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

Phase 2

Completed

• Conditions: Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
• Interventions: Drug: Obinutuzumab; Drug: Zanubrutinib

• Registration Number: NCT03332017
• Lead Sponsor: BeiGene

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2017-11-14
• Primary Completion: 2021-10-08
• Disposition First Submitted: 2023-05-24
• Disposition First Posted: 2023-05-26
• Results First Submitted: 2024-04-03
• Results First Submitted QC: 2024-04-03
• Results First Posted: 2024-04-30
• Study Completion: 2024-12-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

1. Histologically confirmed diagnosis of B-cell follicular lymphoma
2. ≥2 prior systemic treatments for follicular lymphoma.
3. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
4. Disease progression after completion of most recent therapy or refractory disease.
5. Presence of measurable disease.
6. Availability of archival tissue confirming diagnosis.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
8. Adequate renal and hepatic function.

Key

Exclusion Criteria

1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
2. Known central nervous system involvement by leukemia or lymphoma.
3. Evidence of transformation from follicular lymphoma to other aggressive histology.
4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
5. 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 cancer.
6. Clinically significant cardiovascular disease.
7. Major surgery ≤ 4 weeks prior to start of study treatment.
8. Active fungal, bacterial or viral infection requiring systemic treatment.
9. History of severe bleeding disorder.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obinutuzumab	Obinutuzumab	Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
Zanubrutinib + Obinutuzumab	Zanubrutinib	Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
Zanubrutinib + Obinutuzumab	Obinutuzumab	Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment	Through primary analysis data cut-off date of 08OCT2021 (up to approximately 3 years and 11 months)	ORR is defined as the percentage of participants who achieve either complete response (CR) or partial response (PR) as best overall response, as assessed by the IRC using Lugano Classification for Non-Hodgkin Lymphoma

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DOR)	Up to approximately 7 years
Overall Survival (OS)	Up to approximately 7 years
Overall Response Rate (ORR) as Assessed by the Investigator	Up to approximately 7 years
Complete Response Rate	Up to approximately 7 years
Complete Metabolic Response Rate	Up to approximately 7 years
Progression Free Survival (PFS)	Up to approximately 7 years
Time to Response (TTR)	Up to approximately 7 years
Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs)	Up to approximately 7 years	Safety and Tolerability
Apparent Clearance (CL/F) of Zanubrutinib	Day 1 Cycle 1 and Day 2 Cycle 2: Predose
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 approximately 7 years
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D Version (EQ-5D-5L)	Up to approximately 7 years
Area Under the Curve From 0 to 12 Hours Post Dose (AUC0-12)	Day 1 Cycle 1 and Day 2 Cycle 2: Pre-dose

Trial Locations

Locations (89)

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

University of Illinois At Chicago; 🇺🇸 Chicago, Illinois, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Canberra Hospital; 🇦🇺 Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital; 🇦🇺 Concord, New South Wales, Australia

Saint Vincents Hospital Sydney; 🇦🇺 Darlinghurst, New South Wales, Australia

Calvary Mater Newcastle; 🇦🇺 Waratah, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Icon Cancer Centre Wesley; 🇦🇺 Auchenflower, Queensland, Australia

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