A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy
This is a single-arm (all patients will receive the study drug) study to evaluate the
efficacy and safety of ibrutinib in patients with mantle cell lymphoma (MCL) who have
received at least 1 rituximab-containing chemotherapy regimen and who progressed after
bortezomib therapy. Approximately 110 eligible patients will be enrolled. During the
treatment phase, patients will receive 560 mg of ibrutinib by mouth once daily continuously
until disease progression, unacceptable toxicity, or study end, whichever occurs first.
Treatment will be continuous (without interruption) and self-administered at home. Doses can
be held or reduced based on the severity of and the recovery from side effects of the study
drug. The sponsor will ensure that patients benefiting from treatment with ibrutinib will be
able to continue treatment after the end of the study. Data will be collected on disease
response to the treatment, on progression-free survival, overall survival, and subsequent
anti-MCL therapies. Serial pharmacokinetic (study of what the body does to a drug) samples
will be collected as detailed in the protocol. Safety will be monitored throughout the
study. Data will be analyzed 6 months after the last patient is enrolled for the primary
analysis and 2 years after last patient is enrolled for the final follow-up.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
6 months after the last patient is enrolled
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100847
NCT01599949
August 2012
March 2015
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
New Britain, Connecticut 06052 | |
Bettendorf, Iowa 52722 | |
Alexandria, Minnesota 56308 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Columbia, Missouri 65203 | |
Albany, New York 12208 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
McLean, Virginia 22101 | |
Kansas City, Kansas 66160 | |
Omaha, Nebraska 68114 | |
Hackensack, New Jersey 07601 | |
Metairie, Louisiana 70006 | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
South Burlington, Vermont | |
Milwaukee, Wisconsin | |
Indianapolis, Indiana | |
Charleston, West Virginia 25304 | |
Sioux Falls, South Dakota |