NCT05564052

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

A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician's Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants With Relapsed or Refractory Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Mantle cell lymphoma (MCL) is an uncommon and incurable clinicopathologic subtype of B-cell non-Hodgkin Lymphoma (NHL). Ibrutinib is a first-in-class potent, orally administered, covalently-binding small molecule inhibitor of Bruton's tyrosine kinase (BTKi) for the treatment of B-cell malignancies and chronic graft-versus-host disease. The primary hypothesis of the study is to provide continued access to treatment for participants who continue to benefit from treatment. The study will include a screening phase (up to 30 days prior to randomization), a treatment phase (from randomization until study treatment discontinuation). safety assessments include adverse events (AEs), serious adverse events (SAEs), clinical laboratory tests, vital signs, electrocardiogram (ECG), physical examination. The Phase 2 exploratory objectives and endpoints of characterization of pharmacokinetic and pharmacodynamic of ibrutinib may continue to be evaluated using blood samples already collected. The total duration of the study will be up to 2 years 1 month.

Conditions

• Lymphoma, Mantle-Cell

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib capsules will be administered orally.
DRUG	Lenalidomide	Lenalidomide capsules will be administered orally.
DRUG	Rituximab	Rituximab will be administered IV.
DRUG	Bortezomib	Bortezomib will be administered either intravenously or subcutaneously.

Timeline

• Start date: 2022-12-06
• Primary completion: 2023-12-06
• Completion: 2024-09-26
• First posted: 2022-10-03
• Last updated: 2025-10-07
• Results posted: 2025-01-13

Locations

66 sites across 13 countries: Brazil, Czechia, Greece, India, Malaysia, Poland, Puerto Rico, Romania, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study