City of Hope Medical Center
This phase II trial tests how well nemtabrutinib works with rituximab for the treatment of patients with mantle cell lymphoma. Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers such as mantel cell lymphoma at abnormal levels. This may help keep cancer cells from growing and spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nemtabrutinib with rituximab may kill more cancer cells in patients with mantle cell lymphoma.
PRIMARY OBJECITVE: I. To evaluate the efficacy (complete response rate) of nemtabrutinib and rituximab (Nem-R) in patients with treatment-naïve mantle cell lymphoma (MCL). SECONDARY OBJECITVES: I. To evaluate objective response rate (ORR), median progression-free survival (PFS), overall survival (OS) and duration of response (DOR). II. To evaluate safety and tolerability of Nem-R in patients with treatment-naïve MCL. EXPLORATORY OBJECITVES: I. To conduct preliminary assessment of the predictive value of minimal residual disease (MRD) in MCL treated with a novel regimen. II. To explore i…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Diagnosis of MCL established by histologic assessment including one of the following: * Immunohistochemistry of the biopsy * Flow cytometry of the biopsy * Requiring treatment for MCL, and for which no prior systemic anticancer therapies have been received * Local radiotherapy not exceeding a total dose of 20 gray (Gy) at least 2 wee…
Undergo blood sample collection
Undergo bone marrow biopsy
Given PO
Undergo PET-CT scan
Given IV
Arctuva estimate
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