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Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.
Fludarabine and busulfan was considered as myeloablative but reduced toxicity regimen and became as the mainstay of conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The disease relapse remained as major cause of treatment failure. In general, the cumulated incidence of relapse (CIR) is about 15~20% dependent on the risk of patients undergoing allogeneic stem cell transplantation (allo-HSCT). Conditioning regimen with dual alkylating agents such as fludarabine, busulfan and thiotepa (TBF) showed decreased risk of relapse in myeloid malignancies. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan could achieve a low incidence of relapse (2 year CIR <10%). In this multiple-center randomize study, the aim is to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu vs. Flu-Bu-Mel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flu-Bu2-Mel140 | Experimental | Patients receive fludarabine, busulfan and melphalan as conditioning regimen |
|
| Flu-Bu4 | Active Comparator | Patients receive fludarabine and busulfan as conditioning regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine, busulfan and melphalan | Drug | FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease-free survival | event defined as relapse and death of any causes | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | event defined as death of any causes | 2 year |
| incidence of relapse | event defined as disease relapse (bone marrow or extra medullary) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chun Wang | Contact | 13386259777 | wangchunsh@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun Wang | Go Broad Health Center, Zhaxin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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study group with fludarabine, busulfan and melphalan regimen versus control group with fludarabine and busulfan
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| Fludarabine and Busulfan | Drug | FLudarabine 150mg/m2 + Busulfan 12.8mg.kg |
|
| 2 year |
| non relapse mortality | event defined as death without disease relapse | day 100 |
| non relapse mortality | event defined as death without disease relapse | 2 year |
| Zhongshan Hospital, Xianmen University | Recruiting | Xiamen | Fujian | 361004 | China |
|
| 923th Hospital PLA | Recruiting | Nanning | Guangxi | 530021 | China |
|
| First Affiliated Hospital of Nanjin Medical Unviersity | Recruiting | Nanjin | Jiangsu | 210029 | China |
|
| First Affiliatied Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
|
| Shanghai No10 Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| 920th Hospital PLA | Recruiting | Kunming | 650000 | China |
|
| Shanghai No 6 Hospital | Recruiting | Shanghai | China |
|
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D002066 | Busulfan |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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