Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
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Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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| Location | Status | Site Contact Details |
|---|---|---|
Location Stanford University School of Medicine, Stanford, California, 94305 | Status Not Available | |
Location Hackensack University Medical Center, Hackensack, New Jersey, 07601 | Status Not Available | |
Location Cll Research and Treatment Program, New Hyde Park, New York, 11042 | Status Not Available | |
Location New York Presbyterian Hospital/Cornell Medical Center, New York, New York, 94305 | Status Not Available | |
Location The Ohio Sate university, Columbus, Ohio, 43210 | Status Not Available | |
Location Oregon Health & Science University, Portland, Oregon, 97239 | Status Not Available | |
Location MD Anderson Cancer Center, Houston, Texas, 77030 | Status Not Available | |
Location University of Virginia School of Medicine Hospital, Charlottesville, Virginia, 22908 | Status Not Available | |
Location University of Wisconsin, Madison, Wisconsin, 53792 | Status Not Available |
The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
Percentage of Participants Achieving Response
Time Frame: The median follow-up time on study for all treated participants is 15.3 (range 1.9 - 22.3) months
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time Frame: From first dose of PCI-32765 to within 30 days of last dose for each participant or until study closure
PCI-32765 and Its Metabolite (PCI-45227) AUC0-24h After Repeat Dosing of PCI-32765
Time Frame: Performed During the First Month of Receiving PCI-32765
Mean Change From Baseline to Cycle 5 in EORTC QLQ-C30 Global Health Status Score
Time Frame: From Baseline to Cycle 5 (Week 20)
Interventions:
- Drug: PCI-32765
Enrollment:
115
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