An interventional study of N-acetyl-L-cysteine (NAC) in Acute Myeloid Leukemia, Adult, sponsored by Peking University People's Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Supportive care
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.
3,035 studies on the registry are indexed under Leukemia, Myeloid, Acute; 746 are open to participants now.
This study's planned enrollment of 180 is above the median of 40 across 2,561 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Peking University People's Hospital is the lead sponsor of 603 studies on the registry; 241 are open to participants now.
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Exclusion Criteria:
Intervention Group: N-acetyl-L-cysteine (NAC) plus standard care
Drug: N-acetyl-L-cysteine (NAC)
Control Group
N-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 frame: 60 days post-chemotherapy
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
Time frame: 60 days post-chemotherapy
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
Time frame: 60 days post-chemotherapy
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
Time frame: 60 days post-chemotherapy
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
Time frame: 60 days post-chemotherapy
Complete Remission (CR) Rate
The proportion of patients achieving a best overall response of Complete Remission (CR) as determined by the investigator per ELN guidelines. CR is defined as: Bone marrow (BM) blasts \<5%; no blasts or Auer rods-containing blasts in peripheral blood; no extramedullary disease; Absolute Neutrophil Count (ANC) ≥1.0×10⁹/L; and platelet count ≥100×10⁹/L
Time frame: 35 days post chemotherapy
CR + CRi Rate
The proportion of patients achieving a best overall response of Complete Remission (CR) or Complete Remission with incomplete blood count recovery (CRi) as determined by the investigator per ELN guidelines. CRi is defined as: Bone marrow (BM) blasts \<5%; no blasts or Auer rods-containing blasts in peripheral blood; no extramedullary disease; ANC \<1.0×10⁹/L or platelet count \<100×10⁹/L, and transfusion independence
Time frame: 35 days post chemotherapy
Overall Survival (OS)
The time from diagnosis to death from any cause
Time frame: 24 months post chemotherapy
Relapse-Free Survival (RFS)
The time from achieving Complete Remission (CR) until relapse or death from any cause, while maintaining continuous CR status
Time frame: 24 months post CR
Adverse Events
Adverse events related to oral NAC administration, including hepatic function, renal function, or respiratory syndrome evaluated according to the CTCAE version 4.0
Time frame: 30 days after the last dose of NAC
Exploratory objectives
To evaluate the influence of NAC in the bone marrow microenvironment among patients with AML after chemotherapy
Time frame: 60 days post-chemotherapy
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acetylcysteine
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