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NAC for Hematopoietic Recovery in AML
NCT06024031Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Sep 2023
- Primary completion
- Sep 2024
- Countries
- 1
- Sponsor
- Peking University People's Hospital
- Modality
- Small Molecules
- Drugs
- acetylcysteine
- Conditions
- acute myeloid leukemia (AML)
01
Overview
Phase 2, open-label, single-arm trial of acetylcysteine in acute myeloid leukemia (AML), sponsored by Peking University People's Hospital. Primary endpoint: Time to hematopoietic recovery post chemotherapy at 2 months. Started Sep 2023; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
NAC group
Patients receive N-acetyl-L-cysteine (400mg tid) orally from day 1 to day 28 after induction chemotherapy.
03
Who it enrols
Newly diagnosed AML patients (excluding M3) aged 18-60 with low or intermediate risk, adequate organ function, and no uncontrolled infections or history of bronchial asthma.
04
Endpoints
Primary
Time to hematopoietic recovery post chemotherapy
Secondary
complete remission rate
relapse-free survival
overall survival
Adverse reactions
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