Clinical Trials /

Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Participants With Untreated Mantle Cell Lymphoma

NCT04002297

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.

Related Conditions:
  • Mantle Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study Comparing Zanubrutinib + Rituximab Versus Bendamustine + Rituximab in Patients 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
  • NCT ID: NCT04002297

Conditions

  • Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Interventions

DrugSynonymsArms
zanubrutinibzanubrutinib plus rituximab
bendamustinebendamustine plus rituximab
rituximabbendamustine 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 patients with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

Trial Arms

NameTypeDescriptionInterventions
zanubrutinib plus rituximabExperimental
  • zanubrutinib
  • rituximab
bendamustine plus rituximabActive Comparator
  • bendamustine
  • rituximab

Eligibility Criteria

        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

        Exclusion Criteria:

          1. Known central nervous system involvement by lymphoma

          2. Patients 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
      
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:Patient-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

  • MCL, NHL

Last Updated

October 28, 2019