Clinical trial
The Efficiency and Safety of N-acetylcysteine for Prevention of Thrombotic Events After Allogenic Hematopoietic Stem Cell Transplantation
Name
SOOCHOW-HY-2023-05-30
Description
We aim to assess the the efficiency and safety of N-acetylcysteine for prevention of thrombotic events after allogenic hematopoietic stem cell transplantation.
Trial arms
Trial start
2023-08-01
Estimated PCD
2025-08-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
N-acetyl-cysteine
8g/d (\>=45kg); 200mg/kg.d (\<45kg), intravenously for at least 4 hours, day -9 to day +45
Arms:
Arm A
Other names:
NAC
Busulfan
3.2mg/kg, day-7 to day -5, intravenously
Arms:
Arm A, Arm B
Other names:
BU
Cytarabine
2g/m2, day -8, intravenously
Arms:
Arm A, Arm B
Other names:
Ara-C
Cyclophosphamide
1.8g/m2, day -4 to day -3, intravenously
Arms:
Arm A, Arm B
Other names:
CTX
Size
260
Primary endpoint
The incidence of thrombotic disorders
1 year
Overall survival
1 year
Eligibility criteria
Inclusion Criteria:
1. Aged 16-70 years old
2. Diagnosed as myeloid malignancies, and about to undergo allo-HSCT;
3. ECOG: 0-2;
4. Expected survival longer than 1 month
Exclusion Criteria:
1. Allergic to any components of NAC;
2. Severe dysfunction of heart, liver, lung and kidney;
3. Relapse before HSCT;
4. A history of bronchial asthma, bronchospasm or moderate / severe gastrohelcosis.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 260, 'type': 'ESTIMATED'}}
Updated at
2023-06-18
1 organization
3 products
1 drug
1 indication
Product
N-acetyl-cysteineIndication
Thrombotic DisorderProduct
BusulfanProduct
CytarabineDrug
cyclophosphamide