A Phase II Study of the Non-Covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab in Patients With Marginal Zone Lymphoma
City of Hope Medical Center
Summary
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.
Description
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…