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

• Status: Not yet recruiting
• Trial end date: 2033-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the recommended dosage of ibrutinib when administered in combination with rituximab in participants with relapsed or refractory (r/r) mantle cell lymphoma (MCL) (Phase 2); and to compare the progression-free survival (PFS) of ibrutinib plus rituximab versus physician's choice of lenalidomide plus rituximab or bortezomib plus rituximab (Phase 3).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: Pharmacyclics LLC.
• Treatments: Bortezomib; Lenalidomide; Rituximab

Criteria

Inclusion Criteria:

• At least 1 prior treatment regimen for mantle cell lymphoma (MCL) excluding inhibitor of Bruton's tyrosine kinase (BTKi)

• Documented disease progression or relapse following the last anti-MCL treatment

• At least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (CT)

• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:

• Prior therapy with ibrutinib or other BTK inhibitor

• Prior treatment with both lenalidomide and bortezomib. Prior treatment with only 1 of these therapies is allowed

• Major surgery within 4 weeks of randomization

• Concurrent enrollment in another therapeutic investigational study

• Known central nervous system lymphoma

• History of stroke or intracranial hemorrhage within 6 months prior to randomization