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NCT07586735
A Novel Conditioning Regimen for Haplo-HSCT in Older Patients With SAA
Conditions: Severe Aplastic Anemia, Aplastic Anaemia, Hematopoietic Cell Transplant
Sex: All
Ages: 40 Years – 60 Years
Healthy volunteers: No
Enrollment: 64
Sponsor: Peking University People's Hospital
Location: Peking Universtiy Peoples' Hospital Beijing Beijing Municipality
Summary
The goal of this prospective, multicenter, single arm observational study is to evaluate the efficacy and safety of the BFCA regimen in ≥ 40 years old SAA patients undergoing haplo-HSCT.
Eligibility Criteria
Inclusion Criteria:
* Severe aplastic anemia;
* Aged 40-60 years old;
* Weight 45Kg-100Kg;
* Eastern Cooperative Oncology Group (ECOG) score ≤3;
* No major organ injury (ECG ejection fraction \>45%; bilirubin \< 2 times the upper limit of normal value; AST and ALT \< 3 times the upper limit of normal value; serum creatinine \< 2 times the upper limit of normal value);
* No severe infection;
* Subjects voluntarily participated in this clinical trial and signed the informed consent.
Exclusion Criteria:
* With other hematologic diseases;
* Expected survival of less than 1 month;
* Previous autologous or allogeneic hematopoietic stem cell transplantation;
* Pregnant patients;
* Patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events;
* Other conditions that the investigator determines to be inappropriate for enrollment.
* Current or recent (\2 x ULN, or total bilirubin ≥1.5 x ULN
2. hemoglobin \
Source: ClinicalTrials.gov (NCT07586735). StuddyBuddy aggregates publicly available trial information.
