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| Name | Class |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | OTHER |
| Guangzhou First People's Hospital | OTHER |
| Peking University People's Hospital | OTHER |
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Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. 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 MLL+ acute leukemia undergoing allo-HSCT are evaluated.
Recent studies demonstrated that allogeneic hematopoietic stem cell transplantation (allo-HSCT) could be a valuable treatment choice for mixed-lineage-leukemia (MLL)-rearranged acute leukemia. BUCY conditioning regimen is the standard myeloablative regimen for MLL+ acute leukemia 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 MLL+ acute leukemia undergoing allo-HSCT are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decitabine + BUCY | Experimental | For MLL+ acute leukemia 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 MLL+ acute leukemia 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 | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 2 year | |
| disease-free survival (DFS) | 2 year | |
| transplant-related mortality (TRM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifa Liu | Contact | liuqifa628@163.com | ||
| Qifa Liu | Contact |
| 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 |
| Third Affiliated Hospital, Sun Yat-Sen University | 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. |
|
| 2 year |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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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