drugset / Trial / NCT05870995
Chemotherapy CLAGE-Ven Sequential With Reduced Intensity Conditioning for Refractory Acute Myelodi Leukemia
NaSingle-groupOpen-labelTreatment
Summary
The investigators developed a protocol combining chemotherapy of cladribine, cytarabine and etoposide (CLAGE) as debulking treatment sequential with reduced intensity conditioning regimen Flu-Bu to treat patients with refractory acute myeloid leukemia (AML). In this study, the aim is to further evaluate the efficacy and feasibility of the protocol with modifications: 1) reduced dose of CLAGE; 2) Reduced intensity conditioning (RIC) regimen as fludarabine, busulfan and melphalan (MBF) or total marrow irradiation (TMI); 3) Venetoclax was added to the chemotherapy and conditioning regimen.
Timeline
- Start
- 2023-02-01
- Primary completion
- 2026-02-01
- Completion
- 2026-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Cladribine | Small molecule | 5 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 1 g | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |
| Subject | Melphalan | Small molecule | 50 mg/m2 | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |