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 range
1 Year – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.