Study on Nemtabrutinib and Rituximab for Treating Mantle Cell Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT06572618

Provider View

This clinical trial is exploring how well the combination of nemtabrutinib and rituximab works in treating patients with mantle cell lymphoma, a type of cancer affecting white blood cells. The study aims to see if this combination can effectively kill cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is testing a new treatment for mantle cell lymphoma, a cancer of the white blood cells. The treatment combines two drugs: nemtabrutinib, which blocks a protein that helps cancer cells grow, and rituximab, which helps the immune system attack cancer cells. The goal is to see if this combination can kill more cancer cells and help patients with this type of lymphoma.

Description

The main goal of this study is to see how effective the combination of nemtabrutinib and rituximab is in treating patients with newly diagnosed mantle cell lymphoma. Researchers will look at how many patients have a complete response, meaning no signs of cancer are found after treatment.

Secondary goals include evaluating how long patients live without the cancer getting worse, overall survival rates, and how long the response to treatment lasts. The study will also assess the safety and side effects of the treatment.

Exploratory goals involve studying the role of minimal residual disease, examining immune cell changes, understanding resistance to the treatment, and estimating outcomes after additional therapies if the cancer progresses.

Patients will start with an induction phase, receiving nemtabrutinib daily and rituximab weekly for the first cycle, then monthly. This phase lasts up to six cycles. If the cancer does not progress and side effects are manageable, patients will continue with a maintenance phase, receiving nemtabrutinib daily and rituximab every other month for up to 24 cycles.

Throughout the study, patients will have bone marrow biopsies, PET-CT scans, and blood tests to monitor their response to treatment. After completing the study, patients will have follow-up visits to check their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of mantle cell lymphoma (MCL) that requires treatment and have not received prior systemic cancer therapies.
  • Have good overall health with an ECOG performance status of 0 to 2.
  • Have measurable cancer based on scans.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Not have active hepatitis B or C infections, or have these infections under control.
  • If HIV positive, must have a stable condition with controlled viral load and be on a stable antiretroviral therapy.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Men capable of fathering a child must agree to use contraception during the study and for a specified time after treatment.

Exclusion Criteria

  • Use of high-dose corticosteroids or unstable heart conditions.
  • History of severe bleeding disorders or significant heart problems.
  • Active infections or recent major infections.
  • Known allergies to study drugs or similar compounds.
  • Other active cancers, except for certain treated cancers with no active disease for at least two years.
  • Pregnant or breastfeeding women.
  • Conditions that affect drug absorption, such as severe gastrointestinal issues.
  • Any other condition that may interfere with the study or pose safety concerns.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia
City of Hope at Irvine Lennar92618IrvineCalifornia

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