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

Phase 2

Active, not recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: N-acetyl-L-cysteine

• Registration Number: NCT06024031
• Lead Sponsor: Peking University People's Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-05
• Study Start: 2023-09-10
• Primary Completion: 2024-09-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAC group	N-acetyl-L-cysteine	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.

Primary Outcome Measures

Name	Time	Method
Time to hematopoietic recovery post chemotherapy	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 Outcome Measures

Name	Time	Method
complete remission rate	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
relapse-free survival	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
overall survival	Participants will be followed for 1 year post diagnosed	Number of participants survived for 1 year post diagnosed will be calculated.
Adverse reactions	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.

Trial Locations

Locations (1)

Yuan Kong; 🇨🇳 Beijing, Beijing, China