A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Conditions

• Mantle Cell Lymphoma; Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• zanubrutinib — DRUG
  Administered as two 80 mg capsules by mouth twice a day
• bendamustine — DRUG
  Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
• rituximab — DRUG
  Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Study Details

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.

Key Dates

Start date

Aug 20, 2019

Status verified

May 2026

Primary completion

Mar 31, 2027

Completion

Sep 30, 2031

Study Design

Enrollment

510 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: zanubrutinib plus rituximab
  Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.
• Active Comparator: Arm B: bendamustine plus rituximab
  Participants will receive bendamustine plus rituximab, followed by observation.

Primary Outcome Measure

Progression-free survival (PFS) determined by independent central review [ Time Frame: Up to approximately 7 years ]

Locations (12)

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