Last updated: October 22, 2023
Sponsor: Anhui Provincial Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aplastic Anemia
Treatment
Anti-Thymocyte Globulin (Rabbit)
Clinical Study ID
NCT06039436
CBSAA001
Ages 1-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients diagnosed with severe aplastic anemia who do not respond to initial diagnosisor immunosuppressive therapy;
- Patients meet diagnostic criteria for severe aplastic anemia (Camitta criteria);
- Age from 1 to 50 years old, male or female;
- Patients without HLA-matched sibling or unrelated donors avaliable;
- Patients who have undergone unrelated cord blood transplantation need to have HLAhigh-resolution matching、TNC (before cord blood freezing)≥3.0×107/kg、CD34+(before cordblood freezing)≥1.5×107/kg、tubule recovery rate≥80%;
- patients and their family members or guardians agreed to the study and signed informedconsent;
- No severe organ failure;
- ECOG score≤2 and HCT-CI≤2;
- serum ferritin (SF)<1000ug/L;
- women of reproductive agemust have a negative pregnancy test and agree to useeffective contraception during treatment and for one year thereafter.
Exclusion
Exclusion Criteria:
- patients with inherited bone marrow failure syndromes;
- Positive for HLA-A, B, Cw, DRB1, DQB1, DPB1 site-specific HLA antibodies for donorcord blood with solid-phase fluorescence assay;
- patients who have previously received allogeneic hematopoietic stem celltransplantation or solid organ transplantation;
- Uncontrolled bacterial, viral, or fungal infections;
- HIV infection or active viral hepatitis B or C infection;
- Pregnant or breastfeeding women;
- patients with a history of primary malignancy within 3 years prior to transplanttreatment;
- patients receiving ATG treatment within 2 weeks before transplantation;
- patients with drug dependent or uncontrolled mental illness or cognitive impairment;
- Participants in other similar clinical studies within 3 months;
- Patients allergic to ATG;
- patients considered unsuitable for inclusion by the researchers.
Study Design
Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Anti-Thymocyte Globulin (Rabbit)
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
May 31, 2025
Study Description
Connect with a study center
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui 230036
ChinaActive - Recruiting
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