Acute Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
conditioning regimen, melphalan, busulfan, fludarabine
Brief summary
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.
Detailed description
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.
Interventions
FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2
FLudarabine 150mg/m2 + Busulfan 12.8mg.kg
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
study group with fludarabine, busulfan and melphalan regimen versus control group with fludarabine and busulfan
Eligibility
Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission * myelodysplasia syndrome with bone marrow blast \>5% and remaining less than 20% at transplantation * patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors * inform consent provided
Exclusion criteria
* AML patients with active CNS or extramedullary diseases * patients with active viral, bacterial or fungal infection * patients with hepatitis B virus \>1X103 copy/ml * patients with abnormal liver function, renal function, respiratory or cardiac dysfunction * patients with uncontrolled mental disorders * patients with HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 2 year | event defined as relapse and death of any causes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 2 year | event defined as death of any causes |
| incidence of relapse | 2 year | event defined as disease relapse (bone marrow or extra medullary) |
| non relapse mortality | day 100 | event defined as death without disease relapse |
Countries
China
Contacts
Primary Contactchun Wang
Outcome results
None listed