An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma
This is an open-label (identity of assigned study drug will be known) study of PCI-32765
(ibrutinib) in approximately 110 patients with chemoimmunotherapy-resistant FL whose disease
has relapsed from at least 2 prior lines of therapy, including at least 1 rituximab
combination chemotherapy regimen. Each patient must have resistant disease to the last
therapy (defined as progression of disease during or within 12 months of the last dose of a
CD20 antibody combination chemotherapy regimen). The study will include the following
phases: screening (up to 30 days prior to the first dose of study drug), treatment (until
disease progression or unacceptable toxicity), and posttreatment follow-up (until death,
lost to follow up, withdrawal of consent, or study end [defined as 2 years after the last
patient is enrolled]). Patients will receive 560 mg of PCI-32765 by mouth once daily on a
21-day cycle. Treatment will be continuous (without interruption) and self-administered at
home. The treatment phase will extend from administration of the first dose of study
medication until disease progression or unacceptable toxicity. Posttreatment follow-up will
extend from the end of treatment until death, lost to follow up, withdrawal of consent, or
study end. Every patient, except for those who explicitly withdraw consent from further site
contact, will be followed for survival status until the study ends. In addition, data on
subsequent antineoplastic therapy will also be collected. Serial pharmacokinetic samples
will be collected and efficacy and safety will be monitored throughout the study.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Up to 2 years after the last patient is enrolled
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Australia: Department of Health and Ageing Therapeutic Goods Administration
CR100956
NCT01779791
April 2013
September 2016
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Louisville, Kentucky 40207 | |
Kansas City, Kansas 66160 | |
Hackensack, New Jersey 07601 | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Eugene, Oregon | |
South Burlington, Vermont | |
Washington, District of Columbia |