Conditioning Regimen Containing Low Dose ATG for The Treatment of Acquired SAA Receiving sUCBT (NCT06039436) | Clinical Trial Compass
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Conditioning Regimen Containing Low Dose ATG for The Treatment of Acquired SAA Receiving sUCBT
China72 participantsStarted 2023-10
Plain-language 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).
Who can participate
Age range1 Year – 50 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 …