Study on Sonrotoclax and Zanubrutinib Combination vs. Zanubrutinib Alone for Untreated Chronic Lymphocytic Leukemia

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06637501

Provider View

This clinical trial is exploring whether adding the experimental drug sonrotoclax to the approved drug zanubrutinib can improve treatment outcomes for patients with chronic lymphocytic leukemia (CLL) who have not received prior treatment.

Patient Parameters

Program Overview

The study aims to find out if combining sonrotoclax with zanubrutinib is more effective than using zanubrutinib alone in treating patients with chronic lymphocytic leukemia (CLL) who have not been treated before. Researchers want to see if this combination can help reduce or eliminate cancer signs and symptoms and to understand any potential side effects.

Description

This study is testing the effectiveness and safety of a new treatment combination for chronic lymphocytic leukemia (CLL). It compares the use of sonrotoclax plus zanubrutinib against zanubrutinib alone in patients who have not received any previous treatment for CLL.

The main goals are to see how many patients show no signs of cancer or have improvements in their cancer symptoms after treatment, and to identify any side effects they might experience.

Sonrotoclax is an experimental drug that works by blocking a protein called Bcl-2, which helps certain blood cancer cells survive and grow. By blocking Bcl-2, sonrotoclax can slow down or stop the growth of these cancer cells, potentially improving the condition of patients with CLL.

Zanubrutinib is an approved drug that blocks a protein called BTK, which controls the activity and survival of cancerous B cells. It is already used in many countries to treat B cell cancers, including CLL.

About 87 participants will be enrolled in the study and randomly assigned to receive either the combination of sonrotoclax and zanubrutinib or zanubrutinib alone. The study will be conducted at multiple centers worldwide and will last approximately 5 years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a confirmed diagnosis of chronic lymphocytic leukemia (CLL) who have not received prior treatment.
  • CLL that requires treatment based on specific criteria.
  • Good overall health with an ECOG performance status of 0, 1, or 2.
  • Cancer that can be measured by CT or MRI scans.
  • Adequate bone marrow, liver, and kidney function as shown by specific blood tests.
  • Life expectancy of more than 6 months.
  • Willingness to sign an informed consent form and follow the study protocol.
  • Women of childbearing age must agree to use effective birth control during the study and for at least 90 days after the last dose of the study drug.

Exclusion Criteria

  • Diagnosis of prolymphocytic leukemia or suspected Richter's transformation.
  • Cancer that has spread to the central nervous system.
  • Previous treatment for CLL.
  • Significant heart disease.
  • Severe lung disease.
  • History of other cancers.
  • Active infections requiring treatment.
  • Positive for HIV or active hepatitis B or C.
  • Uncontrolled autoimmune blood disorders.
  • History of severe bleeding disorders.
  • Recent stroke or brain bleeding.
  • Difficulty swallowing pills or significant digestive issues.
  • Allergic reactions to zanubrutinib, sonrotoclax, or their ingredients.
  • Use of experimental drugs within 4 weeks before the study.
  • Pregnant or breastfeeding women.

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