Clinical trial · Interventional
A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia
A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonrotoclax | Drug | — | UNRESOLVED |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Combination Therapy: Sonrotoclax + Zanubrutinib
- description
- Participants will receive sonrotoclax in combination with zanubrutinib daily for a fixed duration of 15 cycles.
- interventionNames
- Drug: Sonrotoclax
- Drug: Zanubrutinib
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Monotherapy: Zanubrutinib
- description
- Participants will receive zanubrutinib monotherapy daily until disease progression or unacceptable toxicity, whichever occurs first.
- interventionNames
- Drug: Zanubrutinib
Primary outcomes (1)
- measure
- Complete Response (CR)/ Complete Response with Incomplete Bone Marrow Recovery (CRi) Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available