Clinical trial · Interventional
Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study
NCT05209308CI-TRIAL-00064751CORALwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Discontinuation of zandelisib development
Summary
Brief summary (as posted)
A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab | Drug | Rituximab | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
| Zandelisib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Ven "low dose" + Rituximab + Zandelisib
- interventionNames
- Drug: Zandelisib
- Drug: Rituximab
- Drug: Venetoclax
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Ven "standard dose" + Rituximab + Zandelisib
- interventionNames
- Drug: Zandelisib
- Drug: Rituximab
- Drug: Venetoclax
Primary outcomes (1)
- measure
- To determine the uMRD rate in PB and BM by flow cytometry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females ≥18 years * Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy * At least one bi-dimensionally measurable nodal lesion \>1.5 cm * Adequate renal, hepatic function * Adequate hematologic parameters at screening Exclusion Criteria: * Subjects who relapsed or progressed on BCL-2 inhibitor * Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy * History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma * History of Richter's transformation or prolymphocytic leukemia * Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure * Pregnant women
References
Publications (0)
Data not yet available
No reference posted for this study.