Description:
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.
Title
- Brief Title: A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
- Official Title: An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
BGB-3111-212
- SECONDARY ID:
2017-001552-54
- NCT ID:
NCT03332017
Conditions
- Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Zanubrutinib | BGB-3111, Brukinsa | Arm A |
Obinutuzumab | Gazyva | Arm A |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A | Experimental | Approximately 140 subjects to receive BGB-3111 and obinutuzumab | |
Arm B | Experimental | Approximately 70 subjects to receive obinutuzumab | |
Eligibility 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.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall response rate (ORR) as Assessed by Independent Central Review |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall response rate (ORR) as Assessed by the Investigator |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Complete Response Rate |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Complete Metabolic Response Rate |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | 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) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Time to response (TTR) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | |
Measure: | Occurrence and severity of treatment-emergent adverse events (TEAEs) |
Time Frame: | up to 3 years |
Safety Issue: | |
Description: | Safety and Tolerability |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
- Relapsed/Refractory Follicular non-Hodgkin Lymphoma
Last Updated
August 23, 2021