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

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06024031
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: N-acetyl-L-cysteine	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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)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)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: N-acetyl-L-cysteine for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy--a Prospective Single-arm Clinical Study
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAC group 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.	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.; Other Names: NAC (Yiweishi)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. overall survival [Participants will be followed for 1 year post diagnosed]

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

4. 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.

Other Outcome Measures

1. Endothelial progenitor cells [Participants will be followed for 1-month post induction chemothrapy]

   Bone marrow microenvironment was evaluated before and after chemotherapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yuan Kong	Beijing	Beijing	China	100032

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

• Principal Investigator: Xiao-Jun Huang, MD, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiao-Jun Huang, Professor, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT06024031
• Other Study ID Numbers: NAC for hematopoietic recovery
• First Posted: Sep 5, 2023
• Last Update Posted: Sep 5, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Acetylcysteine; N-monoacetylcystine

Study Results

No Results Posted as of Sep 5, 2023