Status:
UNKNOWN
Conditioning Regimen Containing Low Dose ATG for The Treatment of Acquired SAA Receiving sUCBT
Lead Sponsor:
Anhui Provincial Hospital
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
1-50 years
Brief Summary
To evaluate the safety and efficacy of Single Umbilical Cord blood transplantation (sUCBT) containing low dose ATG based conditioning regimen in the treatment of acquired Severe Aplastic Anemia (SAA).
Detailed Description
Hematopoietic stem cell transplantation (HSCT) from HLA-compatible sibling donors is the standard preferred therapy for Severe Aplastic Anemia (SAA). At present, HLA-compatible donors in China fail to...
Eligibility Criteria
Inclusion
- Patients diagnosed with severe aplastic anemia who do not respond to initial diagnosis or 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 HLA high-resolution matching、TNC (before cord blood freezing)≥3.0×107/kg、CD34+(before cord blood freezing)≥1.5×107/kg、tubule recovery rate≥80%;
- patients and their family members or guardians agreed to the study and signed informed consent;
- 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 use effective contraception during treatment and for one year thereafter.
Exclusion
- patients with inherited bone marrow failure syndromes;
- Positive for HLA-A, B, Cw, DRB1, DQB1, DPB1 site-specific HLA antibodies for donor cord blood with solid-phase fluorescence assay;
- patients who have previously received allogeneic hematopoietic stem cell transplantation 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 transplant treatment;
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06039436
Start Date
October 1 2023
End Date
May 31 2025
Last Update
October 24 2023
Active Locations (1)
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1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230036