AML,ALL,MDS,ML
Conditions
Interventions
1. Conditioning regimen Following regimen is recommended Flu 180mg/m2 + Bu 6.4-13.2mg/kg + TBI 4Gy or Mel 80mg/m2 2. GVHD prophylaxis Tacrolimus + MTX (day1,3,6: 5mg/m2)
Sponsors
North Japan Hematology Study Group (NJHSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who have hematologic malignancies as defined at least one of the following: a) Acute Leukemia: CR or PR b) Myelodysplastic syndrome: more than intermediate as defined by IPSS-R or more than high as defined by WPSS c) Lymphoma: CR or chemosensitive PR 2.Age: 15-70 years old. 3.Patients who have HLA more than 4/6 matched cord blood which have more than 2.0x107/kg of NCC disclosed by Japan Cord Blood Bank Network. 4.Performance status: 0-2 5.Patients with adequate physical function (Cardiac, Hepatic, Renal, Pulmonary). 6.Patients who give written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are positive for 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 has a prior history of allogeneic transplantation. 6.Patients who experienced serious hypersensitivity or anaphylaxis to MTX and who have large amount of pleural effusion or ascites. 7.Patients who are not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of grade III-IV acute GVHD at 100 days | — |
Countries
Japan
Contacts
Public ContactSouichi Shiratori
North Japan Hematology Study Group (NJHSG) Comittee of NJHSG
Outcome results
None listed