Acute myeloid leukemia(AML), Myelodysplastic syndrome(MDS), Acute lymphoblastic leukemia(ALL), Malignant lymphoma(ML), chronic myeloid leukemia(CML)
Conditions
Interventions
Conditioning regimen 1) HLA matched related BM or PBSC donor Fludarabine (Flu) 150mg/m2 + Cytarabine arabinoside (AraC) 8-16g/m2 + Cyclophosphamide (Cy) 50mg/kg 2) HLA mismatched related BM or PBSC
s decision.) 3) Cord blood Cyclosporine + short-term MTX(day 1: 10mg/m2, day 3, 6: 7mg/m2)
Sponsors
Gifu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed as hematological malignancies who meet the following conditions, a)AML 1.AML in advanced stage beyond CR1, received more than one course of chemotherapy to achieve CR, in high risk disease category according to SWOG/ECOG criteria, or in non-CR including relapse after auto or allo-SCT. 2.AML who have less than 30% bone marrow blasts at the registration. b)MDS in poor prognosis group with WPSS high or very high, relapse after remission (including transplantation), or required platelet or red cell transfusions) b)ALL 1.ALL in CR1 with a poor prognostic factor, in >=CR2, received more than one course of chemotherapy to achieve CR, in non-CR including relapse after auto or allo-SCT, or Ph+ALL in CR1 without achievement of MR. 2.ALL who have less than 30% bone marrow blasts at the registration. d) ML 1.One of the following type of the histological type (WHO classification) Precursor B- and T-cell neoplasms Mature B-cell neoplasms Mature T-cell and NK-cell neoplasms Hodgkin lymphoma 2.ML who did not achieve PR after first-line chemotherapy, first relapsed ML who did not achieve PR after first-line salvage therapy , second relapsed ML, or in non-CR including relapse after auto-PBSCT. e)CML 1.CML in CP with resistance to TKI or the T315I mutation, second or subsequent CP, AP, BP, or relapsed in non-CP including relapse after auto or allo-SCT. 2.CML who have less than 30 % bone marrow blasts at the registration. 2)Aged from 55 to 70 years old or aged from 20 to 55 years old with significant comorbidity. 3)Patients who have available donors (HLA-identical or 1 antigen-mismatched related BM/PBSC, HLA-matched or 1 DR antigen-mismatched unrelated BM, less than 2 antigen-mismatched CB with more than 2x10^7/kg) 4)ECOG performance status 0-2 5)Patients who have no severe organ dysfunction (T.Bil<2.0mg/dl, AST, ALT<=2.5xULN, Cr<2.0mg/dl, EF>50%, SpO2>95%) 6)Patients who give a written informed consent 7)Patients who are evaluated to be able to survive more than 3 months
Exclusion criteria
Exclusion criteria: 1) Patients with HIV 2) Patients who received gemtuzumab ozogamicin within 3 months 3) Patients with another active malignancy 4) Patients with severe mental disease 5) Patients with severe central nervous system (CNS) lesions (except for CNS lesions of the underlying disease) 6) Patients with active infection 7) Patients who have history of chemotherapy within 21 days before transplantation (except hydroxyurea, cytarabine, or etoposide therapy for blast control) 8) Patients who have hypersensitivity to drugs included in this protocol 9) Patients who are judged inappropriate for the entry into the study by the principle doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Donor cell engraftment rate and survival rate at 60 days after transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Completion rate of conditioning regimen and protocol 2) Incidence of grade 3 or higher adverse events within 60 days after transplantation 3) Achievement rate of complete donor chimaerism within 100 days after transplantation 4) Non-relapse mortality within 100 days after transplantation 5) Incidence of infection within 1 year after transplantation 6) Incidence and severity of chronic GVHD within 1 year and 2 years after transplantation 7) Relapse rate within 1 year and 2 years after transplantation 8) Disease free survival within 1 year and 2 years after transplantation 9) Overall survival within 1 year and 2 years after transplantation 10) Subgroup analysis of donor source 11) Subgroup analysis of underlying disease | — |
Countries
Japan
Contacts
Public ContactNobuhiro Kanemura
Gifu University Hospital First Department of Internal Medicine
Outcome results
None listed