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Renal and urinary disorders Hyperuricemia	17.9% 10/56 • Number of events 10 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Hepatobiliary disorders AST/ALT increase	17.9% 10/56 • Number of events 10 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.
Gastrointestinal disorders Constipation	17.9% 10/56 • Number of events 10 • Adverse events were captured through 6 cycles of therapy (at 28 days/cycle) and for 30 days after the last dose, for a total assessment period of approximately 7 months. Patients were followed for survival for up to 24 months.

Additional Information

Mr Opeyemi Jegede

Dana-Farber Cancer Institute

Phone: (617) 582-7613

Email: ojegede@jimmy.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place