Decitabine+BUCY vs BUCY Conditioning Regimen for MLL+ Acute Leukemia Undergoing Allo-HSCT

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Decitabine+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Allogeneic Hematopoietic Stem Cell Transplantation, Conditions, Mixed-lineage-leukemia (MLL)-Rearranged Acute Leukemia

Intervention / Treatment
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* Drug: Decitabine
* Drug: Busulfan (BU)
* Drug: Cyclophosphamide (CY)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MLL+ acute leukemia undergoing allo-HSCT 14-65 years Exclusion Criteria: Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decitabine + BUCY<br>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. | Drug: Decitabine<br>* Decitabine was administered at 20mg/m2/day on days -14 and -10.<br>Drug: Busulfan (BU)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>|
| Active Comparator: BUCY<br>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. | Drug: Busulfan (BU)<br>* Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.<br>Drug: Cyclophosphamide (CY)<br>* Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) |  | 2 year | 
| disease-free survival (DFS) |  | 2 year | 
| transplant-related mortality (TRM) |  | 2 year |