An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Sponsor: Janssen Biotech, Inc.
Expanded Access
Approved for Marketing
Sponsor score: 40
ClinicalTrials ID:NCT01833039
This study provides early access to ibrutinib for patients with relapsed or refractory Mantle Cell Lymphoma. Eligible participants are adults who have not previously received ibrutinib and are not part of other ibrutinib trials. The trial aims to gather safety data on ibrutinib, an investigational drug.
Patient Parameters
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Program Overview
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.
Eligibility 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.
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