Chronic myeloid leukemia, Acute myeloid leukemia, Acute lymphoid leukemia, Myelodysplastic syndrome, Malignant lymphoma
Conditions
Interventions
HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning
Sponsors
Health and Labour Sciences Research Grants, Research on Human Genome, Tissue Engineering, Ministry of Health, Labour and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) CML(2nd or later CP, AP, BC or relapse in non-CP state after allogeneic stem cell transplantation), AML(2nd or later CR, primary refractory or non-CR), ALL(2nd or later CR, primary refractory, non-CR or 1st CR in patients with Ph+ALL who could not achieve molecular remission), MDS/CMML(Int-II or high of the International Prognostic Scoring System, or relapse), Maglignant lymphoma (chemorefractory aggressive lymphoma) 2) Patients aged between 35 and 55 years. Patients aged between 18 and 35 years who are not eligible for myeloablative conditioning. 3) Written informed consent. 4) Unavailability of HLA-matched or -one antigen mismatched-related donor. Unavailability of HLA-matched or one allele mismatched-unrelated donor or needs urgent transplantation. 5) Availability of HLA-haploidentical family donor. 6) Performance status 0 or 1 7) Sufficient organ function
Exclusion criteria
Exclusion criteria: 1) Allergy for the agents used in conditioning or GVHD prophylaxis 2) Positivity for HBs antigen and/or HIV antibody 3) Active lesions in CNS 4) Active infections 5) Patients who are considered as inappropriate with other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutrophil engraftment within 35 days after transplantation (Phase I) Overall survival at day 100 after transplantion (Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of acute GVHD Incidence and severity of chonic GVHD Overall survival at 1 year after transplantation Diase free survival at 1 year after transplantation Treatment related mortality at 1 year after transplantation Incidence and severity of infectious disease after transplantation Immune reconstitution after transplantation | — |
Countries
Japan
Contacts
Public ContactSatoshi Yoshihara
Hyogo College of Medicine Division of Hematology, Department of Internal Medicine
Outcome results
None listed