Acute Myeloid Leukemia, Adult2026-07-06NCT07869342
NAC for Hematopoietic Recovery in Low/Intermediate-Risk AML After CR: A Randomized Controlled Study
A study testing N-acetyl-L-cysteine (NAC) in people with Acute Myeloid Leukemia, Adult, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Adult
- What is being tested?
- N-acetyl-L-cysteine (NAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 31 Dec 2029
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read more
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
- Being tested
- N-acetyl-L-cysteine (NAC)
- 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-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
| Study group | Role | What they receive |
|---|---|---|
| NAC | Experimental | Intervention Group: N-acetyl-L-cysteine (NAC) plus standard care Receives: Drug: N-acetyl-L-cysteine (NAC) |
| Control | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days post-chemotherapy
Secondary outcomes (9)
Time to Neutrophil Recovery
The time from Day 1 of chemotherapy until the first day that the absolute neutrophil count (ANC) reaches ≥0.5×10⁹/L for 3 consecutive days, or the white blood cell (WBC) count reaches ≥1.0×10⁹/L for 3 consecutive days
Measured: 60 days post-chemotherapy
Total Dose of G-CSF
The total dose of Granulocyte Colony-Stimulating Factor (G-CSF) administered, calculated at a starting dose of 5 µg/kg body weight when the WBC count is <0.5×10⁹/L, until neutrophil recovery is achieved
Measured: 60 days post-chemotherapy
Total Volume of Platelet Transfusions
The total volume of platelet transfusions administered after the initiation of chemotherapy, when the platelet count is <10×10⁹/L
Measured: 60 days post-chemotherapy
Total Volume of Red Blood Cell
The total volume of red blood cell transfusions administered after the initiation of chemotherapy, when the hemoglobin level is <70 g/L
Measured: 60 days post-chemotherapy
Complete Remission (CR) Rate
The proportion of patients achieving a best overall response of Complete Remission (CR) as determined by the investigator per ELN guidelines. CR is defined as: Bone marrow (BM) blasts <5%; no blasts or Auer rods-containing blasts in peripheral blood; no extramedullary disease; Absolute Neutrophil Count (ANC) ≥1.0×10⁹/L; and platelet count ≥100×10⁹/L
Measured: 35 days post chemotherapy
CR + CRi Rate
The proportion of patients achieving a best overall response of Complete Remission (CR) or Complete Remission with incomplete blood count recovery (CRi) as determined by the investigator per ELN guidelines. CRi is defined as: Bone marrow (BM) blasts <5%; no blasts or Auer rods-containing blasts in peripheral blood; no extramedullary disease; ANC <1.0×10⁹/L or platelet count <100×10⁹/L, and transfusion independence
Measured: 35 days post chemotherapy
Overall Survival (OS)
The time from diagnosis to death from any cause
Measured: 24 months post chemotherapy
Relapse-Free Survival (RFS)
The time from achieving Complete Remission (CR) until relapse or death from any cause, while maintaining continuous CR status
Measured: 24 months post CR
Adverse Events
Adverse events related to oral NAC administration, including hepatic function, renal function, or respiratory syndrome evaluated according to the CTCAE version 4.0
Measured: 30 days after the last dose of NAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, AdultStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiao-Jun Huang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869342
- Sponsor's protocol ID
- NAC for AML
- Acronym
- 2026-07-06
- Status last verified
- Oct 2026
- First submitted
- 29 Mar 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07869342
- Acronym / sponsor ID
- 2026-07-06 / NAC for AML
- Conditions
- Acute Myeloid Leukemia, Adult
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC | Experimental | Drug: N-acetyl-L-cysteine (NAC)Intervention Group: N-acetyl-L-cysteine (NAC) plus standard care |
| Control | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl-L-cysteine (NAC)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 | Drug | NAC |
Primary outcome
Time to Platelet Recovery
Time frame: 60 days post-chemotherapy
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.
9 secondary outcomes
Time to Neutrophil Recovery
Time frame: 60 days post-chemotherapy
Total Dose of G-CSF
Time frame: 60 days post-chemotherapy
Total Volume of Platelet Transfusions
Time frame: 60 days post-chemotherapy
Total Volume of Red Blood Cell
Time frame: 60 days post-chemotherapy
Complete Remission (CR) Rate
Time frame: 35 days post chemotherapy
CR + CRi Rate
Time frame: 35 days post chemotherapy
Overall Survival (OS)
Time frame: 24 months post chemotherapy
Relapse-Free Survival (RFS)
Time frame: 24 months post CR
Adverse Events
Time frame: 30 days after the last dose of NAC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao-Jun Huang principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing N-acetyl-L-cysteine (NAC) in people with Acute Myeloid Leukemia, Adult, run by Peking University People's Hospital.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Contact Xiao-Jun Huang (+861088326006, xjhrm@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Platelet Recovery (time frame: 60 days post-chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2026.