CML(chronic myelogenous leukemia) AML(acute myeloid leukemia) MDS(myelodysplastic syndrome)
Conditions
Interventions
Conditioning regimen Intravenous busulfan 3.2mg/kg/day x 4days + cyclophosphamide 60mg/kg/day x 2days
Sponsors
Kanto Study Group for Cell Therapy Nagoya Blood and Marrow Transplantation (NBMT) Group
Center for Supporting Hematology-Oncology Trial(C-SHOT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients between the age of 16 and 55 at informed consent (2) Patients diagnosed as CML, AML, or MDS who are eligible for allogeneic hematopoietic stem cell transplantation. No limitation of disease status at transplantation. Patients who need chemotherapy for disease control except imatinib, dasatinib and nilotinib for CML are excluded. (3) Patients who have the fixed schedule about the harvest of bone marrow or peripheral blood stem cells from related or unrelated donors who meet the following conditions: 1) HLA-A, B, DRB1 are genetically identical 2)HLA-A and B are genetically identical and 1 locus of HLA-DRB1 is genetically mismatched (4) Patients whose performance status are 0 or 1 by ECOG criteria (5) Patients who meet all of the following conditions: 1) SPO2>=94% by room air 2) sCr=<2.0mg/dL 3) T-bil=<1.5mg/dL 4) AST, ALT and r-GTP=<3 x upper limit of normal 5) Absence of abnormal findings of ECG which require therapeutic interventions 6) Ejection fraction of left ventricle>=50% by UCG (6) Patients who give written informed consent following sufficient explanation. Patients who are under 20 years old are required to give informed consent from both persons with parental authority and patients themselves
Exclusion criteria
Exclusion criteria: (1) Patients with uncontrolled diabetes mellitus in spite of regular use of insulin (2) Patients with uncontrolled hypertension in spite of use of antihypertensive drugs (3) Patients who have active infection (4) Patients who are positive for TPHA, HBV surface antigen, or anti-HCV antibody. (5) Patients who are positive for anti-HTLV-I or anti-HIV antibody (6) Patients who are not evaluated to be able to survive more than 100 days after transplantation (7) Patients who have coinciding active malignancies (8) Patients who are pregnant or in the lactation period (9) Patients who have psychiatric disorder (10) Patients who have prior hematopoietic stem cell transplantation (11) Patients who are considered as inappropriate to register by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Probability of event-free survival at 1 year after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Incidence of Bearman's grade 2 or higher adverse events within 28 days after transplantation (2) Cumulative incidence of engraftment at 100 days after transplantation (3) Cumulative incidence of non-relapse mortality at 100 days after transplantation (4) Cumulative incidence of SOS (sinusoidal obstruction syndrome) at 100 days after transplantation (5) Cumulative incidence of Grade II-IV acute GVHD at 1 year after transplantation (6) Cumulative incidence of chronic GVHD at 1 year after transplantation (7) Probability of overall survival and cumulative incidence of relapse at 1 year after transplantation | — |
Countries
Japan
Contacts
Public ContactTakuya Yamashita, Sawa Masashi
KSGCT, NBMTG Study Coordinators
Outcome results
None listed