Study on Nemtabrutinib and Rituximab for Treating Marginal Zone Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT07583810

Provider View

This clinical trial is exploring the effects of combining two drugs, nemtabrutinib and rituximab, to treat patients with marginal zone lymphoma, a type of cancer affecting certain white blood cells. The study aims to determine if this combination is safe and effective in reducing cancer growth.

Patient Parameters

Program Overview

This phase II study is testing a new treatment for marginal zone lymphoma, a type of cancer that affects certain white blood cells. The treatment combines two drugs: nemtabrutinib, which blocks enzymes that help cancer cells grow, and rituximab, which helps the immune system target cancer cells. Researchers want to see if this combination is safe and effective in treating patients with this type of lymphoma.

Description

The main goals of this study are to assess the safety and effectiveness of the drug combination of nemtabrutinib and rituximab in patients with marginal zone lymphoma (MZL). The study will look at how well the treatment works by measuring the complete response rate, which indicates how many patients experience a full reduction of cancer signs.

Patients will take nemtabrutinib by mouth daily and receive rituximab through an IV on specific days over several cycles. Each cycle lasts 28 days, and patients can continue treatment for up to 12 cycles if the cancer does not progress or cause severe side effects. If patients respond well, they may continue taking nemtabrutinib for an additional 12 cycles.

Throughout the study, patients will have regular blood tests and imaging scans to monitor their health and the treatment's effects. Optional procedures like bone marrow and tissue biopsies may also be conducted. After completing the treatment, patients will have follow-up visits to track their progress and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of marginal zone lymphoma (MZL), including specific subtypes like splenic, extranodal, or nodal MZL.
  • Need treatment for MZL, whether previously treated or not.
  • Have measurable cancer or specific conditions related to MZL.
  • Be willing to provide a tissue sample for analysis.
  • Meet certain health criteria, including blood counts and organ function.
  • Agree to use effective contraception if of childbearing potential.
  • Have a life expectancy of more than 3 months.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have a different type of aggressive lymphoma.
  • Have a history of central nervous system lymphoma or certain other diseases.
  • Have had a recent stem cell transplant or other cancer treatments.
  • Have uncontrolled health conditions or infections.
  • Be pregnant or breastfeeding.
  • Have a history of severe allergic reactions to study drugs.
  • Have significant heart or lung conditions.
  • Be unable to comply with study procedures.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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