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

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Obinutuzumab; Zanubrutinib

Criteria

Key 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

6. Clinically significant cardiovascular disease.

7. Major surgery or significant injury ≤ 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.