City of Hope Medical Center
This phase II trial tests the effect of nemtabrutinib in combination with rituximab in treating patients with marginal zone lymphoma. Nemtabrutinib, a non-covalent Bruton's tyrosine kinase (BTK) inhibitor, may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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 in combination with rituximab may be safe, tolerable and/or effective in treating patients with marginal zone lymphoma.
PRIMARY OBJECTIVES: I. To evaluate safety and tolerability of nemtabrutinib administered in combination with rituximab (NR) in patients with marginal zone lymphoma (MZL). (Safety lead-in) II. To evaluate efficacy of nemtabrutinib administered in combination with rituximab (NR) in patients with MZL based on complete response rate. (Phase 2) SECONDARY OBJECTIVE: I. To evaluate efficacy of nemtabrutinib administered in combination with rituximab in patients with MZL based on overall response rate (ORR), progression free survival, duration of response, and overall survival. EXPLORATORY OBJECTI…
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 MZL including splenic marginal zone lymphoma (SMZL), extra nodal marginal zone lymphoma (ENMZL) and nodal marginal zone lymphoma (NMZL), established by histologic assessment * Requiring treatment for MZL. Patients receiving prior systemic therapy as well as treatment naïve patients are eligible * Local radiotherapy not exceedi…
Undergo tissue biopsy
Undergo blood sample collection
Undergo bone marrow biopsy
Undergo CT or PET/CT
Undergo MRI
Given PO
Undergo PET/CT
Given IV
Arctuva estimate
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