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

Not Applicable

Not yet recruiting

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: Azacitidine Injection

• Registration Number: NCT06279338
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacitidine	Azacitidine Injection	Combining azacitidine with classic BUCY2 regimen as conditioning regimen

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.