NAC for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy

NCT06024031 | Active Not Recruiting Phase 2

• 1 other identifier: NAC for hematopoietic recovery
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective single-arm clinical study to evaluate the role of NAC after chemotherapy among patients with AML can promote hematopoietic recovery and does not affect the remission rate of the leukemia.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Time to hematopoietic recovery post chemotherapy

  Time to hematopoietic recovery (white blood cell \> 1×10\^9/L, platelet \> 20 ×10\^9/L), the dosages of G-CSF, red blood cell transfusion,platelet transfusion.

  Participants will be followed for 2 months post induction chemotherapy

Secondary Outcomes (4)

• complete remission rate

  Participants will be followed for 1 year post induction chemotherapy

• relapse-free survival

  Participants will be followed for 1 year post induction chemotherapy

• overall survival

  Participants will be followed for 1 year post diagnosed

• Adverse reactions

  Participants will be closely observed for NAC-related toxicities during the NAC administration until 1-month post induction chemotherapy.

Other Outcomes (1)

• Endothelial progenitor cells

  Participants will be followed for 1-month post induction chemothrapy

Study Arms (1)

NAC group

EXPERIMENTAL

Low, intermediate risk AML patients were enrolled, and NAC (400mg tid) was administered orally from day1 to day 28 (D1-D28) after the end of induction chemotherapy.

Drug: N-acetyl-L-cysteine

Interventions

N-acetyl-L-cysteine DRUG

N-acetyl-L-cysteine (Yiweishi) capsules (Guangdong Renrenkang Pharmaceutical Industry) will be given orally 400mg three times a day from day 1 to day 28 after chemotherapy. In case of drug allergy such as nausea, vomiting, rash and bronchospasm, and disease relapse, to discontinue the drug immediately.

Also known as: NAC (Yiweishi)

NAC group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Newly diagnosed AML (except AML-M3)
• Low-, intermediate risk AML (according to 2022 ELN)
• Aged 18-60
• No severe organ injury 1) Creatinine \< 1.5mg/dl 2) Hemobilirubin ≤ 1.5 X ULN 3) AST and ALT ≤ 3.0 X ULN 4) Cardiac ejection index ≥ 50%
• No uncontrolled active infections
• Sign informed consent form, have the ability to comply with study and follow-up procedures

You may not qualify if:

• Hypersensitivity to NAC
• History of bronchial asthma

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Yuan Kong

Beijing, Beijing Municipality, 100032, China

Location

Related Publications (1)

• Hu LJ, Li CY, Xing T, Wang Y, Jiang Q, Jiang H, Wang J, Tang FF, Chang YJ, Zhang XH, Kong Y, Huang XJ. N-acetyl-L-cysteine promoted hematopoietic recovery in patients with acute myeloid leukemia after complete remission--A pilot study. Cancer Lett. 2025 Aug 10;625:217812. doi: 10.1016/j.canlet.2025.217812. Epub 2025 May 20.

  PMID: 40403956 DERIVED

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, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: From the first day after the end of chemotherapy: NAC 400mg tid D1-D28 was added on the basis of routine supportive therapy (blood transfusion)

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 5, 2023
• Study Start: September 10, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)