An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Recruiting in Palo Alto (17 mi)
+61 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Janssen Biotech, Inc.
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Research Team
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.
Treatment Details
Interventions
- Ibrutinib (Bruton's Tyrosine Kinase Inhibitor)
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Imbruvica for:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
🇺🇸 Approved in United States as Imbruvica for:
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
🇨🇦 Approved in Canada as Imbruvica for:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
🇯🇵 Approved in Japan as Imbruvica for:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01833039Denver, CO
NCT01833039Baltimore, MD
NCT01833039Norwalk, CT
NCT01833039Chicago, IL
More Trial Locations
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Who Is Running the Clinical Trial?
Janssen Biotech, Inc.
Lead Sponsor
Trials
30
Patients Recruited
18,800+
Pharmacyclics LLC.
Industry Sponsor
Trials
114
Patients Recruited
13,800+