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| Name | Class |
|---|---|
| Shanghai Clinical Research Center | UNKNOWN |
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Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
Intensity of conditioning regimen plays a important role in allogeneic stem cell transplantation (allo-HSCT) for patents with AML and MDS. IN our previous prospective study, we demonstrated that condoning regimen of dual alkylating agents with melphalan-busulfan and fludarabine (MBF) achieved a very low relapse rate (~6%) in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In that study, adult patients received melphalan 140mg/m2 while patients >=60 or with high transplantation risk in terms of HCT-CI received reduced dose of melphalan (100mg/m2). Overall, it was shown that 100 or 140mg/m2 melphalan had similar incidence of relapse while the 100mg/m2 melphalan presented lower incidence of toxicities.In this prospective randomize study, we aim to compare the transplantation toxicities and outcomes in young adults (18~55) with AML/MDS receiving either 100 or 140 mg/m2 melphalan as conditioning regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBF100 | Experimental | Patients receive condoning regimen with melphalan (100mg/m2) with busulfan and fludarabine. |
|
| MBF140 | Active Comparator | Patients receive condoning regimen with melphalan (140mg/m2) with busulfan and fludarabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| melphalan | Drug | conditioning regimen with melphalan, busulfan and fludarabine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities | Toxicities with grade III or over | up to 100 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | Documentation of bone marrow blasts >5% or extra medullary disease | 2 years |
| Non-relapse mortality | Death without documentation of AML and MDS disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chun Wang | Contact | 86-13386259777 | Wangchunsh@mefmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| chun Wang | Go Broad Health Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rui Jin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
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Treatment
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| 100 days |
| Non-relapse mortality | Death without documentation of AML and MDS disease | 2 years |
| disease-free survival | event defined as documentation of AML and MDS relapse or death of any causes | 2 years |
| overall survival | event defined as death of any causes | 2 years |
| Zhaxin Hospital, Go Broad Health Care | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009930 |
| Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |