M.D. Anderson Cancer Center
to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.
Primary Objective To determine the rate of minimal residual disease (MRD) negativity following treatment with 12 cycles of glofitamab in participants with high risk MCL after achieving CR on standard first line treatment with BTKi (Acalabrutinib or Zanubrutinib)-rituximab Secondary Objectives To determine overall response rate (ORR), complete response (CR), Early MRD negative response, progression-free survival (PFS), overall survival (OS), and evaluate the safety of glofitamab as consolidation treatment for MCL
Eligibility Criteria Participants must meet the following criteria for study entry: 1. Confirmed diagnosis of mantle cell lymphoma by hematopathology. MCL should have CD20 positivity (by flow or IHC in tissue or in BM) with presence of chromosome translocation t (11;14), (q13;q32) and/or overexpression of cyclin D1 in tissue biopsy. Cyclin D negative MCL are allowed after discussion with study PI. 2. Participants should have a life expectancy \>= 12 weeks. 3. Newly diagnosed, untreated, high risk participant without any prior therapy for MCL and are eligible to receive BTKi-R and glofitamab…
Given by po
Given by IV
Given by IV
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