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| Name | Class |
|---|---|
| Peking University People's Hospital | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
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Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. Unfortunately, some patients relapsed after allo-HSCT. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.
Recent studies have demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for TP53+ myeloid tumors, such as acute myeloid leukemia and myelodysplastic syndrome. BUCY conditioning regimen is the standard myeloablative regimen for TP53+ myeloid tumors undergoing allo-HSCT. However, it appears to have higher relapse rate and lower survival. To reduce the relapse rate and improve the survival, decitabine is added in the conditioning regimen. In this prospective randomized controlled study, the safety and efficacy of Decitabine + BUCY and BUCY myeloablative conditioning regimens in TP53+ myeloid tumors undergoing allo-HSCT are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine + BUCY | Experimental | For TP53+ myeloid tumors undergoing allo-HSCT, Decitabine +BUCY conditioning regimen was Decitabine 20mg/m2/day on days -14 and -10, Busulfan (BU) 3.2 mg/kg/day on days -7 and -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. |
|
| BUCY | Active Comparator | For TP53+ myeloid tumors undergoing allo-HSCT, BUCY conditioning regimen was Busulfan (BU) 3.2 mg/kg/day on days -7 and -4, Cyclophosphamide (CY) 60 mg/kg/day on days -3 and -2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decitabine | Drug | Decitabine was administered at 20mg/m2/day on days -14 and -10. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| relapse rate | relapse rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | overall survival (OS) | 1 year |
| disease-free survival (DFS) | disease-free survival (DFS) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifa Liu | Contact | 020-61641611 | liuqifa628@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
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| Zhujiang Hospital |
| OTHER |
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| Busulfan (BU) |
| Drug |
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4. |
|
| Cyclophosphamide (CY) | Drug | Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2. |
|
| transplant-related mortality (TRM) | transplant-related mortality (TRM) | 1 year |
| ID | Term |
|---|---|
| D000077209 | Decitabine |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| 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 |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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