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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetyl-L-cysteine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| relapse-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial progenitor cells | Bone marrow microenvironment was evaluated before and after chemotherapy | Participants will be followed for 1-month post induction chemothrapy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jun Huang, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuan Kong | Beijing | Beijing Municipality | 100032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40403956 | Derived | Hu LJ, Li CY, Xing T, Wang Y, Jiang Q, Jiang H, Wang J, Tang FF, Chang YJ, Zhang XH, Kong Y, Huang XJ. N-acetyl-L-cysteine promoted hematopoietic recovery in patients with acute myeloid leukemia after complete remission--A pilot study. Cancer Lett. 2025 Aug 10;625:217812. doi: 10.1016/j.canlet.2025.217812. Epub 2025 May 20. |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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)
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|
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 |
| overall survival | Number of participants survived for 1 year post diagnosed will be calculated. | Participants will be followed for 1 year post diagnosed |
| 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. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |