ALL,AML,MDS,CML,NHL,MM
Conditions
Interventions
The preparative regimen will consist of : Fludarabine 30mg/m2 IV Days -6, -5, -4, -3, -2 Cyclophosphamide 14.5mg/kg IV Days -6, -5 Busulfan 3.2mg/kg IV Days -3, -2 Total body irradiation (TBI) 2Gy
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. Patients who have prior allogeneic or autologous hematopoietic stem cell transplant are not excluded. 5. Performance status: 0-2 6. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary). 7. Patients who have no HLA-matched or 7/8 matched, related donor. 8. Patients who have no HLA-matched or 7/8 matched, related donor. 9. Patients who give written informed consent to participate in the study. 10. Patients who are expected to live for 3 months or more.
Exclusion criteria
Exclusion criteria: 1. Patients who are positive for HBs antigen, HCV antibody, or HIV antibody. 2. Patients with active other malignancies. 3. Patients with active infectious disease. 4. Women who are pregnant, of childbearing potential, or lactating. 5. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide, fludarabine, tacrolimus, mycophenolate mofetil. 6. Positive anti-donor HLA antibody. 7. Patients who need chemotherapy within 13 days before transplantation. 8. Patients who are not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant-related mortality at 100 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall survival, progression-free survival, relapse at 100 days. 2. Overall survival, progression-free survival, Relapse, Transplant-related mortality at 1 year. 3. Neutrophil and platelet recovery. 4. Graft failure. 5. Full donor chimerism. 6. Acute Graft-versus-Host Disease. 7. Chronic Graft-versus-Host Disease. 8. Infection 9. Grade 3-4 non-hematologic toxicity within 100 days. | — |
Countries
Japan
Contacts
Public ContactJSCT
JSCT Haplo13 DC
Outcome results
None listed