A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.

Official Title
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An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

Conditions
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Relapsed/Refractory Follicular Non-Hodgkin Lymphoma

Intervention / Treatment
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* Drug: Zanubrutinib
* Drug: Obinutuzumab


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Histologically confirmed diagnosis of B-cell follicular lymphoma ≥2 prior systemic treatments for follicular lymphoma. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy. Disease progression after completion of most recent therapy or refractory disease. Presence of measurable disease. Availability of archival tissue confirming diagnosis. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2. Adequate renal and hepatic function. Key Exclusion Criteria: Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor. Known central nervous system involvement by leukemia or lymphoma. Evidence of transformation from follicular lymphoma to other aggressive histology. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate Clinically significant cardiovascular disease. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment. Active fungal, bacterial or viral infection requiring systemic treatment. History of severe bleeding disorder. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Approximately 140 subjects to receive BGB-3111 and obinutuzumab | Drug: Zanubrutinib<br>* BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)<br>* Other names: Brukinsa;Drug: Obinutuzumab<br>* Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.<br>* Other names: Gazyva;|
| Experimental: Arm B<br>Approximately 70 subjects to receive obinutuzumab | Drug: Obinutuzumab<br>* Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.<br>* Other names: Gazyva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) as Assessed by Independent Central Review |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) as Assessed by the Investigator |  | up to 3 years | 
| Duration of response (DOR) |  | up to 3 years | 
| Progression free survival (PFS) |  | up to 3 years | 
| Overall Survival (OS) |  | up to 3 years | 
| Complete Response Rate |  | up to 3 years | 
| Complete Metabolic Response Rate |  | up to 3 years | 
| Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |  | up to 3 years | 
| Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L) |  | up to 3 years | 
| Time to response (TTR) |  | up to 3 years | 
| Occurrence and severity of treatment-emergent adverse events (TEAEs) | Safety and Tolerability | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed/Refractory Follicular non-Hodgkin Lymphoma