Study on Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab for Treating Relapsed or Hard-to-Treat Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05947851

Provider View

This clinical trial is comparing two treatment combinations to see which is more effective in improving progression-free survival for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned or is difficult to treat.

Patient Parameters

Program Overview

The aim of this study is to evaluate the safety and effectiveness of a new treatment combination using nemtabrutinib and venetoclax for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or is not responding to previous treatments. Researchers want to see if this new combination is better than the current standard treatment of venetoclax and rituximab in delaying the progression of the disease.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and need treatment.
  • Have specific genetic test results available before starting the study for some participants.
  • Have tried at least one previous treatment that did not work or the disease came back.
  • Have at least one sign of the disease that can be measured.
  • Be in good general health with an ECOG performance status of 0 to 2.
  • Have a life expectancy of at least 3 months.
  • Be able to swallow pills.
  • If positive for hepatitis B, must have been treated and have no detectable virus before starting the study.
  • If previously infected with hepatitis C, must have no detectable virus at screening.
  • If living with HIV, must meet all study criteria.
  • Have good organ function based on recent tests.
  • If able to produce sperm, must agree to use effective birth control or abstain from sex during the study.
  • If female, must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.

Exclusion Criteria

  • Have an active hepatitis B or C infection.
  • Have digestive issues that affect medication absorption.
  • Have another cancer that is growing or needed treatment in the last 3 years.
  • Have a diagnosis of Richter Transformation or active brain involvement by CLL/SLL.
  • Have an active infection needing treatment during screening.
  • Have HIV with certain complications in the past year.
  • Have heart rhythm problems or significant ECG abnormalities.
  • Have allergies to study drugs or their ingredients.
  • Have a history of severe bleeding disorders.
  • Have had recent cancer treatment or certain medications before starting the study.
  • Have used certain investigational drugs or devices recently.
  • Have a psychiatric or substance use disorder affecting study participation.
  • Have not fully recovered from major surgery or have ongoing complications.

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