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A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
Trial Status: active
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.
Inclusion Criteria
Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
CLL requiring treatment as per pre-defined criteria.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
Measurable disease by CT/MRI.
Adequate marrow function.
Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
Adequate renal function.
Life expectancy > 6 months.
Signed informed consent and able to comply with the study protocol in the investigator's judgment.
Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 90 days after the last dose of study drug.
Exclusion Criteria
Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
Known central nervous system involvement
Received previous systemic treatment for CLL
Clinically significant cardiovascular disease
Severe or debilitating pulmonary disease
History of prior malignancy
Active fungal, bacterial, and/or viral infection requiring systemic therapy
Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
Unable to swallow capsules or tablets or diseases significantly affecting GI function
Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
Use of investigational agents within the last 4 weeks before screening
Pregnant and lactating females Note: Other protocol defined Inclusion/Exclusion criteria may apply
Additional locations may be listed on ClinicalTrials.gov for NCT06637501.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Status: Active
Name Not Available
Nebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
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
