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

Janssen (J&J Innovative Medicine)

Status

Conditions: Relapsed or Refractory Mantle Cell Lymphoma

Treatments: Drug: Ibrutinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01833039

CR101862

PCI-32765MCL4001 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.