Study Comparing Sonrotoclax and Zanubrutinib with Venetoclax and Obinutuzumab for Chronic Lymphocytic Leukemia (CLL)

Sponsor: BeiGene

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06073821

Provider View

This clinical trial is comparing two different treatment combinations to see which is more 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 a new combination of drugs, sonrotoclax and zanubrutinib, is more effective than the standard treatment of venetoclax and obinutuzumab for people with chronic lymphocytic leukemia (CLL). CLL is a type of blood cancer that can cause symptoms like swollen lymph nodes, night sweats, weight loss, and fever. This trial will help determine which treatment helps patients live longer without their CLL getting worse. Around 640 participants from different parts of the world will take part in this study, and they will be randomly assigned to receive one of the two treatment combinations.

Description

Chronic lymphocytic leukemia (CLL) is a blood cancer that affects many people worldwide. It can cause symptoms such as enlarged lymph nodes, night sweats, weight loss, and fever, and it often leads to a shorter life expectancy. This study is testing whether a new treatment combination, sonrotoclax plus zanubrutinib, is better than the current standard treatment, venetoclax plus obinutuzumab, for people with CLL who have not been treated before. The main goal is to compare how long patients live without their CLL getting worse between the two treatment groups. Approximately 640 participants will be involved in this study globally, and each participant will have an equal chance of receiving either treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Adults with a confirmed diagnosis of chronic lymphocytic leukemia (CLL) who have not received treatment before.
  • Good overall health with an ECOG performance status score of 0, 1, or 2, meaning fully active or with some restrictions in physical activity.
  • CLL that can be measured using imaging tests like CT or MRI scans.
  • Healthy liver function as shown by specific blood tests.
  • Healthy kidney function with a creatinine clearance of at least 50 milliliters per minute.

Exclusion Criteria

  • Have received previous treatment for CLL.
  • Have a type of leukemia called prolymphocytic leukemia or a history of Richter's transformation.
  • Have cancer that has spread to the central nervous system.
  • Have a history of a brain infection called progressive multifocal leukoencephalopathy (PML).
  • Have uncontrolled high blood pressure.

Note: Other criteria defined by the study protocol may apply.

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