The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed 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. An interim analysis of the pharmacokinetic data will occur approximately 3 months after the scheduled pharmacokinetic sampling in Cycles 1 and 2 has been completed. Data will be analyzed 1 year after the last patient is enrolled for the primary analysis and 2 years after last patient is enrolled for the final follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Type=exact number, unit=mg, number=560, form=capsule, route=oral use. 560 mg oral ibrutinib is to be administered once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug.
Overall response rate
Time frame: 1 year after the last patient is enrolled
Overall survival rate
Time frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled
Progression-free survival rate
Time frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled
Mean change from baseline in the Lym subscale
Time frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled
Mean change from baseline in the EQ-5D-5L index
Time frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled
Mean plasma concentrations of ibrutinib
Time frame: Up to Cycle 2, Day 21
Maximum observed plasma concentration of ibrutinib
Time frame: Up to Cycle 2, Day 21
Minimum observed plasma concentration of ibrutinib
Time frame: Up to Cycle 2, Day 21
Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib
Time frame: Up to Cycle 2, Day 21
The number of participants affected by an adverse event
Time frame: Up to 30 days after the last dose of study medication
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Unnamed facility
La Jolla, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Norwalk, Connecticut, United States
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Jacksonville, Florida, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Goshen, Indiana, United States
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Iowa City, Iowa, United States
Unnamed facility
Sioux City, Iowa, United States
...and 46 more locations
Overall response rate
Time frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled