[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adult-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adult-acute-myeloid-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,75,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100472265","phase-3-mocravimod-as-adjunctive-and-maintenance-treatment-in-aml-patients-undergoing-allo-hct-100472265",false,"NCT05429632","Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT","Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Mocravimod as Adjunctive and Maintenance Treatment in Adult AML Patients Undergoing Allogeneic HCT","MO-TRANS","Inclusion Criteria:\n\n* Diagnosis of AML (excluding acute promyelocytic leukemia) according to the WHO 2022 classification of AML and related precursor neoplasm, including AML with myelodysplasia-related gene mutations\n* European Leukemia Net (ELN) high-risk or intermediate-risk AML in CR1, or AML of any risk in CR2, \\[CRi\\] is also allowable\n* Planned allogeneic HCT from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using PBSC graft\n* Any conditioning regimen with a Transplant Conditioning Score (TCI) ≥ 1.5\n* Planned use of TAC-based GvHD prophylaxis\n* age ≥ 18 years and ≤ 75 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Use of CsA, anti-thymocyte globulin (ATG), alemtuzumab, abatacept for GvHD prophylaxis\n* Diagnosis of macular edema during screening\n* Cardiac\u002Fpulmonary\u002Fhepatic\u002Frenal dysfunction\n* Hepatic dysfunction as defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN); or total bilirubin \\> 1.5 mg\u002FdL\n* Renal dysfunction with estimated creatinine clearance \\\u003C 45 mL\u002Fmin by the Cockcroft-Gault formula\n\n  * Diabetes mellitus\n  * History or presence of uveitis at screening\n  * History or diagnosis of macular edema","ALL","18 Years","75 Years",{"count":21,"type":22},366,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a multi-center, randomized, double-blinded, placebo controlled trial.",[28],"Adult Acute Myeloid Leukemia","RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":33},"2022-06-16",{"date":37,"type":22},"2029-11",{"name":39,"class":40},"Priothera SAS","INDUSTRY",110,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100594054","phase-1-clinical-trial-of-wbc100-capsule-in-relapsedrefractory-acute-myeloid-leukemia-100594054","NCT07014449","Clinical Trial of WBC100 Capsule in Relapsed\u002FRefractory Acute Myeloid Leukemia","An Open-Label, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WBC100 Capsules in Patients With Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Signed informed consent and compliance with study procedures;\n* 2\\. Male or female participants aged ≥18 years at the time of consent;\n* 3\\. Diagnosis of relapsed or refractory acute myeloid leukemia (R\u002FR AML) according to the 2016 World Health Organization (WHO) classification;\n* 4\\. ECOG PS 0-2;\n* 5\\. Life expectancy ≥3 months;\n* 6\\. Adequate bone marrow reserve and organ function as defined below:\n\n  1. Bone marrow reserve: Peripheral WBC \\\u003C 25 × 10⁹\u002FL (leukocyte-reducing agents are allowed, with a washout period of at least 5 half-lives prior to study drug administration);\n  2. Coagulation: International normalized ratio (INR) ≤ 2;\n  3. Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN. In cases of hepatic involvement: ALT or AST ≤ 5 × ULN, and TBIL ≤ 3 × ULN;\n  4. Renal function: Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN;\n  5. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤450 ms for males, ≤470 ms for females.\n* 7\\. Female participants of childbearing potential and fertile male participants with partners of childbearing potential must use medically approved contraception during treatment and for 6 months after the final dose.\n\nExclusion Criteria:\n\n* 1\\. Known hypersensitivity to WBC100 capsules or any of their excipients;\n* 2\\. Diagnosis of acute promyelocytic leukemia (APL);\n* 3\\. Diagnosis of mixed phenotype acute leukemia, chronic myeloid leukemia in blast crisis, or AML transformed from myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN);\n* 4\\. Subjects with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT within the past 90 days;\n* 5\\. Subjects who have undergone major surgery, have active ulcers, or have unhealed wounds within 28 days prior to the first dose;\n* 6\\. Received other investigational drugs or treatments within 28 days prior to the first administration, or are still within the safety follow-up period of another clinical trial;\n* 7\\. Subjects with a history of severe cardiovascular or cerebrovascular conditions, including but not limited to:\n\n  1. Significant arrhythmias or conduction disorders (e.g., ventricular arrhythmias, Grade II-III AV block);\n  2. Thromboembolic events requiring anticoagulation or presence of vena cava filter;\n  3. NYHA Class III-IV heart failure;\n  4. Poorly controlled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite treatment).\n* 8\\. Evidence of severe or uncontrolled systemic diseases, such as refractory effusions, poorly controlled diabetes, or significant disorders of the psychiatric, neurological, cardiovascular, respiratory, endocrine, gastrointestinal, hepatic, or renal systems;\n* 9\\. History or presence of immunodeficiency, autoimmune disease requiring systemic immunosuppressants, or organ transplantation;\n* 10\\. Congestive heart failure, aortic dissection, stroke (excluding lacunar infarct), unstable angina, myocardial infarction, bypass surgery, or pulmonary embolism within 180 days prior to first dosing;\n* 11\\. Known risk factors for QT prolongation, including congenital long QT syndrome or drug-induced arrhythmia history;\n* 12\\. Positive for syphilis antibodies, HIV, active HBV infection (HBsAg+ or HBcAb+ with HBV DNA ≥1000 IU\u002FmL), or active HCV infection (HCV Ab+ with detectable HCV RNA);\n* 13\\. Active infection requiring systemic treatment, including uncontrolled bacterial, viral, or fungal infections;\n* 14\\. Gastrointestinal conditions preventing oral drug intake or absorption, such as severe vomiting, chronic diarrhea, intestinal stoma, malabsorption, or inability to swallow;\n* 15\\. Use of strong CYP450 inhibitors\u002Finducers that cannot be stopped ≥7 days before dosing;\n* 16\\. Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days;\n* 17\\. Receipt of any live or attenuated vaccines (e.g., influenza, varicella) within 28 days;\n* 18\\. History of other malignancies within 2 years, except adequately treated basal cell carcinoma, carcinoma in situ of cervix or breast, or squamous cell carcinoma of the skin;\n* 19\\. History of psychiatric or neurological disorders that may interfere with protocol compliance;\n* 20\\. Inability to tolerate venous blood draws;\n* 21\\. Pregnant or breastfeeding women, or women with positive serum hCG during screening;\n* 22\\. Any condition deemed by the investigator to make the subject unsuitable for study participation.",{"count":50,"type":22},18,[52],"PHASE1","The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia (R\u002FR AML). The main questions it aims to answer are:\n\n* What is the safety and tolerability profile of WBC100 in R\u002FR AML patients?\n* Can WBC100 effectively induce remission in R\u002FR AML patients?\n\nParticipants will:\n\n* Take WBC100 capsules orally once daily in 28-day treatment cycles;\n* Undergo regular safety assessments, including adverse event monitoring and laboratory tests;\n* Provide blood samples for pharmacokinetic (PK) analysis;\n* Have their remission status and efficacy evaluated according to the ELN2022 criteria.",[55,56,57,58,59,28],"AML (Acute Myelogenous Leukemia","Relapsed Acute Myelogenous Leukemia","Refractory Acute Myeloid Leukemia","Hematologic Malignancy","C-Myc",[61,62,63,64],"c-Myc","Molecular glue","Acute Myelogenous Leukemia","Relapsed and Refractory Acute Myelogenous Leukemia","2025-06-02",{"date":67,"type":33},"2025-06-11",{"date":69,"type":33},"2024-11-03",{"date":71,"type":22},"2026-06",{"name":73,"class":40},"Hangzhou Weben Pharma Co., Ltd",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":74},"100519612","relation-between-venetoclax-plasma-concentration-and-remission-in-adults-with-acute-myeloid-leukemia-prediclax-100519612","NCT06045819","Relation Between Venetoclax Plasma Concentration and Remission in Adults with Acute Myeloid Leukemia (PREDICLAX)","Study of the Association Between Residual Venetoclax Plasma Concentration and Composite Complete Remission in Adults with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy (PREDICLAX)","Inclusion Criteria:\n\n1. Subject must have a confirmed diagnosis of previously untreated AML (ELN 2022 criteria) within 28 days of the onset of symptoms. Only previous cytoreductive treatments (e.g. hydroxyurea) are authorized.\n2. Subject must be ineligible for standard cytarabine and anthracycline induction therapy according to the following criteria:\n\n   * Subject aged ≥ 75 years.\n   * OR subject aged between 60 and 74 with at least one of the following comorbidities:\n\n     * ECOG performance status: of 2 or 3.\n     * cardiac history: heart failure requiring treatment, left ventricular ejection fraction ≤ 50%, chronic stable angina.\n     * carbon monoxide diffusion capacity ≤ 65% or forced expiratory volume in one second ≤ 65%.\n     * creatinine clearance between 30 and 45 mL\u002Fmin\u002Fm².\n     * liver damage (not related to AML) with total bilirubin between 1.5 and 3 × upper normal limit.\n     * any other comorbidity deemed by the physician to be incompatible with standard induction chemotherapy.\n3. Patients are eligible for the recommended standard treatment, i.e. a combination of venetoclax and a hypomethylating agent.\n4. Subjects must voluntarily sign and date an informed consent form authorized by the relevant authorities.\n5. The participation of the subject in another interventional study not interfering with the pathophysiological, pharmacological and clinical rationale of this protocol is possible.\n\nExclusion Criteria:\n\n1. blood leukocytes \\>25 G\u002FL.\n2. Subject has already received anticancer treatment (drugs, surgery, radiotherapy) for AML, hematological malignancy or malignant cancer (within the last 2 years).\n3. Subjects with AML with central nervous system involvement or promyelocytic type (AML-M3).\n4. Subject to an uncontrolled intercurrent disease such as:\n\n   * infection (viral, bacterial or fungal) requiring treatment;\n   * symptomatic congestive heart failure;\n   * unstable angina pectoris\n   * cardiac arrhythmia\n   * psychiatric illness or drug addiction that would limit compliance with study requirements (risk of treatment non-adherence or low venous capital).\n5. Documented hypersensitivity to the drugs used to treat the subject.\n6. Subject has been exposed to potent CYP450 inducers or inhibitors (including grapefruit, Seville oranges) within 7 days prior to treatment initiation.","60 Years","90 Years",{"count":85,"type":22},100,"OBSERVATIONAL","Background: In combination with hypomethylating drugs, venetoclax has recently changed the therapeutic management of patients with newly diagnosed acute myeloid leukemia (AML) for whom standard induction chemotherapy was not an option. Over and above the clinical benefits of this combination, the data show that more than half the patients did not show remission criteria, even after the first month's exposure to venetoclax.\n\nHypothesis: To compare the mean residual venetoclax plasma concentrations obtained in patients who went into complete composite remission versus those who did not go into remission at the end of the first cycle of venetoclax + azacitidine treatment.\n\nMethod: According to the French law, this is a multicenter, non-comparative, open-label, single-arm, interventional study with minimal risks and constraints. Selection, information and inclusion will concern adult patients (≥60 years) with a confirmed diagnosis of AML according to ELN 2022 guidelines. Included patients will be treated as standard care with a combination of venetoclax+azacitidine. This research protocol will not modify their usual care.",[28],"2025-02-26",{"date":91,"type":33},"2025-02-28",{"date":93,"type":33},"2024-04-08",{"date":95,"type":22},"2026-01",{"name":97,"class":98},"University Hospital, Caen","OTHER",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":74},"100541448","a-prospective-multicenter-and-exploratory-study-of-cmgv-in-the-treatment-of-recurrent-adult-aml-and-mds-eb-2elder-aml-100541448","NCT06329999","A Prospective, Multicenter, and Exploratory Study of CMGV in the Treatment of Recurrent Adult AML and MDS-EB-2\u002FElder AML","A Prospective, Multicenter, and Exploratory Study of Mitoxantrone Liposomes, Cytarabine and G-CSF Combined With Vineclavone in the Treatment ofRecurrent Adult AML and MDS-EB-2\u002FElder AML","Inclusion Criteria:\n\n* The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);\n* Age: 18-75 years old (including boundary values of 18 and 75);\n* Clinically confirmed adult AML and MDS-IB2 (WHO 2022 standard) patients, AML patients meet any of the following criteria:\n\n  1. Treatment related AML\n  2. Previously had a history of MDS\n  3. Associated with MDS related genes\u002Fchromosomal abnormalities\n  4. Previously had a history of CMML\n  5. Age ≥ 60 years old\n  6. Previous history of prodromal MPN, including ET, PV, and MF, with bone marrow fibrosis ≤ grade 2 (according to the 0-3 grade standard)；\n* For elderly AML or MDS patients, the comprehensive evaluation should be based on the Fit population: ECOG\\\u003C3, no major comorbidities, and MMSE and SPPB meet the standards (refer to Appendix 8-11);\n* Expected survival time ≥ 3 months;\n* Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal value (ULN) (≤ 5 times the upper limit of normal value for patients with liver infiltration); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver infiltration); Serum creatinine ≤ 1.5 times the upper limit of normal value;\n* The relevant treatment for MDS (excluding blood transfusion) must be completed 2 weeks before the start of the study treatment; In the case of rapidly proliferative diseases, hydroxyurea is allowed to be used until 24 hours before the start of the study treatment. Before starting the research treatment,Toxicity related to previous MDS treatment must be restored to level 2 or below.\n\nExclusion Criteria:\n\nThe researchers determined that patients who are not suitable to participate in this study. If a patient meets any of the following criteria, they will not be allowed to enter this study:\n\n* The subject's previous history of anti-tumor treatment meets one of the following conditions:\n\n  1. Individuals who have previously received mitoxantrone or mitoxantrone liposomes;\n  2. Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin\\>360mg\u002Fm2 (1mg of doxorubicin is equivalent to 2mg of doxorubicin or 0.5mg of doxorubicin);\n  3. Within 4 weeks prior to the first use of the study drug or within 5 half-lives of the drug, the patient has received anti-tumor treatment including surgery, chemotherapy, targeted therapy, or participated in other clinical trials and received clinical trial medication;\n* Heart function and disease meet one of the following conditions:\n\n  1. Long QTc syndrome or QTc interval\\>480ms;\n  2. Complete left bundle branch block, II or III degree atrioventricular block;\n  3. Severe and uncontrolled arrhythmias that require medication treatment;\n  4. The New York College of Cardiology in the United States has a classification of ≥ II;\n  5. Cardiac ejection fraction (LVEF) below 50%;\n  6. A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment.\n* Patients who have previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast\u002Fcervical carcinoma in situ, and other malignant tumors that have not been treated for more than 6 months and have been effectively controlled, as well as patients who have received long-term non chemotherapy treatments such as hormone therapy);\n* Uncontrollable systemic diseases (such as infection during the promotion period, uncontrollable hypertension, diabetes, etc.);\n* Central nervous system leukemia;\n* Secondary AML patients with bone marrow fibrosis ≥ grade 3;\n* CML patients with sudden changes;\n* Accompanied by a well prognosis chromosome karyotype t (8; 21) (q22; q22.1) RUNX1:: RUNX1T1, inv (16) (p13.1 q22) CBFB: MYH11, as well as acute promyelocytic leukemia;\n* Human immunodeficiency virus (HIV) infected individuals (HIV antibody positive);\n* Active infection of hepatitis B and hepatitis C (if hepatitis B B surface antigen or core antibody is positive, HBV-DNA will be tested additionally, and if HBV-DNA exceeds 1x103 copies\u002FmL, it will be excluded; if hepatitis C antibody is positive, HCV-RNA will be tested additionally, and if hepatitis C virus RNA exceeds 1x103 copies\u002FmL, it will be excluded);\n* Have a known history of immediate or delayed hypersensitivity reactions to similar drugs and excipients in the study drug;\n* Accompanied by a history of severe neurological or mental illness;\n* The researchers determined that there were patients who were not suitable to participate in this study.",{"count":107,"type":22},78,[109],"NA","The goal of this clinical trial\\] is to evaluate mitoxantrone hydrochloride liposomes, subcutaneous injection of cytarabine and G-CSF combined with Venetoclax (CMG+Ven) in adult secondary acute myeloid leukemia and myelodysplastic syndrome with increased primordial cells type 2(MDS-IB2) or elderly acute myeloid leukemia\\]. The main questions it aims to answer are:\n\n* Evaluation of the efficacy\n* Evaluation of the safety",[112,113,28],"Recurrent Adult Acute Myeloid Leukemia","Myelodysplastic Syndrome",[115,116,117,112,118,28],"Mitoxantrone Hydrochloride Liposomes","Cytarabine","Venetoclax","MDS-EB-2","2024-03-19",{"date":121,"type":33},"2024-03-26",{"date":123,"type":33},"2024-02-03",{"date":125,"type":22},"2027-12-31",{"name":127,"class":98},"Ruijin Hospital"]