AML,MDS
Conditions
Interventions
Sponsors
JSCT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation. 2. Age: 15-65 years old. 3. 2nd CR or subsequent CR, non CR. 1st CR as defined at least one of the following: a) Acute lymphoblastic leukemia Poor risk as defined by NCCN guidelines b) Acute Myelogenous Leukemia Greater than 1 cycle of induction therapy required to achieve remission High risk as defined by NCCN guidelines Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15) Preceding myelodysplastic syndrome c) Myelodysplastic syndrome high, very high as defined by WHO classification-based Prognostic Scoring System Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month. 4. Performance status: 0-2 5.Those who have available donors(HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM 6.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%) 7.Those who give written informed consent following sufficient explanation. 8.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival at 1 year after transplantation | — |
Countries
Japan
Outcome results
None listed