Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objectives * To determine the efficacy measured by ORR (CR + PR) at the end of cycle 3 of combination of PR (Pirtobrutinib plus rituximab) in MCL patients with low and intermediate risk. * To determine the safety profile of Pirtobrutinib with rituximab combination in MCL participants with low and intermediate risk. Secondary Objectives * To evaluate the CR, best overall response (OR: CR + PR), progression-free and overall survival from PR combination in MCL. * To assess MRD negative CR rates
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: The study will enroll 50 previously untreated low and medium risk MCL patients. Estimated 3 patients per month at minimum for enrollment. 1. Age ≥ 18 years old 2. 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. 3. Newly diagnosed MCL with no prior therapy for MCL (age \>= 18 years) • Low risk - Ki-67% (\<= 30%), no features of high-risk disease (see below in exclusion), largest tumor size \<= 3 cm. * Medium risk - Ki-67% (\<=50%), large…
Interventions
- DrugRituximab
Given by PO
- DrugPirtobrutinib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas