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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: N-acetyl-L-cysteine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAC group<br>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<br>* 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.<br>* Other names: NAC (Yiweishi);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | Number of participants with complete remission will be calculated at 1-month post induction chemotherapy | Participants will be followed for 1 year post induction chemotherapy | 
| 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 | Participants will be followed for 1 year post induction chemotherapy | 
| overall survival | Number of participants survived for 1 year post diagnosed will be calculated. | Participants will be followed for 1 year post diagnosed | 
| Adverse reactions | Liver function, renal function, respiratory syndrom assessed by CTCAE v4.0 during oral administration of NAC. | Participants will be closely observed for NAC-related toxicities during the NAC administration until 1-month post induction chemotherapy. |