Flu-Bu-Mel Conditioning Regimen for Myeloid Disease

Study Overview
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Brief Summary
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For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be 5-day Fludarabine, 2-day Busulifan and 2-day melphalan

Detailed Description
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For patients with acute myeloid leukemia (AML) or myelodyspasia syndrome undergoing allo-HSCT, the conditioning regimen will be Fludarabine (30mg/m2, d-7 to d-3) + Busulifan 3.2mg/kg (d-7 to d-6) + melphalan 70mg/m2 (d-4 and d-3). The GVHD prophylaxis will be PT-CY (Cyclophosphamide 50mg/kg d+3 and d+4) + low-dose ATG (2.5mg/kg) on d+15.

Official Title
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Phase II Study ofFlu-Bu-Mel Conditioning Regimen for Patients With Myeloid Disease Undergoing Allogeneic Stem Cell Transplantation

Conditions
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Relapse Rate After Allo-HSCT

Intervention / Treatment
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* Drug: Flu-Bu-Mel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute myeloid leukemia (CR1 or CR2) or myelodysplasia syndrome patients with HLA matched sibling, unrelated or Haplo-identical donor Exclusion Criteria: patients with active infection patients with abnormal liver function damage: ALT/AST above 2X normal range patients with abnormal renal function damage Scr>160µmol/L; patients with insufficient pulmonary function (FEV1，FVC，DLCO<50%）and heart failure or with EF <50%) patients with mental instability or unwilling to give inform consent

Ages Eligible for Study
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Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flu-Bu-Mel<br>Fludarabine 150mg/m2 + Busulfan 3.2mg/kg 2 days + melphalan 50-70mg/m2 | Drug: Flu-Bu-Mel<br>* 5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival (DFS) | From transplantation to documentation of death or relapse or progression | 1 year after transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | From transplantation to documentation of death due to any causes | 1 year after transplantation | 
| Relapse rate | From transplantation to documentation of relapse or progression | 1 year after transplantation | 
| non-relapse mortality (NRM) | From transplantation to documentation of death not due to disease relapse or progression | 1 year after transplantation | 
| acute graft versus host disease (aGVHD) | Incidence of documented grade II-IV acute GVHD | day 180 after transplantation | 
| chronic graft versus host disease (cGVHD) | Incidence of documented moderate to severe chronic GVHD | 1 year after transplantation | 
| relapse free survival (GRFS) | From transplantation to documentation of death, III-IV aGVHD, moderate to severe chronic GVHD and relapse | 1 year after transplantation |