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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279338
• Other study ID #: [2023] No.0969
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2024
• Source: Wuhan Union Hospital, China
• Contact: Xiena Cao
• Phone: 0086-13031186262
• Email: caoxiena[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) at 18 months post-transplant, month	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.	18 months post-transplantation
Secondary	Overall survival (OS) at 18 months post-transplant, month	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.	18 months post-transplantation