GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma
Trial Parameters
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Brief Summary
Primary Objectives: To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old. 2. Confirmed pathology diagnosis of MCL with t(11;14)(q13;q32) translocation and/or cyclin D1 overexpression (e.g., positive immunohistochemistry staining). 3. MCL cells are CD20 positive (e.g., positive staining on immunohistochemistry or flow cytometry). 4. No prior MCL-directed systemic treatment (such as chemotherapy, immunotherapy, targeted therapy, and cellular therapy) or radiotherapy. NOTE: A short course of corticosteroids (e.g., ≤ 1 week of intravenous or ≤ 2 weeks of oral) given for acute MCL-related symptoms or impending severe organ dysfunction is allowed, but a washout period of 3 days is required before registration. 5. Have a clinical indication to treat (e.g., B symptoms, or symptomatic or progressive lymphadenopathy or hepatosplenomegaly, or cytopenia caused by MCL, etc.). 6. ECOG performance status (PS) 0-2 (Appendix I). 7. Evaluable disease, i.e., ANY of the following: * Measurable lymph node or extranodal lesion with at le