SAA
Conditions
Interventions
Conditioning regimen Fludarabine 30mg/m2/day iv day-6,-5,-4,-3 Cyclophosphamide 25mg/kg/day iv day-6,-5,-4,-3 ATG(thymoglobulin) 1.25mg/kg iv day-4,-3 In case of HSCT from unrelated donor
Sponsors
Kanto Study Group for Cell Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Patients with severe acquired aplastic anemia 2. Patients who had received any kind of prior treatment other than HSCT will be included. 3. Patients who are 20 to 65 years old 4. Patients who have HLA matched related donor, single antigen mismatched related donor, HLA matched unrelated donor, and single DRB1 allele mismatched unrelated donor. 5. Patients in performance status of 0 or 1. 6. Patients whose major organ functions are preserved. 7. Patients from whom informed consent are obtained
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Patients with poorly controlled DM 2. Patients with poorly controlled hypertension 3. Patients with poorly controlled active infection 4. Patients with chromosome 7 abnormality 5. Patients with coexistence of malignancy 6. Patients who are pregnant or nursing 7. Patients with serious mental disorder 8. Patients with HBs antigen or HBe antigen positive 9. Patients with HIV antibody positive 10. Patients who are allergic to drugs used in conditioning regimen 11. Patients who had undergone allogeneic HSCT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| engraftment rate, rate of grade II-IV acute GVHD, rate of chronic GVHD, rate of mixed chimerism, rate of CMV disease, rate of PTLD | — |
Countries
Japan
Contacts
Public ContactShinichi Kako
Kanto Study Group for Cell Therapy Trial Office
Outcome results
None listed