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

Peking University

Status and phase: Active, not recruiting; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: N-acetyl-L-cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT06024031

NAC for hematopoietic recovery

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NAC group

Experimental group

Description:

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.

Treatment:

Drug: N-acetyl-L-cysteine