[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"newly-diagnosed-acute-myeloid-leukemia-aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:newly-diagnosed-acute-myeloid-leukemia-aml":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100632534","phase-2-venetoclax-azacitidine-in-combination-with-chidamide-and-cag-in-fit-older-patients-with-acute-myeloid-leukaemia-100632534",false,"NCT07514936","Venetoclax-Azacitidine in Combination With Chidamide and CAG in Fit Older Patients With Acute Myeloid Leukaemia","Venetoclax-Azacitidine in Combination With Chidamide and CAG Versus Daunorubicin and Cytarabine in Fit Older Patients With Acute Myeloid Leukaemia：A Multicenter, Randomized, Controlled, Phase 3 Trial","Inclusion Criteria:\n\n1. Voluntary participation in the clinical study; the subject or legal guardian fully understands and is informed about the study and has signed the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures;\n2. Age between 60-75 years at the time of screening, with no gender restrictions;\n3. Patients are newly diagnosed with AML, and the diagnosis conforms to the standards of the Chinese Medical Association 2021 edition;\n4. No severe allergic constitution;\n5. Liver function: ALT and AST \\\u003C= 2.5 times the upper limit of normal values, bilirubin \\\u003C= 2 times the upper limit of normal values;\n6. Renal function: creatinine \\\u003C= upper limit of normal values;\n7. No uncontrollable infections or severe mental illnesses;\n8. Performance status score is 0-3 (ECOG), with an expected survival of at least 4 months.\n\nExclusion Criteria:\n\n1. Patients who are allergic to the study medication or have contraindications to it;\n2. Pregnant or breastfeeding women;\n3. Patients with active infections;\n4. Patients with long-term smoking or alcohol abuse that could affect the evaluation of trial results;\n5. Patients with mental disorders or other conditions that prevent obtaining informed consent, or who are unable to cooperate with the treatment and examination procedures;\n6. Patients who have undergone major organ surgery within the last 6 weeks;\n7. Abnormal liver function, with total bilirubin \\> 1.5 times the upper limit of normal, ALT\u002FAST \\> 2.5 times the upper limit of normal, or liver-infiltrated patients with ALT\u002FAST \\> 5 times the upper limit of normal; abnormal renal function, with serum creatinine \\> 1.5 times the upper limit of normal;\n8. Patients whom the investigator deems unsuitable for this clinical trial (e.g., poor compliance, drug abuse, etc.).","ALL","60 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a multicenter, prospective, randomized, controlled clinical trial, observing the efficacy and safety of the CACAG+Venetoclax regimen (Chidamide + Azacitidine + Aclarubicin + Cytarabine + Recombinant Human Granulocyte Colony-Stimulating Factor + Venetoclax) in elderly patients with newly diagnosed Acute Myeloid Leukemia (AML). The control group applies the standard \"3+7\" regimen. The aim is to improve the remission rate of AML patients, reduce the probability of adverse events, and thereby improve patient prognosis and extend patient survival.",[27,28],"Newly Diagnosed Acute Myeloid Leukemia (AML)","Elderly Patients",[28,30,31],"newly diagnosed","Acute Myeloid Leukemia","RECRUITING","2026-06-11",{"date":35,"type":36},"2026-06-15","ACTUAL",{"date":38,"type":36},"2024-11-18",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Chinese PLA General Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100606180","phase-2-alternating-regimen-of-va-and-low-dose-cha-in-the-treatment-of-unfit-newly-diagnosed-aml-100606180","NCT07172204","Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML","The Efficacy and Safety of VA Alternating With Low-dose CHA in the Treatment of Newly Diagnosed Unfit AML: a Prospective, Multi-centers, Single Arm Phase II Study","CHANCE","Inclusion Criteria:\n\n* Understand the research and sign a written informed consent form;\n* Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment;\n* or unwilling to undergo IC. Ineligibility for IC is defined as meeting any of the following criteria:\n* Age ≥ 60 years\n* Age 18-59 years but ineligible for intensive chemotherapy (IC) , meet ≥1 of the following:\n\n  * Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening;\n  * Severe heart failure (congestive heart failure requiring treatment or myocardial infarction history with ejection fraction ≤50%);\n  * Severe pulmonary dysfunction (DLCO ≤65%, FEV1 ≤65%, dyspnea at rest, or oxygen dependence);\n  * Severe renal insufficiency requiring dialysis;\n  * Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin \\>1.5×ULN;\n* Mental illness requiring inpatient psychiatric treatment;\n* Any comorbidity deemed by physician to contraindicate IC.\n\nExclusion Criteria:\n\n* Diagnosis of: AML arising from chronic myeloid leukemia (CML); myeloid sarcoma; acute promyelocytic leukemia (APL) or presence of FLT3-ITD mutations;\n* Active malignancies (except adequately treated carcinoma in situ or basal cell carcinoma) within 2 years prior to Cycle 1 Day 1 (C1D1);\n* Major surgery or systemic anticancer therapy within 28 days before C1D1;\n* Known hypersensitivity to: Active pharmaceutical ingredients: cladribine, homoharringtonine, cytarabine, venetoclax, azacitidine; Any excipients in study drug formulations;\n* GI conditions impairing oral drug absorption: Dysphagia; short-gut syndrome; gastroparesis or related disorders;\n* Uncontrolled active infection;\n* Controlled infection permitted if: Afebrile (\\\u003C38°C) and hemodynamically stable (SBP \\>90 mmHg, HR \\\u003C100 bpm) for ≥72 hours pre-C1D1; on non-interacting antimicrobial regimen; active HBV\u002FHCV infection (Chronic carriers require PI approval with viral load monitoring); HIV-positive patients receiving HAART;\n* Pregnancy\u002Flactation or refusal of contraception: Negative serum β-hCG within 24h pre-C1D1;\n* Psychiatric disorders or social circumstances compromising protocol compliance;\n* Prior AML-directed therapy except: cytoreduction for hyperleukocytosis per institutional guidelines (hydroxyurea, leukapheresis); supportive growth factors;","18 Years",{"count":55,"type":21},25,[24],"This phase II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.",[59,27,60],"Intensive Chemotherapy Unfit","Age ≥60",[31,62,63,64,65,66,67,30],"Venetoclax","alternating","Homoharringtonine","Cladribine","age 60 and older","intensive chemotherapy unfit","2026-02-02",{"date":70,"type":36},"2026-02-04",{"date":72,"type":36},"2025-09-16",{"date":74,"type":21},"2029-07-31",{"name":76,"class":43},"First Affiliated Hospital of Zhejiang University",5,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100473458","phase-1-sklb1028-daunorubicin-and-cytarabine-in-treating-patients-with-newly-diagnosed-acute-myeloid-leukemia-aml-100473458","NCT05445154","SKLB1028, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)","A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I\u002FII Study of SKLB1028 Combined With \"7+3\" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) \\> 20% blasts in the bone marrow according to WHO classification (2016) documented prior to enrollment.;\n2. Age ≥ 18 and \\\u003C 60 years;\n3. Subjects who are positive for FLT3 mutations by central laboratory;\n4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n5. Subject must meet the following criteria as indicated on the clinical laboratory tests;\n\n   1. Serum aspartate aminotransf\n   2. Total serum bilirubin ≤ 2.5 x institutional ULN\n   3. Serum creatinine ≤ 3 x institutional ULN or an estimated glomerular filtration rate (eGFR) of \\> 30 ml\u002Fmin\n6. Subject is suitable for oral administration of study drug.\n\nExclusion Criteria:\n\n1. Confirmed diagnosis of acute promyelocytic leukemia (M3 \u002FAPL), or BCR-ABL positive leukemia (ie, blast crisis of chronic myelogenous leukemia);\n2. Diagnosis of active malignancy other than AML;\n3. AML secondary to radiotherapy or chemotherapy for other tumors;\n4. AML with central nervous system involvement;\n5. Refractory hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and that occurs repeatedly in the past;\n6. Current clinically significant graft-ve\n7. Previous history of other malignancies.\n8. Patients with clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and von Willebrand disease;\n9. Major surgery of major organs has been performed before entering the study (for the definition of major surgery, refer to Grade 3 and 4 surgery specified in Management Measures for Clinical Application of Medical Technology, or the patient has not yet fully recovered from\n10. Subject has received prior therapy for AML with the following exceptions: a. emergency leukapheresis; b. emergency treatment with hydroxyurea ;c. growth factor or cytokine support; d. steroid for anaphylaxis or transfusion reaction;","59 Years",{"count":87,"type":21},58,[89,24],"PHASE1","The purpose of this study is to describe the dose limiting toxicities (DLT) of SKLB1028 when combined with cytarabine\u002F daunorubicin remission induction in a 7+3 schedule. Safety and tolerability of SKLB1028 will also be evaluated. This study will also characterize the pharmacokinetics (PK) of SKLB1028 when given in combination with cytarabine\u002Fdaunorubicin remission induction and high-dose cytarabine (HiDAC) consolidation therapy in newly diagnosed acute myeloid leukemia .",[27],"2022-06-30",{"date":94,"type":36},"2022-07-06",{"date":96,"type":36},"2021-08-31",{"date":98,"type":21},"2026-12-31",{"name":100,"class":101},"CSPC ZhongQi Pharmaceutical Technology Co., Ltd.","INDUSTRY"]