An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

• Conditions: Relapsed or Refractory Mantle Cell Lymphoma

• Registration Number: NCT01833039
• Lead Sponsor: Janssen Biotech, Inc.

Brief Summary

The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-06
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.

Exclusion Criteria

• Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible.
• Patients previously treated with ibrutinib are not eligible.
• Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified