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

Running, not enrolling · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

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.

Key facts

Study ID

NCT06637501

Run by

BeOne Medicines

People needed

94

Starts

2024-11-14

Expected to finish

2029-09-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 computed tomography (CT)/magnetic resonance imaging (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.

You may not qualify if…

• 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 human immunodeficiency virus (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

Where it is running

• 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
• Utah Cancer Specialists Cancer Center — Salt Lake City, Utah, United States
• 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, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• The First Peoples Hospital of Changzhou — Changzhou, Jiangsu, China
• Jiangsu Province Hospital — Nanjing, Jiangsu, China
• Rui Jin Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• 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

Full record on ClinicalTrials.gov

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