Clinical trial · Interventional
Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia
NCT06073821CI-TRIAL-00121054active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
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 |
|---|---|---|---|
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Sonrotoclax | Drug | — | UNRESOLVED |
| Venetoclax | Drug | Venetoclax | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sonrotoclax Plus Zanubrutinib
- description
- Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)
- interventionNames
- Drug: Sonrotoclax
- Drug: Zanubrutinib
- type
- ACTIVE_COMPARATOR
- label
- Venetoclax Plus Obinutuzumab
- description
- Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)
- interventionNames
- Drug: Venetoclax
- Drug: Obinutuzumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment * Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2 * Measurable disease by Computer Tomography/Magnetic Resonance Imaging * Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN * Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute Exclusion Criteria: * Previous systemic treatment for CLL * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation * Known central nervous system involvement * History of confirmed progressive multifocal leukoencephalopathy (PML) * Uncontrolled hypertension Note: Other protocol defined criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.