Refractory hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome, malignant lymphoma, multiple myeloma, severe aplastic anemia)
Conditions
Interventions
HLA 2-3 antigen mismatched stem cell transplantation from related donor
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent. 2) Unavailability of HLA (A, B, DR)-matched or -one antigen mismatched-related donor. 3) Unavailability of HLA (A, B, DR)-matched or one allele of HLA-DRB1 mismatched-unrelated donor or needs urgent transplantation. 4) Availability of HLA 2-3 antigen mismatched related donor. 5) In case of hematologic malignancy in an advanced stage, patients could choose an HLA 2-3 antigen-mismatched donor, even if they have an HLA-matched or -1 antigen-mismatched donor. 6) Sufficient organ function 6-1) Ejection Fraction >= 50% 6-2) serum total billirubin is needed to be less than 2.5 times the normal upper limit 6-3) serum creatinine level <= 1.5* upper limit of institution
Exclusion criteria
Exclusion criteria: 1) Allergy for the agents used in conditioning or GVHD prophylaxis 2) Patients who are considered as inappropriate with other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of donor cell engraftment (>90% of donor origin) and incidence of severe GVHD (Phase I) Disease free survival at 1 year after transplantation (Phase II) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of chronic GVHD Treatment related mortality within 1 year after transplantation Incidence of infections (bacteria, fungus, virus, etc) Immune reconstitution after transplantation GVL effect Late onset transplantation related complications | — |
Countries
Japan
Contacts
Public ContactKazuhiro Ikegame
Hyogo College of Medicine Division of Hematology, Department of Internal Medicine
Outcome results
None listed