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A Novel Conditioning Regimen for Haplo-HSCT in Older Patients With SAA

Key facts

Where
Beijing, ChinaSee the site

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 40 and 60 years old?

Source: NCT07586735, who can take part

Where in China

  • Peking Universtiy Peoples' HospitalBeijing, ChinaContact: Tingting Han, DoctorTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Peking University People's Hospital
Trial code
NCT07586735
Record updated
6 July 2026
Original description
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.Read full original descriptionShow less

A Novel Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplant in Patients Aged ≥ 40 Years Old With Severe Aplastic Anemia: a Multicenter, Single-arm, Observational Clinical Trial

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.

Inclusion: 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: Previous autologous or allogeneic hematopoietic stem cell transplantation; Current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection; A history of symptomatic herpes zoster infection within 12 weeks prior to screening; Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB; Exposure to a live vaccine within 12 weeks prior to enrollment or expected to receive a live vaccine during the study; A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data; With other hematologic diseases; 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; Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure; Any of the following specific abnormalities on screening laboratory tests:; ALT or AST >2 x ULN, or total bilirubin ≥1.5 x ULN; hemoglobin <9 g/dL, or total white blood cell (WBC) count <2,500/µL, or neutropenia (absolute neutrophil count <1,200/µL), or lymphopenia (lymphocyte count <750/µL); eGFR <50 mL/min/1.73 m2; Expected survival of less than 1 month; Pregnant patients; Clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled.

ClinicalTrials.gov NCT07586735