Clinical trial NCT06024031: NAC for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy
Official title: N-acetyl-L-cysteine for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy--a Prospective Single-arm Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to hematopoietic recovery post chemotherapy
timeFrame: Participants will be followed for 2 months post induction chemotherapy
Secondary outcomes:
measure: complete remission rate
timeFrame: Participants will be followed for 1 year post induction chemotherapy
measure: relapse-free survival
timeFrame: Participants will be followed for 1 year post induction chemotherapy
measure: overall survival
timeFrame: Participants will be followed for 1 year post diagnosed
measure: Adverse reactions
timeFrame: Participants will be closely observed for NAC-related toxicities during the NAC administration until 1-month post induction chemotherapy.
Other outcomes:
measure: Endothelial progenitor cells
timeFrame: Participants will be followed for 1-month post induction chemothrapy
Locations:
city: Beijing
country: China
facility: Yuan Kong
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Xiao-Jun Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: