Official Title
A Clinical Study of Azacitidine Combined With BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome With Moderate High IPSS-M Score
Brief Summary

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

Detailed Description

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.

Not yet recruiting
Myelodysplastic Syndromes

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

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Contacts

Xiena Cao
0086-13031186262
caoxiena@126.com

Linghui Xia, Principal Investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT Number
Keywords
Allogeneic Hematopoietic Stem Cell Transplantation
Molecular International Prognostic Scoring System (IPSS-M)
Azacitidine
MeSH Terms
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine