The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL). This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.
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. Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Administered orally
Administered orally
Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate
Best CR/CRi rate per the Independent Review Committee (IRC) response assessment using the 2018 International Workshop on Chronic Lymphocytic Leukemia guidelines with modification for treatment-related lymphocytosis for participants with CLL
Time frame: Month 16
Undetectable Minimal Residual Disease at < 10^-4Sensitivity (uMRD4) Rate
uMRD4 rate measured in both peripheral blood and bone marrow aspirate
Time frame: Month 16
CR/CRi Rate per Investigator Response Assessment
CR/CRi Rate (CRR) is defined as the percentage of participants with best overall response of CR or CRi
Time frame: Month 16
Overall Response Rate (ORR) per IRC and Investigator Response Assessment
ORR is defined as the percentage of participants achieving overall response (CR+CRi+partial response \[PR\]+nodular PR) per the IRC and the investigator response assessment.
Time frame: Up to 66 Months
Duration of Response (DOR) per Investigator Response Assessment
DOR is defined as the time from first qualifying response (PR, nodular PR, CR,or CRi) until CLL progression or death.
Time frame: Up to 66 Months
Time to Response (TTR) per IRC and Investigator Response Assessment
TTR is defined as the time from treatment initiation to the first documentation of response
Time frame: Up to 66 Months
Landmark Progression-free Survival Rate at 24 Months per Investigator Assessment
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Cleveland Clinic Florida
Weston, Florida, United States
Northwest Georgia Oncology Centers Marietta
Marietta, Georgia, United States
Illinois Cancer Specialists (Niles) Usor
Niles, Illinois, United States
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Nebraska Cancer Specialists (Satellite Site)
Omaha, Nebraska, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Texas Oncology Dfw
Dallas, Texas, United States
Texas Oncology Tyler
Tyler, Texas, United States
...and 22 more locations
The 24-month landmark PFS rate is defined as the percentage of participants who remain alive and progression-free at 24 months since the start of treatment
Time frame: 24 Months
Progression-free Survival (PFS) per Investigator Response Assessment
PFS is defined as the time from the start of treatment to the first documentation of disease progression or death, whichever occurs first
Time frame: Up to 66 Months
Overall Survival (OS)
OS is defined as the time from treatment initiation to death due to any cause
Time frame: Up to 66 Months
Number of Participants with Adverse Events (AEs)
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Time frame: From first dose of study drug to 30 days after last dose; up to 66 months for Arm A and Arm B