Acute Myeloid Leukemia
Conditions
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.
Interventions
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endothelial progenitor cells | Participants will be followed for 1-month post induction chemothrapy | Bone marrow microenvironment was evaluated before and after chemotherapy |
Countries
China
Outcome results
None listed