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Recruiting Observational

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

NCT07586735 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2026-06
Last updated
2026-07-06

Condition(s) studied

Severe Aplastic AnemiaAplastic AnaemiaHematopoietic Cell Transplant

Investigational drug(s) / intervention(s)

BFCA conditiong regimen

BFCA conditiong regimen: busulfan 0.8 mg/kg/6h (days -8 to -7), fludarabine 30mg/m2/day (days -6 to -2), cyclophosphamide 25 mg/kg/day (days -5 to -2) and antithymocyte globulin(ATG) 2.5 mg/kg/day (days -5 to -2).

Study 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

Sex
ALL
Min age
40 Years
Max age
60 Years
Healthy volunteers
No
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 (\<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 * Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * 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 * Clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled * Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure * 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 * Any of the following specific abnormalities on screening laboratory tests: 1. ALT or AST \>2 x ULN, or total bilirubin ≥1.5 x ULN 2. 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) 3. eGFR \<50 mL/min/1.73 m2

Primary outcome measure(s)

  • Faliure free survival (FFS) — From enrollment to 2 years post-HSCT
    survival with a response to therapy after HSCT. Death, graft faliue and relapse were considered as treatment failure.

Trial sites (1)

FacilityCityRegionStatus
Peking Universtiy Peoples' Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586735 on ClinicalTrials.gov ↗ ← All trials in China