A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
2. CLL requiring treatment as per pre-defined criteria.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1, or 2.
4. Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI).
5. Adequate marrow function.
6. Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
7. Adequate renal function.
8. Life expectancy \> 6 months.
9. Signed informed consent and able to comply with the study protocol in the investigator's judgment.
10. 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:
1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
2. Known central nervous system involvement
3. Received previous systemic treatment for CLL
4. Clinically significant cardiovascular disease
5. Severe or debilitating pulmonary disease
6. History of prior malignancy
7. Active fungal, bacterial, and/or viral infection requiring systemic therapy
8. Positive human immunodeficiency virus (HIV) serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
9. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
10. 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
11. History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
12. Unable to swallow capsules or tablets or diseases significantly affecting GI function
13. Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
14. Use of investigational agents within the last 4 weeks before screening
15. Pregnant and lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Primary outcome measure(s)
Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate — Month 16 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
Trial sites (32)
Facility
City
Region
Status
Cleveland Clinic Florida
Weston
Florida
Northwest Georgia Oncology Centers Marietta
Marietta
Georgia
Illinois Cancer Specialists (Niles) Usor
Niles
Illinois
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore
Maryland
Nebraska Cancer Specialists (Satellite Site)
Omaha
Nebraska
Nebraska Cancer Specialists
Omaha
Nebraska
University of Nebraska Medical Center
Omaha
Nebraska
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene
Oregon
Texas Oncology Dfw
Dallas
Texas
Texas Oncology Tyler
Tyler
Texas
Utah Cancer Specialists Cancer Center
Salt Lake City
Utah
Centro de Pesquisas Oncologicas Cepon
Florianópolis
Brazil
Hospital de Clinicas de Porto Alegre
Porto AlegreRS
Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo
Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo
Brazil
Fujian Medical University Union Hospital
Fuzhou
Fujian
Henan Cancer Hospital
Zhengzhou
Henan
The First Peoples Hospital of Changzhou
Changzhou
Jiangsu
Jiangsu Province Hospital
Nanjing
Jiangsu
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia
Italy
Aou Careggi, Servizio Sanitario Toscana
Florence
Italy
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena
Italy
Aoor Villa Sofia Cervello
Palermo
Italy
Pratia Onkologia Katowice
Katowice
Poland
Pratia McM Krakow
Krakow
Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin
Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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