This prospective, single-center, randomized controlled clinical trial aims to evaluate whether N-acetyl-L-cysteine (NAC) can promote hematopoietic recovery after chemotherapy in patients with acute myeloid leukemia (AML), and to explore its effects on disease remission and bone marrow microenvironment.
Eligible participants are newly diagnosed low- or intermediate-risk AML patients aged 18-65 years, with no severe organ dysfunction or active infection. After completing induction chemotherapy with the HAA regimen, subjects will be randomly assigned in a 1:1 ratio to receive either NAC (400 mg orally three times daily for 28 days) plus standard care (intervention group) or standard care alone (control group). A total of 180 patients will be enrolled, with 90 patients in each group.
The primary endpoint is the time to platelet recovery, defined as the number of days from the first day of chemotherapy until the first day that platelet count reaches ≥20×10⁹/L and remains stable for 7 consecutive days without transfusion support. Secondary endpoints include time to neutrophil recovery, total dose of G-CSF administered, total volume of red blood cell and platelet transfusions, complete remission rate, relapse-free survival, overall survival, and adverse events.
The primary efficacy analysis will be performed in the intention-to-treat (ITT) population. Continuous variables will be compared between groups using the Mann-Whitney U test or paired t-test as appropriate. Safety will be assessed by the incidence and severity of adverse events. All statistical analyses will be conducted using SPSS 22.0, R software, and GraphPad Prism 8. The study is planned to last 3 years to evaluate treatment response and long-term outcomes of patients.
Newly diagnosed acute myeloid leukemia (AML, excluding AML-M3)
Low-risk or intermediate-risk AML per the 2022 European Leukemia Net (ELN) genetic risk stratification guidelines
Aged 18 to 65 years (inclusive)
Induction chemotherapy with the HAA regimen. For patients diagnosed with AML harboring FLT3-ITD mutation, treatment with the HAA regimen combined with the FLT3 inhibitor Sorafenib is permitted.
Non-remission acute leukemia
Hypersensitivity to N-Acetylcysteine (NAC) or a history of bronchial asthma
Expected survival of less than 30 days after the end of chemotherapy
Uncontrolled infection prior to treatment
Parallel
N-acetyl-L-cysteine (NAC)
DrugN-Acetyl-L-cysteine (NAC) 400 mg oral tablet, three times daily for 28 consecutive days, administered in addition to standard post-induction chemotherapy care for acute myeloid leukemia
Time to Platelet Recovery
The time from Day 1 of chemotherapy until the first day that the platelet count reaches ≥20×10⁹/L and remains stable for 7 consecutive days without transfusion support.
Time to Neutrophil Recovery
The time from Day 1 of chemotherapy until the first day that the absolute neutrophil count (ANC) reaches ≥0.5×10⁹/L for 3 consecutive days, or the white blood cell (WBC) count reaches ≥1.0×10⁹/L for 3 consecutive days
Total Dose of G-CSF
The total dose of Granulocyte Colony-Stimulating Factor (G-CSF) administered, calculated at a starting dose of 5 µg/kg body weight when the WBC count is \<0.5×10⁹/L, until neutrophil recovery is achieved
Total Volume of Platelet Transfusions
The total volume of platelet transfusions administered after the initiation of chemotherapy, when the platelet count is \<10×10⁹/L
Total Volume of Red Blood Cell
The total volume of red blood cell transfusions administered after the initiation of chemotherapy, when the hemoglobin level is \<70 g/L
Exploratory objectives
To evaluate the influence of NAC in the bone marrow microenvironment among patients with AML after chemotherapy
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