Status:
TERMINATED
Prolonged Isolated Thrombocytopenia After Allo-SCT : N-acetyl-L-cysteine (NAC) Versus Supportive Therapy
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Nanfang Hospital, Southern Medical University
Conditions:
Thrombocytopenia
Stem Cell Transplant Complications
Eligibility:
All Genders
14+ years
Phase:
PHASE2
PHASE3
Brief Summary
Isolated prolonged thrombocytopenia (PT) is a common complication after allogeneic stem cell transplantation with significant poor prognosis. No standard treatment is available. The current study assi...
Detailed Description
1. patients diagnosed with PT at day 60 post transplant will be randomized assigned to intervention arm (NAC) or controlled arm (supportive therapy: prophylactic platelet transfusion was given when pl...
Eligibility Criteria
Inclusion
- age\>= 14 years
- diagnosed as PT (defined as platelet count in peripheral blood never achieve 20000/miro-liter for 7 consecutive days without transfusion at day 60 post transplantation)
- serum creatine level \< ULN (upper limit of normal), serum ALT/AST /TBil\<=2 ULN
- without active CMV/EBV/ADV reactivation, active GVHD, without relapse or minimal residual disease at enrollment
Exclusion
- history of asthma
- allergy to NAC
- refuse to participate
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03391856
Start Date
March 1 2018
End Date
December 30 2018
Last Update
September 25 2020
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044