Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 ConditioningRegimen Before Allogeneic Hematopoietic Stem Cell Transplantation for MyelodysplasticSyndrome with Moderate High IPSS-M Score
This study is a prospective, single-center, single-arm clinical study, which plans to
enroll 40 patients with high-risk myelodysplastic syndrome (MDS) to be given azacitidine
(AZA) combined with busulfan and cyclophosphamide (BUCY2) conditioning regimen to
evaluate 18-month progression-free survival (PFS), aiming to evaluate the efficacy and
safety of azacitidine plus BUCY2 pretreatment regimen.
Drug: Azacitidine Injection
On the basis of the conventional transplantation treatment regimen, combining azacitidine
injection with BUCY2 conditioning regimen (azacitidine 75 mg/m2/d for -11 days to -5
days, cytarabine 2 g/m2 q12h for -8 days to -7 days, cyclophosphamide 1.8 g/m2/d for -6
days to -5 days, busulfan 3.2 mg/kg/d for -4 days to -2 days)
Other Name: Azacitidine
Inclusion Criteria:
- Patients fully understand this study, voluntarily participate and sign the informed
consent form
- Age equal or more than 18 years old
- Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
- Patients planning to undergo allogeneic hematopoietic stem cell transplantation,
HCT-CI ≤ 3 or KPS ≥ 80%
Exclusion Criteria:
- Patients who refuse to participate in this clinical study
- Patients with central nervous system involvement
- Patients with HIV seropositive
- Patients with other serious medical conditions with a life expectancy of less than
six months
- Patients with severe psychiatric or psychological disorders
Not Provided
Xiena Cao
0086-13031186262
caoxiena@126.com
Linghui Xia, Principal Investigator
Wuhan Union Hospital, China