to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.
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.
Participants should have a life expectancy >= 12 weeks.
Newly diagnosed, untreated, high risk participant without any prior therapy for MCL and are eligible to receive BTKi-R and glofitamab therapy.
High risk MCL (Blastoid/pleomorphic histology, high Ki-67 (≥50%), TP53/NOTCH1/2, NSD2, UBR5, TRAF2, SP140, SMARCA4, KMT2D, BIRC3 mutated or any of these mutations or more than 2 mutations with some evidence of prognostic impact, complex karyotype and/or Bulky nodal disease >= 5 cm or spleen >= 20 cm, FISH positive for TP53 or MYC from involved tissues or TP53 and MYC positive intensity in lymphoma cells in involved tissues (positive by hem-path criteria at MDACC), high risk MIPI score (with/without Ki-67%). Presence of any or all of these features would qualify as high risk but will need to be reviewed and approved by the study PI.
Isolated bone marrow or GI only disease MCL participants and/or lack of any measurable disease, except if participants have leukemic phase MCL with any high risk features.
Pregnant or breast-feeding females.
Participants who are primary refractory to BTKi-R (No response/progressive disease within first 3 months of BTKi-R)
Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
Single group
Acalabrutinib
DrugGiven by po
Rituximab
DrugGiven by IV
Glofitamab
DrugGiven by IV
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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