Study on the Safety and Effectiveness of Nemtabrutinib for Blood Cancers

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04728893

Provider View

This clinical trial is testing a new drug, nemtabrutinib, to see if it is safe and effective for treating various blood cancers, including chronic lymphocytic leukemia, small lymphocytic lymphoma, and others.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective the drug nemtabrutinib is for treating different types of blood cancers, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and others. The study is divided into two parts: the first part determines the best dose, and the second part tests the drug in specific groups of patients with these cancers.

Description

This study is conducted in two phases. In the first phase, researchers will determine the best dose of nemtabrutinib. In the second phase, the study will expand to include different groups of patients with specific types of blood cancers. These groups include patients with CLL/SLL, Richter's transformation, marginal zone lymphoma, mantle cell lymphoma, follicular lymphoma, and Waldenström's macroglobulinemia. The study aims to see if nemtabrutinib can help manage these conditions effectively and safely.

Eligibility Criteria

Inclusion Criteria

  • Must be able to perform daily activities with minimal assistance (ECOG score 0-2).
  • Expected to live at least 3 more months.
  • Able to swallow pills.
  • If positive for Hepatitis B, must have been treated and have no detectable virus.
  • If previously infected with Hepatitis C, must have no detectable virus.
  • Must have good organ function.
  • Men must agree not to donate sperm and use birth control during the study.
  • Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
  • HIV-positive participants must have a stable condition with controlled virus levels.
  • Specific criteria for different cancer types, such as having received certain prior treatments or having specific genetic markers.

Exclusion Criteria

  • Active Hepatitis B or C infection.
  • History of another cancer within the last 3 years, except for certain skin cancers or early-stage prostate cancer.
  • Active disease in the central nervous system.
  • Active infection requiring treatment.
  • Recent treatment with other cancer therapies or participation in another clinical trial.
  • Significant digestive issues that affect medication absorption.
  • History of severe bleeding disorders.

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