Phase 2 Study of BGB-16673 and Sonrotoclax for Untreated Chronic Lymphocytic Leukemia (CLL)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07508995

Provider View

This clinical trial is testing a new combination of drugs, BGB-16673 and Sonrotoclax, to see if they are safe and effective for people with Chronic Lymphocytic Leukemia (CLL) who have not received treatment before.

Patient Parameters

Program Overview

The study aims to find out if the combination of BGB-16673 and Sonrotoclax can effectively treat CLL by reducing the amount of cancer cells to undetectable levels. It will also look at how long patients stay free from cancer progression, their overall survival, and how safe and tolerable the treatment is. Researchers will also study changes in the immune system and cancer cells in response to the treatment.

Description

This trial is focused on patients with Chronic Lymphocytic Leukemia (CLL) who have not been treated before. The main goal is to see if the combination of two drugs, BGB-16673 and Sonrotoclax, can effectively reduce cancer cells to undetectable levels. The study will also measure how long patients remain free from cancer progression, their overall survival, and the safety of the treatment. Researchers will also explore how the treatment affects the immune system and cancer cells over time. Participants will need to meet certain health criteria and agree to follow the study's procedures, including taking the medication as directed and attending regular check-ups.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) and meet specific treatment criteria.
  • Age 18 years or older.
  • Good overall health with a performance status score of 0 to 2.
  • Adequate liver and kidney function based on specific blood tests.
  • Adequate blood cell counts, including platelets, hemoglobin, and neutrophils.
  • Ability to swallow tablets and follow the study's treatment plan.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study.
  • Men must agree to use effective birth control during the study.
  • Willingness to sign an informed consent document.

Exclusion Criteria

  • Recent major surgery within 4 weeks before starting the study.
  • Active, uncontrolled infections or certain viral infections like HIV or hepatitis.
  • Uncontrolled autoimmune conditions requiring high-dose steroids.
  • Significant heart disease or uncontrolled high blood pressure.
  • History of certain heart rhythm problems without a pacemaker.
  • Pregnant or breastfeeding women.
  • Use of certain medications that interact with the study drugs.
  • Consumption of grapefruit or certain fruits that affect drug absorption.
  • Active second cancer unless in remission and not requiring treatment.
  • History of allergic reactions to similar drugs.
  • Conditions affecting drug absorption in the stomach or intestines.
  • Recent live-virus vaccinations.
  • History of bleeding disorders or recent strokes.
  • Known transformation of CLL to a more aggressive form.
  • Psychiatric or social conditions affecting study compliance.
  • Participation in other investigational drug studies.

Locations

FACILITYZIPCITYSTATE
UT MD Anderson77030HoustonTexas

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