Acute leukemia, Chronic myelogenous leukemia, Myelodysplastic syndrome
Conditions
Interventions
Conditioning regimen for cord blood transplant was twelve gray (Gy) total body irradiation (TBI), Cyclophosphamide (CPA) and high dose Ara-C with G-CSF for myeloid hematological malignant diseases, an
15 mg/m2 Day 1, 10 mg/m2 Days 3, 6) are used for GVHD prophylaxis. Eligible single cord blood unit is infused without processing on the day of transplant (Day 0) after rapid thawing in 37 degree Celsi
Sponsors
Research Grant on Tissue Engineering from the Japanese Ministry of Health, Labor & Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Patients with diseases described as follows: 1. de novo AML except CR1 2. ALL in remission except CR1 3.High-risk acute leukemia in CR1 where high-risk is defined as evidence of t(9;22) or failed to achieve CR after several courses of induction chemo therapy 4. CML in second CP or more advanced 5. MDS in RAEB-1, RAEB-2 or RA with high-risk chromosomal abnormalities who require frequent transfusions B. Patient who has no HLA-matched or one antigen-mismatched relatives C. Patient who has adequate CB unit in CB banks in Japan D. Age between 20 and 54 years E. Performance states (ECOG)=0 or 1 F. No major organ dysfunctions described as follows: 1. SaO2; less than 95% in room air 2. Serum creatinine and total bilirubin; greater than 1.5 x normal value 3. AST and ALT; greater than 2 x normal value 4. Left ventricular ejection fraction; lower than 55% G. Negative for anti-HLA antibody H. Written informed consent to participate the trial
Exclusion criteria
Exclusion criteria: 1.Active disease in central nerve system. 2.Uncontrollable diabetes 3.Uncontrollable hypertension 4.Active infection 5.Positive for TPHA or HBs antigen 6.Positive for HIV antibody 7.Malignancies addition to primary hematological malignant disease 8.Pregnant or during breast feeding 9.History of stem cell transplantation including autologous transplantation 10.Uncontrollable psycho-neurological symptoms 11.Physician's decision that it is not appropriate to register the patient to this study for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival at one year after cord blood transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Incidence and time of engraftment 2.Incidence and severity of acute GVHD 3.Incidence and severity of chronic GVHD 4.Disease-free survival and overall survival 5.Causes and incidence of sever toxicity 6.Incidence of relapse 7.Incidence of treatment-related toxicity (TRM) 8.Analysis of incidences of TRM between institutions | — |
Countries
Japan
Contacts
Public ContactSatoshi Takahashi
The University of Tokyo Institute of Medical Science attachment hospital Internal Medicine
Outcome results
None listed