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Azacitidine and NAC for Prolonged Isolated Thrombocytopenia Post-HSCT
NCT05126004Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Dec 2021
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- First Affiliated Hospital of Soochow University
- Modality
- Small Molecules
- Conditions
- isolated thrombocytopenia
01
Overview
Phase 2, randomised, open-label trial of azacitidine and acetylcysteine in isolated thrombocytopenia (2 arms), sponsored by First Affiliated Hospital of Soochow University. Primary endpoint: Time to platelet reconstruction at 100 days. Planned start Dec 2021; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Control group
Supportive care
AZA+NAC group
Azacitidine + N-Acetyl-L-cysteine
03
Who it enrols
Patients with prolonged isolated thrombocytopenia (platelet count <= 30 * 10^9/L) at day 60 post-HSCT or later, with full donor chimerism and recovered neutrophil/hemoglobin. Excludes malignancy relapse, active infections, grade 3-4 acute GVHD or severe chronic GVHD, severe organ damage, and thrombosis requiring treatment.
04
Endpoints
Primary
Time to platelet reconstruction
Secondary
Overall Survival
Overall Response Rate
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