AML,MDS
Conditions
Interventions
Conditioning regimen: HLA matched related bone marrow (BM) or peripheral blood stem cell (PBSC) donor Flu 180mg/m2 + ivBu 12.8mg/kg HLA mismatched related BM or PBSC donor and unrelated BM donor F
s decision.) CB donor tacrolimus + oral mycophenolate mofetil (MMF)(30mg/kg/day in two divided doses, from day 0 to 30, and subsequently tapered and discontinued within 2 weeks, privided that ther
Sponsors
Japan Study Group for Cell Therapy and Transplantation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed as AML or MDS who meet the following conditions, (a)Patients with AML(except M3)who are in advanced stage beyond first complete remission, are in high risk disease category according to SWOG/ECOG criteria, received more than one course of chemotherapy to achieve complete remission, AML/MLD in first remission, or AML with prior history of myelodysplastic syndrome (B)Patients with MDS who are in poor prognosis group with high or very high score according to WHO classification-based prognostic scoring system, or required platelet transfusions of at least 10 units/week or red cell transfusions of at least 2 units/month. 2.Age:55-70 3.Those who have available donors(HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM, and HLA matched or less than 3 antigen-mismatched CB with more than 2 X 10^7/kg nucleated cells. 4.ECOG PS:0-2 5.Those who have no severe organ dysfunction (T. Bil<2.0mg/ml, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%) 6.Those who give written informed consent following sufficient explanation. 7.Those who are evaluated to be able to survive more than 3 months.
Exclusion criteria
Exclusion criteria: 1.Those who are positive for anti-HIV antibody 2.Those who have history of gemtuzumab ozogamicin (MylotargTM) use within 4 months 3.Those who have coinciding active malignancies 4.Those who have uncontrolled psychiatric disorder 5.Those who have active infection 6.Those who have prior hematopoietic stem cell transplantation 7.Those who have history of chemotherapy within 30 days before transplant (except hydroxycarbamide or cytarabine therapy for blast control) 8.Those who have hypersensitivity to drugs included in this protocol therapy 9.Those who are considered as inappropriate to register by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine overall survival with neutrophil engraftment at 60 days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Acomplishment rate of conditioning regimen 2.Incidence of grade 3 or higher adverse events up to 30 days after transplantation 3.Probability of achieving complete donor chimerism in 100 days after transplantation 4.Incidence of non-relapse mortality in 100 days after transplantation 5.Incidence of infections in 1 year after transplantation 6.Probabilities of disease-free survivals at 1 and 2 years after transplantation 7.Cumulative incidence of relapse at 1 and 2 years after transplantation 8.Probabilities of overall survival at 1 and 2 years after transplantation 9.Incidence and severity of acute and chronic GVHD in 1 and 2 years after transplantation 10.Sub-group analysis of above mentioned secondary outcomes according to stem cell sources | — |
Countries
Japan
Outcome results
None listed