Overview

Decitabine Plus mBU/CY Preconditioning for Relapse/Refractory Acute Leukemia

Status:
Recruiting

Trial end date:
2023-12-31

Target enrollment:
0

Participant gender:
All

Summary

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) remains one of the currently available curative therapies for acute leukemia (AL). Leukemia relapse is one of the mainly causes of transplant failure. We reported previously that patients with relapse or refractory AL were at very high risk of relapse post allo-HSCT, with cumulative relapse rate of 50-80%. Decitabine has been demonstrated efficacy in the treatment of patients with recurrent or refractory leukemia and myelodysplastic syndrome. It was reported that the combination of decitabine, with busulfan and cyclophosphamide as a preparative regimen for allo-HSCT using HLA-matching donors was safe and effective. In this prospective, single-arm clinical trial, we aimed to examine the efficacy of combining decitabine with modified busulfan and cyclophosphamide (mBU/CY) as a preparative regimen for allo-HSCT in recurrent and refractory AL patients.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Peking University People's Hospital

Treatments:

Azacitidine
Busulfan
Cyclophosphamide
Decitabine
Semustine

Criteria

Inclusion Criteria:

- patients with relapsed acute leukemia

- patients with acute leukemia in the third（or more）complete remission (CR3) status

Exclusion Criteria:

- pregnancy women

- uncontrolled severe infection