Overview

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

Status:
Approved for marketing
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Biotech, Inc.
Collaborator:
Pharmacyclics LLC.
Criteria
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.