A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT06637501
Trial Phases:	Phase II	Protocol IDs:	BGB-11417-204 (primary) NCI-2024-10301 2024-513970-23-00
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	BeiGene Company Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT06637501

Summary

The purpose of this study is to support the registration plan of sonrotoclax plus
zanubrutinib treatment in participants with previously untreated CLL. This study is
designed to assess the contribution of sonrotoclax to the efficacy outcome of the
combination of zanubrutinib and sonrotoclax.

Objectives

This study will test how effective and safe sonrotoclax plus zanubrutinib treatment
compared with zanubrutinib alone in participants with previously untreated chronic
lymphocytic leukemia (CLL).

The main goals of the study are to determine how many participants may no longer have
evidence of cancer or have some improvement in the signs and symptoms of cancer after
treatment and to determine what adverse events, or side effects, patients might
experience.

Sonrotoclax is an experimental drug that works by blocking a protein called B-cell
lymphoma-2 (Bcl-2). This protein helps certain types of blood tumor cells to survive and
grow. When sonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cells and
helps them die. This can lead to improvements in patients with CLL disease.

Zanubrutinib is a commercialized product that works by blocking a protein called Bruton's
tyrosine kinase (BTK) and controlling the activity and survival of malignant B cells.
Zanubrutinib has received approval in over 65 countries/regions worldwide for the
treatment of adult participants with B cell malignancies, including CLL.

The study will enroll approximately 87 participants who will be randomly assigned by a
computer program to receive one of the following treatments: sonrotoclax + zanubrutinib
or zanubrutinib.

The study will take place at multiple centers worldwide. The overall time to participate
in this study is approximately 5 years.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.