drugset / Trial / NCT07588594
Thiotepa-Containing Conditioning Regimen for Allogeneic HSCT in Chronic Myelomonocytic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective, single-arm clinical study. It aims to evaluate the effectiveness and safety of a conditioning regimen containing thiotepa (in combination with busulfan and fludarabine, with or without ATG) of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with chronic myelomonocytic leukemia (CMML) who have an intermediate-2 or high-risk prognosis. The main goal is to evaluate 1 year RFS and OS. Other goals include assessing engraftment, overall survival, transplant-related complications, and side effects. A total of 31 participants will be enrolled.
Timeline
- Start
- 2026-02-13
- Primary completion
- 2028-05
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ATG | Unknown | 1.125 mg/kg | — |
| Subject | ATG | Unknown | 2.5 mg/kg | — |
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |
| Subject | Thiotepa | Other / unclassified | 5 mg/kg | Intravenous |
| Background | CsA | Unknown | — | — |
| Background | MMF | Unknown | — | — |
| Background | MTX | Unknown | — | — |