M.D. Anderson Cancer Center
To learn if the combination of pirtobrutinib (also called LOXO-305) and venetoclax can help to control mantle cell lymphoma (MCL) that is relapsed (has come back) or refractory (has not responded to therapy).
PRIMARY OBJECTIVE: • To determine the efficacy (overall response rate) and safety profile of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients SECONDARY OBJECTIVE: • To evaluate the survival (including overall and progression-free survival) of the Pirtobrutinib plus venetoclax combination in relapsed refractory MCL patients. EXPLORATORY STUDIES: •Exploratory studies are planned on the trial and the final analysis and methodology including bio-informatics analysis
Inclusion Criteria: 1. Confirmed diagnosis of mantle cell lymphoma in tissue biopsy by hematopathology with/without chromosome translocation t(11;14), (q13;q32) and/or overexpress cyclin D1 in tissue biopsy. Cyclin D1 negative MCL (confirmed by hematopathology at MDACC are allowed). 2. The patient is able to take oral medications 3. Relapsed MCL (irrespective of prognostic factors) including any lines or prior therapy or patients who had prior ibrutinib, acalabrutinib, zanubrutinib, other BTK inhibitor or anti CD19-CART therapy, single agent or in combination (without prior venetoclax) or rel…
Given by PO
Given by PO
Arctuva estimate
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