drugset / Trial / NCT06958705
Venetoclax as Consolidation in CLL Patients Treated With BTK Inhibitor Monotherapy
Phase 2
Recruiting
79 enrolled
The First Affiliated Hospital with Nanjing Medical University
AbbVie · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.
Timeline
- Start
- 2025-12-01
- Primary completion
- 2027-12-01
- Completion
- 2028-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Background | Acalabrutinib | Small molecule | 100 mg | Oral |
| Background | Ibrutinib | Small molecule | 420 mg | Oral |
| Background | Orelabrutinib | Small molecule | 150 mg | Oral |
| Background | Zanubrutinib | Small molecule | 160 mg | Oral |