Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Rituximab
  • Pirtobrutinib

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators