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NCT Number: NCT06024031

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yuan Kong

Beijing, Beijing Municipality, 100032, China

About this study

Hematopoietic recovery after chemotherapy is an important factor affecting the prognosis of acute myeloid leukemia. A previous clinical prospective cohort study showed that NAC could improve the function of bone marrow endothelial progenitor cells after chemotherapy, without affecting leukemia cells. Previous animal models have found that chemotherapy can reverse the function of bone marrow endothelial cells in classic AML mice. NAC promotes hematopoietic recovery in AML mice by improving the bone marrow endothelial cells reversed by chemotherapy. Therefore, we hypothesized that the prophylactic administration of NAC after chemotherapy could facilitate the recovery of hematopoietic capacity by improving the bone marrow microenvironment of patients with AML.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Hypersensitivity to NAC
  • History of bronchial asthma

Treatment and study plan

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.

Other names: NAC (Yiweishi)

Primary outcomes

  1. Time to hematopoietic recovery post chemotherapy

    Time frame: Participants will be followed for 2 months post induction 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.

Secondary outcomes

  1. complete remission rate

    Time frame: Participants will be followed for 1 year post induction chemotherapy

    Number of participants with complete remission will be calculated at 1-month post induction chemotherapy

  2. relapse-free survival

    Time frame: Participants will be followed for 1 year post induction chemotherapy

    Number of participants with morphologic relapse will be calculated at one year post Number of participants with morphologic relapse will be calculated at one year post-HSCT

  3. overall survival

    Time frame: Participants will be followed for 1 year post diagnosed

    Number of participants survived for 1 year post diagnosed will be calculated.

  4. Adverse reactions

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

    Liver function, renal function, respiratory syndrom assessed by CTCAE v4.0 during oral administration of NAC.

Other outcomes

  1. Endothelial progenitor cells

    Time frame: Participants will be followed for 1-month post induction chemothrapy

    Bone marrow microenvironment was evaluated before and after chemotherapy

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

N-acetyl-L-cysteine for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy--a Prospective Single-arm Clinical Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 5, 2023
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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