A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

Conditions

• Lymphoma, Mantle-Cell

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Ibrutinib capsules will be administered orally.
• Lenalidomide — DRUG
  Lenalidomide capsules will be administered orally.
• Rituximab — DRUG
  Rituximab will be administered IV.
• Bortezomib — DRUG
  Bortezomib will be administered either intravenously or subcutaneously.

Study Details

The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.

Key Dates

Start date

Dec 6, 2022

Status verified

Sep 2025

Primary completion

Dec 6, 2023

Completion

Sep 26, 2024

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2: Treatment Arm A1 (Rituximab plus Ibrutinib)
  Participants will receive rituximab 375 milligrams per meter square (mg/m\^2) intravenously (IV) on Day 1 of Cycles 1 to 6 with ibrutinib 560 milligrams (mg) orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
• Experimental: Phase 2: Treatment Arm A2 (Rituximab plus Ibrutinib)
  Participants will receive rituximab 375 mg/m\^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 420 mg orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
• Experimental: Phase 2: Treatment Arm A3 (Rituximab plus Ibrutinib)
  Participants will receive rituximab 375 mg/m\^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 140 mg orally, twice daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
• Experimental: Phase 2: Treatment Arm B (Rituximab plus Lenalidomide or Bortezomib)
  Participants will receive rituximab 375 mg/m\^2 IV on Day 1 of Cycles 1 to 6 (each cycle length is 21 or 28 days) with physician's choice of either lenalidomide 20 mg orally, once daily from Day 1 through Day 21 of 28-day cycle or bortezomib 1.3 mg/m\^2 IV or subcutaneously (SC) on Days 1, 4, 8 and 11 of a 21-day cycle until disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B [ Time Frame: From start of treatment (Day 1) up to 30 days after last dose of study drug or start of subsequent anticancer therapy, whichever occurred first (up to 12 months) ]