Status:
NOT_YET_RECRUITING
NAC for Hematopoietic Recovery in SAA
Lead Sponsor:
Peking University People's Hospital
Conditions:
Aplastic Anemia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
This is a prospective single-arm clinical study to evaluate the role of NAC among patients with severe aplastic anemia (SAA) can promote hematopoietic recovery after haploidentical transplantation.
Detailed Description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective treatment of severe aplastic anemia (SAA). However, poor hematopoietic reconstitution including poor graft function (PGF)...
Eligibility Criteria
Inclusion
- Diagnosed with SAA or vSAA
- Aged 18-50
- No severe organ injury
- No uncontrolled active infections
- Sign informed consent form, have the ability to comply with study and follow-up procedures
Exclusion
- Hypersensitivity to NAC or history of bronchial asthma
- Life expectancy less than 30 days post-transplantation
- Uncontrolled infections pre-transplantation
- Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- Respiratory failure ( PaO2 ≤60mmHg)
- Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal \[ULN\], alanine aminotransferase or aspartate aminotransferase ≥2 times the ULN)
- Renal dysfunction (creatinine ≥1.5 times the ULN or creatinine clearance rate \< 30 mL/min)
- ECOG performance status ≥3
- With any conditions not suitable for the trial (investigators' decision)
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06518044
Start Date
July 25 2024
End Date
July 1 2025
Last Update
July 24 2024
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