Acute myeloid leukemia AML with multilineage dysplasia Myelodysplastic syndrome Acute lymphoblastic leukemia Chronic myeloid leukemia Adult T cell leukemia/lymphoma Malignant lymphoma
Conditions
Interventions
Myeloablative conditioning regimen consists of Ara-C, cyclophosphamide and TBI12Gy. Nonmyeloablative conditioning regimen consists of fludarabine 180mg/m2, intravenous busulfan 8mg/kg,and TBI 4Gy.
Sponsors
Hematology, Osaka City University, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hematologic malignancies who have an indication for allogeneic stem cell transplantation 2. Patients lacking HLA-matched (by serological typing) related, HLA single-antigen mismatched related donor or HLA-identical (by serological typing) unrelated donor 3. ECOG PS 0-1 4. Informed consent Eligible diseases and status I. AML: regardless of disease status II. AML with multilineage dysplasia (regardless of disease status) III.MDS i)RAEB1,2 ii)RA with transfusion dependence or RA with poor risk cytogenetics IV. ALL (including Ph ALL): regardless of disease status V. CML: Chronic phase resistant to tyrosine kinase inhibitors, Acceleration phase or Blast crisis VI:ATLL acute type or lymphoma type: regardless of disease status VII: Malignant lymphoma (regardless of disease status Eligibility for the myeloablative conditioning regimen (patient must fulfill all the following criteria 1-3) 1. Age: 16=<, =<55 years old at enrollment 2. Normal function of major organ: (must fulfill the following criteria a-d) a. %VC>40%, FEV1.0%>50% and SaO2>70mmHg (SpO2>94%) on room air b. EF>50% c. Serum creatinine level <1.5mg/dl d. T-Bil<1.5mg/dl and ALT within normal limits 3. No history of high-dose chemotherapy (or radiation) followed by stem cell transplantation: regardless of the time of transplantation and types of stem cell source Eligibility for the nonmyeloablative conditioning regimen (patient must fulfill any of the following criteria) 1. Age: =>56 years old at enrollment 2. Major organ dysfunction confirmed within the last 28 days before enrollment a.30%=<%VC=<40%, 40%=<FEV1.0%=<50%, 50mmHg=<SpO2=<70mmHg (SpO2 90-94%) on room air b. EF: =>30%, =<50% c. Serum creatinine level: 1.5-2.0mg/dl d. T-Bil: 1.5-2.0mg/dl or ALT: more than normal limit and within 3 times of UNL 3. A history of high-dose chemotherapy (radiation) followed by stem cell transplantation: regardless of the time of transplantation and types of stem cell source
Exclusion criteria
Exclusion criteria: 1. Dysfunction of major organ which meets any of the following criteria. a. T-Bil > 2.0mg/dl b. Cre > 2.0mg/dl c. EF >30% d. %VC <30%, FEV1.0% <40% or SaO2 < 50mmHg on room air (SpO2 <90%) e. AST: beyond 3 times of UNL 2. Active infection 3. Poorly controlled diabetes mellitus despite the use of insulin 4. Poorly controlled hypertention 5. Severe complications including heart failure, coronary failure, myocardial infarction within the last 3 months, liver cirrhosis and interstitial pneumonia 6. Pregnant, nursing of possible fertile woman 7. Severe mental disorder who is unlikely to be able to participate in the study 8. A history of hypersensitivity or allergy to any drugs in conditioning regimen of this transplantation 9. HIV antibody positivity 10. No indication for this study judged by physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Engraftment rate | — |
Countries
Japan
Contacts
Public ContactMika Nakamae
Osaka City University, Graduate School of Medicine Clinical research center for hematological malignancies
Outcome results
None listed