Description:
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab
versus bendamustine plus rituximab in previously untreated participants with mantle cell
lymphoma (MCL) who are not eligible for stem cell transplantation.
Title
- Brief Title: Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma
- Official Title: A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
Clinical Trial IDs
- ORG STUDY ID:
BGB-3111-306
- SECONDARY ID:
2019-000413-36
- NCT ID:
NCT04002297
Conditions
- Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
zanubrutinib | BGB-3111, Brukinsa | zanubrutinib plus rituximab |
bendamustine | | bendamustine plus rituximab |
rituximab | | bendamustine plus rituximab |
Purpose
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab
versus bendamustine plus rituximab in previously untreated participants with mantle cell
lymphoma (MCL) who are not eligible for stem cell transplantation.
Trial Arms
Name | Type | Description | Interventions |
---|
zanubrutinib plus rituximab | Experimental | | |
bendamustine plus rituximab | Active Comparator | | |
Eligibility Criteria
Key Inclusion Criteria:
1. ≥ 70 years of age at the time of informed consent, OR 65-69 years of age with
comorbidities precluding autologous stem cell transplantation
2. Histologically confirmed diagnosis of MCL
3. No prior systemic treatments for MCL
4. Measurable disease by CT/MRI
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
6. Adequate marrow and organ function
Key Exclusion Criteria:
1. Known central nervous system involvement by lymphoma
2. Participants for whom the goal of therapy is tumor debulking prior to stem cell
transplant
3. Clinically significant cardiovascular disease
4. History of severe bleeding disorder
5. Unable to swallow capsules or disease significantly affecting gastrointestinal
function
6. Active fungal, bacterial and/or viral infection requiring systemic therapy
7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 65 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival (PFS) determined by independent central review |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | PFS by investigator |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Overall response rate (ORR) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Participant-reported outcomes (PROs) as assessed by the EQ-5D-5L questionnaire |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | PROs as assessed by the EORTC QLQ-C30 questionnaire |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Measure: | Occurrence and severity of treatment-emergent adverse events (safety and tolerability) |
Time Frame: | Up to 7 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | BeiGene |
Trial Keywords
Last Updated
June 22, 2021