Study Comparing Nemtabrutinib with Ibrutinib or Acalabrutinib for First-Time Treatment of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06136559

Provider View

This clinical trial is testing a new drug, nemtabrutinib, against two existing treatments, ibrutinib and acalabrutinib, in patients with CLL or SLL who have not received any previous treatment. The study aims to see if nemtabrutinib is as effective or better in controlling the disease and preventing it from getting worse.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of nemtabrutinib with the doctor's choice of either ibrutinib or acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not been treated before. Researchers want to find out if nemtabrutinib works as well as or better than the other two drugs in terms of how well it helps patients and how long it keeps the disease from progressing.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of CLL or SLL and active disease that needs treatment.
  • At least one sign of disease burden.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Ability to swallow and keep down oral medication.
  • If positive for hepatitis B, must have been on antiviral therapy for at least 4 weeks 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 other eligibility criteria.

Exclusion Criteria

  • Active hepatitis B or C infection.
  • Digestive issues that could affect drug absorption.
  • Diagnosis of Richter Transformation or active brain involvement by CLL/SLL.
  • Recent serious infections related to AIDS.
  • Significant heart disease.
  • Allergic to nemtabrutinib or cannot take ibrutinib or acalabrutinib.
  • History of severe bleeding disorders.
  • History of another cancer unless treated and cancer-free for 2 years.
  • Previous treatment for CLL/SLL.
  • Currently taking certain medications that affect drug processing in the body.
  • Recent radiotherapy or related side effects needing steroids.
  • Recent live vaccines.
  • Recent use of experimental drugs or devices.
  • Immune system issues or taking high-dose steroids or other immune-suppressing drugs.
  • Active autoimmune disease needing treatment in the past 2 years.
  • Active infection needing treatment.
  • Not fully recovered from major surgery or have ongoing surgical issues.

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