[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659815":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":52,"studyPopulation":52,"armGroups":56,"interventions":67,"overallOfficials":73,"centralContacts":77,"locations":52,"responsibleParty":85,"collaborators":52,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":52,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":52,"overallStatus":107,"whyStopped":52,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":52},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Time to Platelet Recovery","The time from Day 1 of chemotherapy until the first day that the platelet count reaches ≥20×10⁹\u002FL and remains stable for 7 consecutive days without transfusion support.","60 days post-chemotherapy",[14,17,20,23,26,30,33,37,41],{"measure":15,"description":16,"timeFrame":12},"Time to Neutrophil Recovery","The time from Day 1 of chemotherapy until the first day that the absolute neutrophil count (ANC) reaches ≥0.5×10⁹\u002FL for 3 consecutive days, or the white blood cell (WBC) count reaches ≥1.0×10⁹\u002FL for 3 consecutive days",{"measure":18,"description":19,"timeFrame":12},"Total Dose of G-CSF","The total dose of Granulocyte Colony-Stimulating Factor (G-CSF) administered, calculated at a starting dose of 5 µg\u002Fkg body weight when the WBC count is \\\u003C0.5×10⁹\u002FL, until neutrophil recovery is achieved",{"measure":21,"description":22,"timeFrame":12},"Total Volume of Platelet Transfusions","The total volume of platelet transfusions administered after the initiation of chemotherapy, when the platelet count is \\\u003C10×10⁹\u002FL",{"measure":24,"description":25,"timeFrame":12},"Total Volume of Red Blood Cell","The total volume of red blood cell transfusions administered after the initiation of chemotherapy, when the hemoglobin level is \\\u003C70 g\u002FL",{"measure":27,"description":28,"timeFrame":29},"Complete Remission (CR) Rate","The proportion of patients achieving a best overall response of Complete Remission (CR) as determined by the investigator per ELN guidelines. CR is defined as: Bone marrow (BM) blasts \\\u003C5%; no blasts or Auer rods-containing blasts in peripheral blood; no extramedullary disease; Absolute Neutrophil Count (ANC) ≥1.0×10⁹\u002FL; and platelet count ≥100×10⁹\u002FL","35 days post chemotherapy",{"measure":31,"description":32,"timeFrame":29},"CR + CRi Rate","The proportion of patients achieving a best overall response of Complete Remission (CR) or Complete Remission with incomplete blood count recovery (CRi) as determined by the investigator per ELN guidelines. CRi is defined as: Bone marrow (BM) blasts \\\u003C5%; no blasts or Auer rods-containing blasts in peripheral blood; no extramedullary disease; ANC \\\u003C1.0×10⁹\u002FL or platelet count \\\u003C100×10⁹\u002FL, and transfusion independence",{"measure":34,"description":35,"timeFrame":36},"Overall Survival (OS)","The time from diagnosis to death from any cause","24 months post chemotherapy",{"measure":38,"description":39,"timeFrame":40},"Relapse-Free Survival (RFS)","The time from achieving Complete Remission (CR) until relapse or death from any cause, while maintaining continuous CR status","24 months post CR",{"measure":42,"description":43,"timeFrame":44},"Adverse Events","Adverse events related to oral NAC administration, including hepatic function, renal function, or respiratory syndrome evaluated according to the CTCAE version 4.0","30 days after the last dose of NAC",[46],{"measure":47,"description":48,"timeFrame":12},"Exploratory objectives","To evaluate the influence of NAC in the bone marrow microenvironment among patients with AML after chemotherapy",{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":52,"timePerspective":52,"maskingInfo":54},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":55,"maskingDescription":52,"whoMasked":52},"NONE",[57,63],{"label":58,"type":59,"description":60,"interventionNames":61},"NAC","EXPERIMENTAL","Intervention Group: N-acetyl-L-cysteine (NAC) plus standard care",[62],"Drug: N-acetyl-L-cysteine (NAC)",{"label":64,"type":65,"description":66,"interventionNames":52},"Control","NO_INTERVENTION","Control Group",[68],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":52},"DRUG","N-acetyl-L-cysteine (NAC)","N-Acetyl-L-cysteine (NAC) 400 mg oral tablet, three times daily for 28 consecutive days, administered in addition to standard post-induction chemotherapy care for acute myeloid leukemia",[58],[74],{"name":75,"affiliation":5,"role":76},"Xiao-Jun Huang","PRINCIPAL_INVESTIGATOR",[78,82],{"name":75,"role":79,"phone":80,"phoneExt":52,"email":81},"CONTACT","+861088326006","xjhrm@medmail.com.cn",{"name":83,"role":79,"phone":80,"phoneExt":52,"email":84},"Li-Juan Hu","hulijuan3619@163.com",{"type":76,"investigatorFullName":75,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Director of hematology, Peking University People's Hospital","100659815","nac-for-hematopoietic-recovery-in-lowintermediate-risk-aml-after-cr-a-randomized-controlled-study-100659815",false,"NCT07869342","NAC for Hematopoietic Recovery in Low\u002FIntermediate-Risk AML After CR: A Randomized Controlled Study","A Prospective, Single-Center, Randomized Controlled Clinical Study on N-Acetyl-L-Cysteine Promoting Hematopoietic Recovery in Patients With Newly Diagnosed Low\u002FIntermediate-Risk Acute Myeloid Leukemia After Complete Remission","2026-07-06","Inclusion Criteria:\n\n1. Newly diagnosed acute myeloid leukemia (AML, excluding AML-M3)\n2. Low-risk or intermediate-risk AML per the 2022 European Leukemia Net (ELN) genetic risk stratification guidelines\n3. Aged 18 to 65 years (inclusive)\n4. Induction chemotherapy with the HAA regimen. For patients diagnosed with AML harboring FLT3-ITD mutation, treatment with the HAA regimen combined with the FLT3 inhibitor Sorafenib is permitted.\n5. No severe organ dysfunction\n6. No uncontrolled active infection\n7. Signed informed consent, and capable of adhering to study procedures and follow-up protocols\n\nExclusion Criteria:\n\n1. Non-remission acute leukemia\n2. Hypersensitivity to N-Acetylcysteine (NAC) or a history of bronchial asthma\n3. Expected survival of less than 30 days after the end of chemotherapy\n4. Uncontrolled infection prior to treatment\n5. Cardiac dysfunction (specifically congestive heart failure, unstable coronary artery disease, or severe ventricular arrhythmia requiring antiarrhythmic therapy)\n6. Respiratory failure (arterial partial pressure of oxygen PaO₂ ≤ 60 mmHg)\n7. Hepatic abnormality: Total serum total bilirubin ≥ 2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≥ 2 times ULN\n8. Renal abnormality: Serum creatinine ≥ 1.5 times ULN, or creatinine clearance \\\u003C 30 mL\u002Fmin\n9. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3\n10. Any other condition unsuitable for trial participation (determined by the investigator)","ALL","18 Years","65 Years",{"count":99,"type":100},180,"ESTIMATED","INTERVENTIONAL",[103],"NA","This prospective, single-center, randomized controlled clinical trial aims to evaluate whether N-acetyl-L-cysteine (NAC) can promote hematopoietic recovery after chemotherapy in patients with acute myeloid leukemia (AML), and to explore its effects on disease remission and bone marrow microenvironment.\n\nEligible participants are newly diagnosed low- or intermediate-risk AML patients aged 18-65 years, with no severe organ dysfunction or active infection. After completing induction chemotherapy with the HAA regimen, subjects will be randomly assigned in a 1:1 ratio to receive either NAC (400 mg orally three times daily for 28 days) plus standard care (intervention group) or standard care alone (control group). A total of 180 patients will be enrolled, with 90 patients in each group.\n\nThe primary endpoint is the time to platelet recovery, defined as the number of days from the first day of chemotherapy until the first day that platelet count reaches ≥20×10⁹\u002FL and remains stable for 7 consecutive days without transfusion support. Secondary endpoints include time to neutrophil recovery, total dose of G-CSF administered, total volume of red blood cell and platelet transfusions, complete remission rate, relapse-free survival, overall survival, and adverse events.\n\nThe primary efficacy analysis will be performed in the intention-to-treat (ITT) population. Continuous variables will be compared between groups using the Mann-Whitney U test or paired t-test as appropriate. Safety will be assessed by the incidence and severity of adverse events. All statistical analyses will be conducted using SPSS 22.0, R software, and GraphPad Prism 8. The study is planned to last 3 years to evaluate treatment response and long-term outcomes of patients.",[106],"Acute Myeloid Leukemia, Adult","NOT_YET_RECRUITING","2026-10-07",{"date":110,"type":111},"2026-10-09","ACTUAL",{"date":113,"type":100},"2026-10",{"date":115,"type":100},"2029-12-31",{"name":5,"class":6}]