To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.
Age ≥ 18 years old
Pathology confirmed diagnosis of mantle cell lymphoma. CD20 positivity is needed. Cyclin D1 negative MCL are allowed after confirming the diagnosis of MCL from hem-path at MDACC.
Newly diagnosed MCL with no prior therapy for MCL (age >= 18 years)
Medium risk - Ki-67% (<=50%), largest tumor size <=5 cm, no features of high-risk disease (see below in exclusion)
Participants with central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML) are excluded since those participants have very poor prognosis, need aggressive intensive chemoimmunotherapy and intrathecal chemotherapy along with BTK inhibitors and these participants would not be eligible for this study.
High risk MCL - any or all of the following (Blastoid/pleomorphic histology), High Ki-67 (>50%), Bulky disease (nodes >5 cm, spleen >20 cm), lymphocytosis >=50,000 cells/uL, TP53 mutated or del17p by FISH. Presence of MYC rearrangement positive by FISH or MYC, Bcl2 amplification, complex karyotype or high-risk biologic MIPI (with Ki-67%)
Major surgery within 4 weeks prior to registration
History of bleeding diathesis
Single group
Rituximab
DrugGiven by PO
Pirtobrutinib
DrugGiven by PO
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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