Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
NCT Number: NCT06572618
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Mantle Cell Lymphoma
Interventions: PROCEDURE: Biospecimen Collection|PROCEDURE: Bone Marrow Biopsy|DRUG: Nemtabrutinib|PROCEDURE: Positron Emission Tomography and Computed Tomography Scan|BIOLOGICAL: Rituximab
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 27
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2025-02-11
Completion Date: 2026-02-19
Locations: City of Hope Medical Center, Duarte, California, 91010, United States|City of Hope at Irvine Lennar, Irvine, California, 92618, United States

Summary:
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 Outcome Measures: Complete response rate, Defined as the proportion of response-evaluable participants that achieve a best response of complete response (CR) at any time on the study prior to any disease progression or start of other anti-lymphoma therapy. Will be estimated among response-evaluable participants along with the 95% exact binomial confidence interval., Up to 5.5 years
Secondary Outcome Measures: Overall response rate, Defined as the proportion of response-evaluable participants that achieve a best response of either CR or partial response (PR) any time on the study prior to any disease progression or start of other anti-lymphoma therapy. Will be estimated among response-evaluable participants along with the 95% exact binomial confidence interval., Up to 5.5 years|Progression free survival, Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation., From start of protocol treatment to disease relapse/progression, start of other anti-lymphoma therapy, or death due to any cause, whichever occurs earlier, up to 5.5 years|Overall survival, Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation., From start of protocol treatment to death due to any cause, up to 5.5 years|Duration of response, Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation., From the first achievement of PR or CR to time of progressive disease, start of non-protocol anti-lymphoma therapy, or death, whichever earlier, up to 5.5 years|Incidence of adverse events, Toxicities/adverse events will be recorded and severity assessment will be the National Cancer Institute Common Terminology Criteria for Adverse Events 5.0 scale. Toxicities will be summarized by time of onset, type, severity, and attribution., Up to 5.5 years