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Clinical Trials in China / NCT06637501
Active, not recruiting Phase 2

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

NCT06637501 · tracked via the Priya Life Science China tracker
Sponsor
BeOne Medicines
Phase
Phase 2
Started
2024-11-14
Last updated
2026-07-09

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

SonrotoclaxZanubrutinib

Sonrotoclax: Administered orally

Zanubrutinib: Administered orally

Study summary

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)

Trial sites (32)

FacilityCityRegionStatus
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 Wroclaw Poland
Hospital Clinic de Barcelona Barcelona Spain
Hospital de Cabuenes Gijón Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain

On this site

📄 Brukinsa (zanubrutinib) drug profile →

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Official registry record

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.

View NCT06637501 on ClinicalTrials.gov ↗ ← All trials in China