drugset / Trial / NCT03235973
Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes
NaSingle-groupOpen-labelTreatment
Summary
The investigators focused on patients with refractory acute leukemia or MDS and designed a phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided myeloablative busulfan doses. This scheme allows combining different optimization of RTC experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine analog cladribine) to approach a specific platform to treat refractory diseases.
Timeline
- Start
- 2018-04-28
- Primary completion
- 2020-04
- Completion
- 2021-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cladribine | Small molecule | 10 mg/m2 | — |
| Subject | Cladribine | Small molecule | 15 mg/m2 | — |
| Subject | Cladribine | Small molecule | 20 mg/m2 | — |
| Subject | Cladribine | Small molecule | 25 mg/m2 | — |
| Background | Busulfan | Small molecule | 100 mg/m2 | Intravenous |
| Background | Busulfan | Small molecule | 130 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 10 mg/m2 | — |