drugset / Trial / NCT06660368
BCL2i CLAG-M in R/R Acute Myeloid Leukemia
RandomizedParallel-groupOpen-labelTreatment
Summary
This multicenter, open-label phase II study combines CLAG-based therapy with or without venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) in order to improve measurable residual disease (MRD) clearance and event-free survival. Investigators hypothesize that the addition of venetoclax to CLAG-M in patients with relapsed or refractory AML is safe, and superior to CLAG-M alone in improving patient outcomes.
Timeline
- Start
- 2024-11-26
- Primary completion
- 2027-11
- Completion
- 2027-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Mitoxantrone | Small molecule | 16 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 300 ug | — |