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

Phase 2Active Not RecruitingNCT06024031

Peking University People's Hospital30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myeloid Leukemia

Interventions

N-acetyl-L-cysteineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Newly diagnosed AML (except AML-M3) 2. Low-, intermediate risk AML (according to 2022 ELN) 3. Aged 18-60 4. 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% 5. No uncontrolled active infections 6. Sign informed consent form, have the ability to comply with study and follow-up procedures Exclusion Criteria: 1. Hypersensitivity to NAC 2. History of bronchial asthma

Locations (1)

Yuan Kong

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

complete remission rate

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

Time frame: 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

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

overall survival

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

Time frame: 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.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.