acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, malignant lymphoma
Conditions
Interventions
GVHD prophylaxis cyclophosphamide 40mg/kg for 2 days tacrolimus 0.02mg/kg/day Mycophenolate Mofetil 750mgx3/day
Sponsors
Division of Hematology & Oncology, Department of Medicine, Kurume University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation following reduced-intensity conditioning. 2. Age: 15-70 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. Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary). 6. Patients who have no HLA-matched or 7/8 matched, related donor. 7. Patients who have no HLA-matched or 7/8 matched, related donor. 8. Patients who give written informed consent to participate in the study. 9. 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 |
|---|---|
| Trasplant-related mortality at day 100 | — |
Countries
Japan
Contacts
Public ContactKoji Nagafuji
Kurume University School of Medicine Division of Hematology & Oncology, Department of Medicine
Outcome results
None listed