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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Jiangsu University | OTHER |
| Xuzhou Medical University | OTHER |
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The purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
Allo-HSCT is the most effective treatment stratagey for high risk acute myeloid leukemia. At present, modified BUCY is the standard conditioning regimen for AML undergoing allo-HSCT in our institute. However, relapse occured in as high as 30-50% high risk AML patients after allo-HSCT. Thus, the best conditioning regimen for this subgroup remains to be optimized. Low dose decitabine in combination with chemotherapy have been shown to improve comple remission rate of high risk AML patients. To reduce the relapse rate after allo-HSCT, low dose decitabine is added in the modified BUCY regimen. In this study, the safety and efficacy of low dose decitabine + modified BUCY vs modified BUCY myeloablative conditioning regimens in high risk undergoing allo-HSCT are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine plus Modified BUCY | Experimental | For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide. |
|
| Modified BUCY | Active Comparator | For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine plus Modified BUCY | Drug | Decitabine:20 mg/m²/day on day -14 to -10; Modified BUCY:
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival (DFS) | time from randomization to the first of reccurrence or death | 3 year |
| overall survival (OS) | time from randomization to death from any cause | 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| veno-occlusive disease (VOD) | incidence of veno-occlusive disease (VOD) events | 3 year |
| graft-versus-host disease (GvHD) | incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Tang, MD | Contact | +86-512-67781851 | xwtang1020@163.com | |
| Depei Wu, MD | Contact | +86-512-67781851 | wudepei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Depei Wu, MD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| Southeast University, China |
| OTHER |
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|
| Modified BUCY | Drug |
|
|
| 3 year |
| transplant related mortality (TRM) | cumulative incidence of transplant related mortality | 3 year |
| relapse | cumulative incidence of relapse | 3 year |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077209 | Decitabine |
| ID | Term |
|---|---|
| D001374 | Azacitidine |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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