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Acute Myeloid LeukemiaPhase 2NCT06024031

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

A Phase 2 study testing N-acetyl-L-cysteine in people with Acute Myeloid Leukemia, run by Peking University People's Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
N-acetyl-L-cysteine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
10 Sep 2023to 1 Sep 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Hypersensitivity to NAC
  • History of bronchial asthma

Trial locations and contacts

1 site in 1 country.

China1 site

  • Yuan Kong

    Beijing, Beijing Municipality, 100032

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
N-acetyl-L-cysteine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-acetyl-L-cysteineDrug

    Also called NAC (Yiweishi)

    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.

Study groups in NCT06024031
Study groupRoleWhat they receive
NAC groupExperimentalLow, 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.
Receives: Drug: N-acetyl-L-cysteine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Participants will be followed for 2 months post induction chemotherapy

Secondary outcomes (4)

  1. complete remission rate

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

    Measured: Participants will be followed for 1 year post induction chemotherapy

  2. relapse-free survival

    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

    Measured: Participants will be followed for 1 year post induction chemotherapy

  3. overall survival

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

    Measured: Participants will be followed for 1 year post diagnosed

  4. Adverse reactions

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2023
  2. Study start10 Sep 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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)
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06024031
Sponsor's protocol ID
NAC for hematopoietic recovery
Status last verified
Nov 2024
First submitted
24 Aug 2023
Last updated
7 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40403956

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-acetyl-L-cysteine in people with Acute Myeloid Leukemia, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to hematopoietic recovery post chemotherapy (time frame: Participants will be followed for 2 months post induction chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06024031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.

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