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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024031
• Other study ID #: NAC for hematopoietic recovery
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2023
• Source: Peking University People's Hospital
• Contact: Xiao-Jun Huang, MD
• Phone: +861088326006
• Email: xjhrm[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• N-acetyl-L-cysteine
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.

Locations

Country	Name	City	State
China	Yuan Kong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial progenitor cells	Bone marrow microenvironment was evaluated before and after chemotherapy	Participants will be followed for 1-month post induction chemothrapy
Primary	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	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
Secondary	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
Secondary	overall survival	Number of participants survived for 1 year post diagnosed will be calculated.	Participants will be followed for 1 year post diagnosed
Secondary	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.