This is a phase II study to evaluate the efficacy of ibrutinib in combination with bortezomib in in MCL (mantle cell lymphoma) patients who relapsed on single agent ibrutinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m\^2 on days 1, 4, 8, and 11 of each 21-day cycle.
Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle.
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
The proportion of participants that respond to treatment at 6 months
The primary endpoint is overall response rate (ORR). Participants will be evaluated for response based on the Lugano criteria.
Time frame: 6 Months
Overall survival time
Patients will be followed for survival until death or up to 10 years.
Time frame: Up to 10 Years
Progression free survival time
Progression will be determined using the Lugano criteria. Patients will be followed for survival until death or up to 10 years.
Time frame: Up to 10 Years
Best overall response
Participants will be evaluated for response based on the Lugano criteria. From the start of the study treatment until the disease progression/recurrence or up to 10 years.
Time frame: Up to 10 Years
Rate of complete response
Participants will be evaluated for response based on the Lugano criteria. The percentage of participants who achieve CR after treatment.
Time frame: Up to 10 Years
Time to progression
Progression will be determined using the Lugano criteria.
Time frame: Up to 10 Years
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