A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Conditions

• Marginal Zone Lymphoma
• Relapsed/Refractory Follicular Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanubrutinib — DRUG
  Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
• Rituximab — DRUG
  Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
• Lenalidomide — DRUG
  Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
• Obinutuzumab — DRUG
  Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.

Study Details

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.

Key Dates

Start date

Mar 10, 2022

Status verified

Jun 2026

Primary completion

Jul 31, 2028

Completion

Jun 30, 2030

Study Design

Enrollment

780 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab
  Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
• Active Comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
  Participants will receive lenalidomide and rituximab.
• Experimental: Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab
  Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
• Active Comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
  Participants will receive lenalidomide and rituximab.

Primary Outcome Measure

Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC) [ Time Frame: Approximately 78 months ]

Central Contacts

• Study Director BeOne Medicines
  1-877-828-5568
  [email protected]

Locations (49)

Find similar trials in Fresno, CA

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