acquired severe aplastic anaemia
Conditions
Interventions
Cord blood:Flu+Cy+TBI
Haploidentical:Bu/Cy/ATG
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of SAA, either from initial diagnosis or follow-up assessments, defined as: Bone marrow cellularity 13.0 years of age at the time of enrollment: estimated creatinine clearance > 50 mL/minute (using the Cockcroft-Gault formula and actual body weight). For patients < 13.0 years of age at enrollment: Glomerular Filtration Rate (GFR) estimated by the updated Schwartz formula = 90 mL/min/1.73 m2. If the
Exclusion criteria
Exclusion criteria: 1. Inherited bone marrow failure syndromes; 2. Presence of anti-donor HLA antibodies (positive anti-donor HLA antibody is defined as a positive cross-match test of any titer by complement-dependent cytotoxicity or flow cytometric testing or the presence of anti-donor HLA antibody to the high expression loci HLA-A, B, C, DRB1, or DPB1 with mean fluorescence intensity (MFI) > 1000 by solid phase immunoassay); 3. Prior allogeneic stem cell transplant or prior solid organ transplant; 4. Uncontrolled bacterial, viral, or fungal infection at the time of enrollment. Uncontrolled is defined as currently taking medication and with progression or no clinical improvement on adequate medical treatment; 5. Seropositive for the human immunodeficiency virus (HIV) or active Hepatitis B or C determined by a detectable viral load of HBV or HCV; 6. Female patients who are pregnant (per institutional practice) or breast-feeding; 7. Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; 8. ATG within 2 weeks of enrollment; 9. Drug addicts; uncontrolled mental disorders subjects; cognitive dysfunction; 10. Participate in other similar clinical studies within 3 months; 11. Researchers consider that patients who are not suitable for inclusion (if patients are expected to be unable to adhere to treatment due to funding problems).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of neutrophil engraftment;incidence of platelet engraftment;incidences of acute graft-vs-host-disease (aGVHD);incidences of chronic graft-vs-host-disease (cGVHD);immune reconstitution;incidences of infection;1 year incidence of relapse;Health Related Quality of Life (HR-QoL);180 days transplantation related mortality;1 year GVHD-free, relapse-free survival (GRFS);1 year disease-free survival (DFS); | — |
Countries
China
Contacts
Public ContactZimin Sun
The First Affiliated Hospital of USTC, Division of Life Sciences and Medcine, University of Science and Technology of China
Outcome results
None listed