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Trial Title:
A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score
NCT ID:
NCT06279338
Condition:
Myelodysplastic Syndromes
Conditions: Official terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome
Azacitidine
Conditions: Keywords:
Allogeneic Hematopoietic Stem Cell Transplantation
Molecular International Prognostic Scoring System (IPSS-M)
Azacitidine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Azacitidine Injection
Description:
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)
Arm group label:
Azacitidine
Other name:
Azacitidine
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2024
Completion date:
January 31, 2026
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279338
