A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT06637501
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
94 participants
INTERVENTIONAL
2024-11-14
2030-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib
Participants will receive sonrotoclax in combination with zanubrutinib daily for a fixed duration of 15 cycles.
Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Arm B: Monotherapy: Zanubrutinib
Participants will receive zanubrutinib monotherapy daily until disease progression or unacceptable toxicity, whichever occurs first.
Zanubrutinib
Administered orally
Interventions
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Sonrotoclax
Administered orally
Zanubrutinib
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 CT/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
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 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
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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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
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
New York Cancer and Blood Specialists
Shirley, New York, 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
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
Pratia Onkologia Katowice
Katowice, , Poland
Pratia McM Krakow
Krakow, , Poland
Uniwersytecki Szpital Kliniczny Nr W Lublinie
Lublin, , Poland
Uniwersytecki Szpital Kliniczny Hematology
Wroclaw, , Poland
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital de Cabuenes
Gijón, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Other Identifiers
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2024-513970-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-11417-204
Identifier Type: -
Identifier Source: org_study_id
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