NCT07869342Not yet recruiting
NAC for Hematopoietic Recovery in Low/Intermediate-Risk AML After CR: A Randomized Controlled Study
A Prospective, Single-Center, Randomized Controlled Clinical Study on N-Acetyl-L-Cysteine Promoting Hematopoietic Recovery in Patients With Newly Diagnosed Low/Intermediate-Risk Acute Myeloid Leukemia After Complete Remission
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 29 Mar 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07869342
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Oct 2026 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Expected survival of less than 30 days after the end of chemotherapy
- Uncontrolled infection prior to treatment
Other illness
- Hypersensitivity to N-Acetylcysteine (NAC) or a history of bronchial asthma
- Cardiac dysfunction (specifically congestive heart failure, unstable coronary artery disease, or severe ventricular arrhythmia requiring antiarrhythmic therapy)
- Respiratory failure (arterial partial pressure of oxygen PaO₂ ≤ 60 mmHg)
- Any other condition unsuitable for trial participation (determined by the investigator)
Lab values
- Hepatic abnormality: Total serum total bilirubin ≥ 2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2 times ULN
- Renal abnormality: Serum creatinine ≥ 1.5 times ULN, or creatinine clearance \< 30 mL/min
Other
- Non-remission acute leukemia
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
Who the study is looking for
- 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.
- No severe organ dysfunction
- No uncontrolled active infection
- Signed informed consent, and capable of adhering to study procedures and follow-up protocols
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.