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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azacitidine | Experimental | Combining azacitidine with classic BUCY2 regimen as conditioning regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azacitidine Injection | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiena Cao | Contact | 0086-13031186262 | caoxiena@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Linghui Xia | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
|
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |