Conditioning Regimen Containing Low-Dose ATG for the Treatment of AA Receiving sUCBT
Key facts
- Where
- Hefei, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 50 years old?
Source: NCT07885982, who can take part
Where in China
- The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)Hefei, ChinaContact: Xiaoyu Zhu, Ph.DNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Anhui Provincial Hospital
- Trial code
- NCT07885982
- Record updated
- 21 October 2026
- Original description
To evaluate the safety and efficacy of Single Umbilical Cord blood transplantation (sUCBT) containing low dose ATG based conditioning regimen in the treatment of Aplastic Anemia (AA)Read full original descriptionShow less
Conditioning Regimen Containing Low-Dose Antithymocyte Globulin (ATG) for the Treatment of Aplastic Anemia Receiving Single-Unit Umbilical Cord Blood Transplantation: A Multicenter, Single-Arm Study
To evaluate the safety and efficacy of Single Umbilical Cord blood transplantation (sUCBT) containing low dose ATG based conditioning regimen in the treatment of Aplastic Anemia (AA)
Inclusion: Diagnosis of severe aplastic anemia (SAA) according to the Camitta criteria, transfusion-dependent non-severe aplastic anemia (TD-NSAA), or inherited bone marrow failure syndrome (IBMFS) with an indication for allogeneic hematopoietic stem cell transplantation (HSCT); Age 1 to 50 years, regardless of sex; No available HLA-matched sibling donor or 10/10 HLA-matched unrelated donor; Eligible for single-unit unrelated umbilical cord blood transplantation (UCBT) using a cord blood unit that meets the protocol-defined HLA matching and minimum cell dose requirements; Negative donor-specific anti-HLA antibodies (DSA) against the selected cord blood unit before transplantation; Adequate cardiac, hepatic, renal, and pulmonary function; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) score 0-2; Serum ferritin <1000 μg/L, or prior iron chelation therapy if serum ferritin exceeds this threshold; Female participants of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during treatment and for 12 months after transplantation; Ability to understand the study requirements and provision of written informed consent by the participant or the participant's legally authorized representative.
Exclusion: Previous allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation; Treatment with rabbit antithymocyte globulin (rATG) within 2 weeks before transplantation; Participation in another interventional clinical trial within 3 months before enrollment; Diagnosis of myelodysplastic syndrome (MDS), paroxysmal nocturnal hemoglobinuria (PNH), or other hematologic disorders causing pancytopenia; Active, uncontrolled bacterial, viral, or fungal infection despite appropriate antimicrobial therapy; Human immunodeficiency virus (HIV) infection or active hepatitis B or hepatitis C infection; History of malignancy within 3 years before transplantation, except adequately treated basal cell carcinoma or carcinoma in situ of the cervix; Known hypersensitivity to rabbit antithymocyte globulin (rATG); Active substance abuse, uncontrolled psychiatric illness, cognitive impairment, or any condition that may interfere with study participation or protocol compliance; Any medical, psychological, or social condition that, in the opinion of the investigator, would make the participant unsuitable for the study or interfere with study participation or follow-up; Pregnancy or breastfeeding.