drugset / Trial / NCT05766514
Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase II, open-label, randomized trial will compare the efficacy of the novel regimen of cladribine/low-dose cytarabine alternating with decitabine to the current standard of care regimen of hypomethylating agents (decitabine or azacitidine) plus venetoclax in patients with acute myeloid leukemia (AML) or high-grade myelodysplastic syndrome (MDS) who are either elderly or unfit for intensive induction. Subjects will be randomized to be treated with either cladribine/low-dose cytarabine alternating with decitabine (Arm A) or decitabine or azacitadine plus venetoclax (Arm B).
Timeline
- Start
- 2025-04
- Primary completion
- 2029-12
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 20 mg | Subcutaneous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Comparator | Venetoclax | Small molecule | 400 mg | Oral |