NAC for Hematopoietic Recovery in Low/Intermediate-Risk AML After CR: A Randomized Controlled Study

NCT07869342 | Not Yet Recruiting DMC

• 1 other identifier: NAC for AML
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Myeloid Leukemia, Adult

Outcome Measures

Primary Outcomes (1)

• 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.

  60 days post-chemotherapy

Secondary Outcomes (9)

• Time to Neutrophil Recovery

  60 days post-chemotherapy

• Total Dose of G-CSF

  60 days post-chemotherapy

• Total Volume of Platelet Transfusions

  60 days post-chemotherapy

• Total Volume of Red Blood Cell

  60 days post-chemotherapy

• Complete Remission (CR) Rate

  35 days post chemotherapy

Other Outcomes (1)

• Exploratory objectives

  60 days post-chemotherapy

Study Arms (2)

NAC

EXPERIMENTAL

Intervention Group: N-acetyl-L-cysteine (NAC) plus standard care

Drug: N-acetyl-L-cysteine (NAC)

Control

NO INTERVENTION

Control Group

Interventions

N-acetyl-L-cysteine (NAC) DRUG

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

NAC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3
• Any other condition unsuitable for trial participation (determined by the investigator)

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Xiao-Jun Huang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-Jun Huang

CONTACT

+861088326006; xjhrm@medmail.com.cn

Li-Juan Hu

CONTACT

+861088326006; hulijuan3619@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of hematology, Peking University People's Hospital

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share