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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06279338
Other study ID # [2023] No.0969
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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