An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects with Relapsed or Refractory Mantle Cell Lymphoma
Study Status
Open to Enrollment
Study Description
This clinical trial is for men and women with relapsed or refractory mantle cell lymphoma (MCL).
The purpose of the study is to provide people with relapsed/refractory MCL with early access to an experimental medication called Ibrutinib (also called PCI-32765). Early access means that Ibrutinib will be provided to people who qualify for the study prior to FDA approval. Ibrutinib is not currently FDA-approved is therefore considered an investigational drug.
Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive. All participants will receive Ibrutinib; there is no placebo.
Participants will take Ibrutinib by mouth once daily as long as they are responding to therapy and not experiencing unacceptable side effects, or until the study ends.
If ibrutinib is approved by the FDA, participants will no longer receive the drug as part of this study. If, at that time, further treatment with ibrutinib is advised by you physician, your physician will provide a prescription.
Disease Status and/or Stage
Relapsed or Refractory Mantle Cell Lymphoma
Sponsor
Janssen and Pharmacyclics
Key Eligibility
- Men and women age 18 and older
- Diagnosed with mantle cell lymphoma
- Progressive disease after prior therapy
- No prior treatment with ibrutinib
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Amelyn Rodriguez, RN
- (212) 746-1362
- [email protected]
- Weill Cornell Lymphoma Center
- (646) 962-2700
Protocol ID
PCI-32765MCL4001
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
