A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06279338

Enrollment

Registered

2024-02-28

Start date

2024-03-01

Completion date

2026-01-31

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation, Molecular International Prognostic Scoring System (IPSS-M), Azacitidine

Brief summary

Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome 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.

Interventions

DRUGAzacitidine 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)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival (PFS) at 18 months post-transplant, month	18 months post-transplantation	PFS is measured from the date of allo-HSCT to the date of relapse or death from any cause or the last follow-up for surviving patients.

Secondary

Measure	Time frame	Description
Overall survival (OS) at 18 months post-transplant, month	18 months post-transplantation	OS is defined as the time from allo-HSCT to the date of death from any cause or the last follow-up for surviving patients.

Contacts

Primary ContactXiena Cao

caoxiena@126.com0086-13031186262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026