[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml-adult":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,42,72,98,127,149,172,194,216,238,260,288,309,333,356,380,405,426,456,478,501,526,548,573,595],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100624246","phase-3-vag-versus-standard-chemotherapy-with-flt3-inhibitor-in-adult-patients-with-flt3-mutated-aml-100624246",false,"NCT07407140","VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML","A Multicenter, Randomized, Controlled Trial of a Triple-Drug Regimen (Venetoclax, Azacitidine, Gilteritinib) Followed by Intensive Chemotherapy, Versus Standard Chemotherapy Plus Gilteritinib, in Fit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia.","VAG-3+7-G","Inclusion Criteria:\n\n* Newly diagnosed AML (excluding CBF-AML and APL) or MDS\u002FAML (with 10%-20% marrow blasts) per WHO 2022 or ICC criteria\n* Documented FLT3-ITD or FLT3-TKD mutation by PCR or NGS\n* Age ≥14 and \\\u003C75 years\n* Eligible for intensive chemotherapy\n* ECOG performance status 0-2\n* Adequate organ function (liver, kidney, cardiac)\n* Written informed consent\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA\n* Core-binding factor AML (RUNX1-RUNX1T1 or CBFB-MYH11)\n* BCR-ABL positive AML\n* Prior induction chemotherapy for AML (hydroxyurea allowed)\n* Concurrent active malignancy requiring therapy\n* Active\u002Fsymptomatic cardiac disease\n* Severe uncontrolled infection\n* Any condition deemed unsuitable by the investigator","ALL","14 Years","75 Years",{"count":22,"type":23},300,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","This is a multicenter, randomized, controlled, open-label phase III trial evaluating the efficacy and safety of the VAG regimen (azacitidine, venetoclax, and gilteritinib) compared with standard 3+7 chemotherapy (cytarabine plus daunorubicin or idarubicin) combined with gilteritinib in newly diagnosed, fit patients with FLT3-mutated acute myeloid leukemia (AML). A total of 300 patients aged ≥14 to \\\u003C75 years with FLT3-ITD or FLT3-TKD mutations will be enrolled and randomized 1:1 to the experimental or control arm, stratified by age (≤60 vs. \\>60 years). The primary endpoint is event-free survival (EFS). Secondary endpoints include composite complete remission (CRc) rate, minimal residual disease (MRD) negativity rate by flow cytometry and NGS, overall survival (OS), relapse-free survival (RFS), and 30-day and 60-day mortality.",[29],"AML, Adult","NOT_YET_RECRUITING","2026-03-24",{"date":33,"type":34},"2026-03-25","ACTUAL",{"date":36,"type":23},"2026-04-30",{"date":38,"type":23},"2030-12-31",{"name":40,"class":41},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":20,"enrollmentInfo":50,"targetDuration":4,"studyType":24,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100540176","phase-1-revumenib-in-combination-with-73--midostaurin-in-aml-100540176","NCT06313437","Revumenib in Combination With 7+3 + Midostaurin in AML","A Phase I Trial of Revumenib in Combination With 7+3 (7 Days of Cytarabine and 3 Days of Daunorubicin) + Midostaurin Induction Chemotherapy for the Frontline Treatment of NPM1 and FLT3 Mutated AML","Inclusion Criteria:\n\n* Patients with AML who are newly diagnosed according to the WHO 2022 Classification and previously untreated except for hydroxyurea. ATRA pretreatment for suspected APL for less than 5 days is allowed. Eligible patients with AML arising from an antecedent hematologic disease (AHD) including MDS, may have been treated for their prior hematologic disease (except for allogenic transplant).\n* Patients must be ≥ 18 and \\\u003C 75 years old.\n* Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.\n* Presence of FLT3-ITD and\u002For TKD mutation(s) AND NPM1 mutation in bone marrow or peripheral blood\n* Dose escalation phase only: Presence of any of the following adverse risk genetic characteristics:\n\n  * 2022 ELN adverse risk genetic features:\n\n    * t(6;9)(p23.3;q34.1)\u002FDEK::NUP214\n    * t(v;11q23.3)\u002FKMT2A-rearranged\n    * t(9;22)(q34.1;q11.2)\u002FBCR::ABL1\n    * t(8;16)(p11.2;p13.3)\u002FKAT6A::CREBBP\n    * inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)\u002F GATA2, MECOM(EVI1)\n    * t(3q26.2;v)\u002FMECOM(EVI1)-rearranged\n    * -5 or del(5q); -7; -17\u002Fabn(17p)\n    * Complex karyotype, monosomal karyotype\n    * Mutations in either one of these genes: ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n    * Mutated TP53\n  * NPM1 + FLT3-ITD + DNMT3A mutation\n* LVEF ≥ 50% by MUGA or ECHO at screening.\n* Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL\u002Fmin; determined by the Cockcroft Gault formula.\n* Adequate liver function as demonstrated by:\n\n  * aspartate aminotransferase (AST) ≤ 2.5 × ULN\\*\n  * alanine aminotransferase (ALT) ≤ 2.5× ULN\\*\n  * total bilirubin ≤ 1.5 × ULN\\* \\* Unless considered due to leukemic organ involvement. Note: Subjects with Gilbert's Syndrome may have a total bilirubin \\> 1.5 × ULN per discussion with the Sponsor-Investigator\n* Resolution of adverse reactions to prior drug therapy (such as hydroxyurea) to ≤ grade 1\n* Eligible for intensive cytarabine\u002Fdaunorubicin (7+3) chemotherapy based on the opinion of the treating physician.\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.\n* Females of childbearing potential (i.e., not postmenopausal for at least 1 year or not surgically sterile) must have negative results by a serum or urine pregnancy test performed within 7 days of day 1.\n* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n* Consolidation should occur between 1-4 weeks following count recovery after induction and remission (must be confirmed by labs to document maximal response) is established. Subjects will receive medium intensity cytarabine -based consolidation in combination with midostaurin and revumenib if the following criteria are fulfilled.\n\n  * an induction response \\\u003C 5% blasts in the bone marrow and ANC \\>1000 and PLT \\>75000 for whom documented path report is submitted.\n  * sufficiently fit (performance status \\\u003C3)\n  * resolution of any adverse reactions to no greater than grade 1 severity\n\nExclusion Criteria:\n\n* Subject has acute promyelocytic leukemia, inversion (16), t(8;21) AML as described below. Contact Sponsor-Investigator with questions. Inversion 16 and t(8;21): CBF chromosomal abnormalities may be assessed by molecular (PCR), metaphase cytogenetics, or FISH.\n* Subject has known active CNS involvement with AML.\n* Subject has received a strong CYP3A4 inducer (APPENDIX C) within 7 days prior to the initiation of study treatment\n* Strong CYP3A4 inhibitors (APPENDIX C) are contraindicated except strong CYP3A4 inhibitor antifungal azole medications (systemic itraconazole, ketoconazole, posaconazole, voriconazole). For strong CYP3A4 inhibitor antifungal azole medications, the starting dose of revumenib has to be adjusted (Table 1).\n* QTc using Fridericia's correction \\[QTcF\\]) \\> 450 msec. Drugs that prolong QTc should be avoided if possible. A list of common QTc prolonging drugs and alternatives that are not QTc prolonging can be found in APPENDIX D.\n* Subject has tested positive for HIV (due to potential drug-drug interaction between antiretroviral medications and Midostaurin\u002Frevumenib). Note: HIV testing is not required.\n* Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., HBs Ag-, and antiHBs+\\] are allowed.\n* Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to the initiation of study treatment.\n* Subject has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.\n* Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or any other medical condition that in the opinion of the investigator would adversely affect his\u002Fher participating in this study.\n* Subject has chronic respiratory disease that requires continuous oxygen use.\n* Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.\n* Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled systemic infection.\n* Subject has a history of other malignancies prior to study entry, with the exception of:\n\n  * Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;\n  * Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;\n  * Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n  * Prior malignancies treated with (surgery+\u002F- chemotherapy+\u002F- radiation) that have remained disease free for at least two years after completion of therapy\n* Subject treated with any form of chemotherapy, immunotherapy, or investigative agent within 1 month of enrollment.\n* Patients who have had prior exposure to a menin inhibitor.","18 Years",{"count":51,"type":23},22,[53],"PHASE1","This research is being conducted to determine a safe and effective dose of revumenib that can be given in combination with standard induction (initial therapy to induce a remission) + FLT3 targeted therapy (midostaurin) and a single cycle of post-remission therapy + FLT3 targeted therapy (midostaurin) to participants with newly diagnosed Nucleophosmin (NPM1) and FMS-like tyrosine kinase 3 (FLT3) mutated Acute Myeloid Leukemia (AML).\n\nThe names of the study drugs involved in this study are:\n\n* Revumenib (SNDX-5613) (a type of menin inhibitor)\n* Midostaurin (a type of multi-kinase including FLT3 inhibitor)\n* Cytarabine (a type of antineoplastic agent)\n* Daunorubicin (a type of antineoplastic agent)",[56,29,57,58,59],"Acute Myeloid Leukemia","AML With Gene Mutations","AML","Leukemia",[56,29,61,58,59],"AML with Gene Mutations","RECRUITING","2026-03-23",{"date":33,"type":34},{"date":66,"type":34},"2024-12-06",{"date":68,"type":23},"2028-03-02",{"name":70,"class":41},"Richard Stone, MD",2,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":79,"maxAge":20,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100603143","phase-3-comparison-of-va-and-dia-induction-regimens-in-elderly-fit-acute-myeloid-leukemia-patients-100603143","NCT07132684","Comparison of VA and D\u002FIA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients","A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D\u002FIA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy","Inclusion Criteria:\n\n* Diagnosis of AML according to WHO (2022) or ICC criteria.\n* Age ≥55 and ≤75 years.\n* ECOG performance status score of 0-2.\n* Adequate organ function:\n\n  * Total bilirubin ≤1.5× upper limit of normal (ULN)\n  * AST and ALT ≤2.5× ULN\n  * Serum creatinine \\\u003C2× ULN\n  * Cardiac enzymes \\\u003C2× ULN\n  * Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA fusion gene.\n* AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.\n* AML with BCR-ABL fusion gene.\n* Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).\n* Concurrent other malignancies requiring treatment.\n* Active cardiac disease (e.g., uncontrolled angina, recent myocardial infarction, severe arrhythmias, uncontrolled heart failure, LVEF below normal).\n* Severe infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).\n* Other conditions deemed unsuitable by the investigator.","55 Years",{"count":81,"type":23},240,[26],"This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D\u002FIA (Daunorubicin\u002FIdarubicin + Cytarabine)-in elderly patients (aged 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.",[29],[86,87,88],"acute myeloid leukemia","Older fit patients","venetoclax","2026-02-26",{"date":91,"type":34},"2026-03-02",{"date":93,"type":34},"2025-08-31",{"date":95,"type":23},"2028-08-30",{"name":40,"class":41},1,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":24,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":97},"100618174","quality-of-life-guided-transfusion-in-refractory-mds-or-aml-100618174","NCT07328191","Quality of Life-Guided Transfusion in Refractory MDS or AML","Quality of Life-based Transfusion in Refractory MDS or AML Under Advanced Palliative Care and Supportive Treatment.","Q-TRANS","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Diagnosis of refractory MDS or AML, receiving palliative care only.\n* Anaemia with haemoglobin ≤ 8 g\u002Fdl at inclusion (or ≤ 9 g\u002Fdl if associated with cardiovascular disease).\n* Transfusion dependency, defined as requiring more than 2 GR transfusions every 8 weeks.\n* No vitamin B9, vitamin B12 or iron deficiency.\n* Ability to understand and sign the informed consent form.\n* Ability to comply with the schedule of visits and other protocol requirements.\n\nNon inclusion Criteria:\n\n* Previous malignant disease other than MDS or AML (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast).\n* Active uncontrolled infection (hepatitis B or C, HIV).\n* Use of G-CSF.\n* Confirmed neurocognitive disorders (based on prior diagnosis or clinical assessment by the investigator) impairing comprehension, consent or the ability to reliably complete the EQ-5D-5L questionnaire.\n* Active uncontrolled heart disease.\n* Active haemolytic anaemia.\n* Recent major surgery.\n* Life-threatening complications of MDS\u002FAML.\n* Presence of another serious or unstable disease which, in the investigators' opinion, would make participation in the study inappropriate or risky for the patient's safety.\n* Vulnerable individuals.\n\nExclusion Criteria:\n\n* Immediate severe complications related to MDS\u002FAML, such as uncontrolled bleeding, pneumonia with hypoxia or shock, or severe disseminated intravascular coagulopathy.\n* Withdrawal of the patient's voluntary informed consent.",{"count":107,"type":23},52,[109],"NA","Patients with refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) in exclusive palliative care frequently receive red blood cell transfusions based on hemoglobin thresholds, despite limited evidence of clinical benefit in this setting.\n\nThis prospective randomized study compares a standard hemoglobin-based transfusion strategy to a quality-of-life-guided strategy using the EQ-5D-5L questionnaire, with the aim of reducing transfusion burden while maintaining patient safety and quality of life.",[112,29,113],"MDS","Anemia",[115,116,117,112,58],"palliative care","Chronic Transfusion-Dependent Anemia","Transfusion-dependent anemia","2026-02-10",{"date":120,"type":34},"2026-02-12",{"date":122,"type":34},"2026-02-09",{"date":124,"type":23},"2028-02-09",{"name":126,"class":41},"Centre Hospitalier Universitaire de Nice",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":133,"targetDuration":135,"studyType":136,"phases":4,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100545106","observatory-of-compassionate-use-of-ivosidenib-in-france-for-patients-with-acute-myeloid-leukemia-100545106","NCT06377579","OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patient with IDH1 R132 mutated with newly diagnosed or Relapsed or Refractory (R\u002FR) acute myeloid leukemia\n* Patient treated within French compassionate access program that have started the treatment between 01\u002F01\u002F2017 to 01\u002F08\u002F2023\n* patient treated by Ivosidenib received either as a monotherapy or in combination with other AML therapy (i.e. azacytidine, venetoclax)\n* Patient not included within IDH inhibitor clinical trial.\n\nExclusion Criteria:\n\n* Patients who expressed their opposition to entered in the study\n* Patients who received IVO through a trial",{"count":134,"type":23},250,"6 Months","OBSERVATIONAL","Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)\u002FαKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis\n\nIvosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R\u002FR) AML and in front line settings. In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R\u002FR settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R\u002FR. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R\u002FR patients and March 2022 for first line treatment.\n\nIn this multicentric retrospective study, sponsor aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R\u002FR disease. Results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R\u002FR IDH1mut AML.",[29],"2025-11-25",{"date":141,"type":34},"2025-11-26",{"date":143,"type":34},"2024-07-31",{"date":145,"type":23},"2026-06-01",{"name":147,"class":41},"French Innovative Leukemia Organisation",21,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":24,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":171},"100557103","phase-1-eganelisib-as-monotherapy-and-in-combination-with-cytarabine-in-relapsedrefractory-aml-100557103","NCT06533761","Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed\u002FRefractory AML","A Phase 1b Open-Label Study to Evaluate the Safety and Tolerability of Eganelisib as Monotherapy and in Combination With Cytarabine in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Pathological diagnosis of either: AML according to World Health Organization (WHO) 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts (acute promyelocytic leukemia is excluded but secondary AML and treatment-related AML can be included); Higher-risk (IPSS-R Intermediate, High or Very High Risk at time of study entry) myelodysplastic syndromes (HR-MDS) according to WHO 2022 revised criteria per the local pathology report and with ≥10% bone marrow blasts.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n* Adequate hepatic and renal function measured within 7 days prior to the first dose of eganelisib.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant within 6 months prior to Cycle 1 Day 1.\n* Receiving immunosuppressants (eg, cyclosporin) or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency).\n* Active fungal disease or uncontrolled infection of any kind; patients receiving antibiotic, antifungal or antiviral treatment must be afebrile and hemodynamically stable for \\>72 hours prior to treatment\n* WBC count \\>25 × 10\\^9\u002FL measured within 7 days prior to the first dose of eganelisib (hydroxyurea is permitted to decrease the WBC count).\n* Presence of a clinically significant non-hematologic toxicity of prior therapy that has not resolved to Grade ≤1 or Baseline, whichever is worst, as determined by NCI CTCAE v 5.0, except alopecia or skin pigmentation. Fatigue and neuropathy must have resolved to Grade ≤2.",{"count":157,"type":23},125,[53],"This is a Phase 1b open-label, multicenter, dose-escalation and dose-optimization study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of eganelisib as monotherapy and in combination with cytarabine in patients with relapsed\u002Frefractory (r\u002Fr) acute myeloid leukemia (AML) or r\u002Fr higher-risk myelodysplastic syndromes (HR-MDS).\n\nThe study consists of 2 parts:\n\n* Part 1: Dose Escalation (DE) in both monotherapy and in combination.\n* Part 2: Dose Optimization",[29,112],"2025-10-20",{"date":163,"type":34},"2025-10-22",{"date":165,"type":34},"2025-04-28",{"date":167,"type":23},"2028-03-15",{"name":169,"class":170},"Stelexis BioSciences","INDUSTRY",13,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":24,"phases":181,"briefSummary":182,"conditions":183,"keywords":184,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":97},"100603018","mrd-positive-aml-clinical-study-100603018","NCT07131059","MRD-positive AML Clinical Study","MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study","Inclusion Criteria:\n\n* AML (non-M3) compliant with WHO (2016) standards;\n* In morphological complete remission.\n* Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.\n* Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n* Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks\n* The diagnosis is APL\n* Those who were not considered suitable for inclusion by the researchers.",{"count":180,"type":23},120,[109],"This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.",[29],[185],"Measurable Residual Disease","2025-08-18",{"date":188,"type":34},"2025-08-20",{"date":190,"type":34},"2024-05-11",{"date":192,"type":23},"2028-04-30",{"name":40,"class":41},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":71},"100555529","observational-study-on-the-outcome-of-aml-patients-treated-with-new-drugs-in-real-life-boxtrial-100555529","NCT06513273","Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)","Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life","Box","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. AML diagnosis according to the ELN guidelines, excluding M3\n3. Signed Informed consent, if applicable\n4. Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:\n\n   * patients affected by FLT3-mutated AML treated with gilteritinib.\n   * patients affected by IDH-mutated AML treated with IDH inhibitors.\n   * patients affected by AML in maintenance therapy with oral azacytidine.\n   * patients affected by AML treated with glasdegib.\n   * patients affected by AML treated with gemtuzumab ozogamicin.\n   * other novel drugs or combination for the treatment of AML approved during the study period.\n\nExclusion Criteria:\n\nPatients included in interventional clinical trials.",{"count":203,"type":23},397,"This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.",[56,29,206],"Acute Myeloid Leukemia, Adult","2025-08-08",{"date":209,"type":34},"2025-08-13",{"date":211,"type":34},"2025-07-11",{"date":213,"type":23},"2029-12",{"name":215,"class":41},"Gruppo Italiano Malattie EMatologiche dell'Adulto",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":18,"minAge":224,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":97},"100509136","assessment-of-geriatric-evaluations-impact-on-new-aml-guidance-100509136","NCT05909501","Assessment of Geriatric Evaluations Impact on New AML Guidance","AGE-ING (Assessment of Geriatric Evaluations Impact on New AML Guidance) Study","AGE-ING","Inclusion Criteria:\n\n* AML diagnosis by peripheral flow cytometry and\u002For bone marrow aspirate and biopsy\n* New diagnosis being considered for new line of treatment\n* Age ≥ 50 years.\n* Performance status 0,1, and 2\n\nExclusion Criteria:\n\n* Inability to understand or unable to sign a written informed consent\n* Unable to fill out questionnaires on their own and\u002For do not have someone to help complete them","50 Years",{"count":226,"type":23},100,"The goal of the study is to measure physiologic age (there is no current formal definition but is meant to imply that patients should be evaluated holistically rather than on age alone) at baseline in newly diagnosed AML patients over 50 years receiving either intensive or non-intensive treatment. This information will be used to evaluate toxicity, early mortality, remission rates and long term survival.",[29],"2025-08-06",{"date":231,"type":34},"2025-08-07",{"date":233,"type":34},"2023-10-25",{"date":235,"type":23},"2026-12-01",{"name":237,"class":41},"Abramson Cancer Center at Penn Medicine",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":245,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":97},"100601970","venetoclax-decitabine-in-untreated-elderlyunfit-aml-100601970","NCT07117422","Venetoclax-Decitabine in Untreated Elderly\u002FUnfit AML","Efficacy and Safety of Venetoclax Plus Decitabine in Elderly\u002FUnfit Patients With Newly Diagnosed AML: A Multicenter Single-Arm Study","Inclusion Criteria:\n\n1. Patients meeting the World Health Organization (WHO) 2022 diagnostic criteria for acute myeloid leukemia (AML), excluding:Acute promyelocytic leukemia (APL)\n\n   AML with recurrent genetic abnormalities, including:t(8;21)(RUNX1::RUNX1T1)\n\n   inv(16)(p13.1q22) or t(16;16)(p13.1q22)\u002FCBFβ::MYH11\n2. Patients classified as AML, not otherwise specified (NOS) per WHO criteria, excluding:Acute panmyelosis with myelofibrosis 、Myeloid sarcoma\n3. Age and fitness criteria:\n\n   -Group A: Age ≥65 years (unwilling to receive intensive chemotherapy)\n\n   Group B: Age \\>18 years and ineligible for standard-dose chemotherapy, defined by ≥1 of the following:ECOG performance status 2 or 3；History of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) ≤50% DLCO ≤65% or FEV1 ≤65%Creatinine clearance ≥30 mL\u002Fmin but ≤45 mL\u002Fmin (Cockcroft-Gault or 24-hour urine collection)、Any other condition deemed incompatible with standard chemotherapy (requires PI approval)\n4. No prior AML therapy, except:Hydroxyurea、Low-dose cytarabine (\\\u003C1.0 g\u002Fday)\n5. ECOG performance status ≤3\n6. Laboratory requirements (within 7 days prior to treatment):AST\u002FALT\u002FALP ≤3×ULN (≤5×ULN if due to leukemic involvement)、Total bilirubin ≤2×ULN、Cardiac enzymes \\\u003C2×ULN、Serum creatinine clearance ≥30 mL\u002Fmin (measured or calculated)\n7. Contraception requirements:Negative pregnancy test (within 72 hours before treatment) for women of childbearing potential；Agreement to use effective contraception during treatment and for 3 years after therapy\n8. Life expectancy ≥2 months\n9. Informed consent:Signed by patient, legal guardian, or immediate family member (if patient is unable to consent due to medical condition)\n\nExclusion Criteria:\n\n1. AML with BCR::ABL1 fusion or chronic myeloid leukemia (CML) in blast crisis.\n2. Previously treated AML patients (received prior induction chemotherapy, regardless of response).\n3. Secondary AML, including:Therapy-related AML (per WHO classification)、AML with prior history of myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN)\n4. Concurrent hematologic disorders (e.g., hemophilia, myelofibrosis, or other conditions deemed ineligible by the investigator). Exception: Patients with prior blood count abnormalities but confirmed non-MDS\u002FMPN by bone marrow examination may be included.\n5. Pregnant or lactating women.\n6. Hypersensitivity to any study drugs.\n7. Use of strong\u002Fmoderate CYP3A4 inducers within 3 days prior to treatment initiation.\n8. Active malignancy in other organs (requiring treatment).\n9. Clinically significant hepatic\u002Frenal dysfunction exceeding inclusion criteria limits.\n10. Active cardiac disease, defined as ≥1 of the following:Myocardial infarction within 6 months before enrollment；History of symptomatic arrhythmia requiring medication；Uncontrolled\u002Fsymptomatic congestive heart failure (NYHA Class \\>2)\n11. Active infections, including:Untreated tuberculosis or pulmonary aspergillosis\n\n    Known HIV, active hepatitis B (HBV), or hepatitis C (HCV)\n12. Central nervous system (CNS) leukemia at baseline.\n13. Medical history of:Epilepsy requiring medication、Dementia or psychiatric disorders impairing protocol compliance\n14. Conditions limiting oral drug absorption (e.g., malabsorption syndrome).\n15. Investigator's discretion for ineligibility.","65 Years",{"count":247,"type":23},39,[109],"Acute myeloid leukemia (AML) is a highly fatal malignancy in China, with particularly poor outcomes in elderly patients. Low-intensity regimens yield low remission rates, and median overall survival (OS) typically remains under 6-9 months. Venetoclax (VEN) combined with hypomethylating agents (azacitidine or decitabine（DEC）) has emerged as a first-line therapy for these patients, significantly improving response rates and survival. However, challenges persist, including suboptimal complete remission (CR) rates, low Measurable Residual Disease（MRD） negativity, and tolerability issues with prolonged use.\n\nRecent studies suggest that a 3-day decitabine regimen combined with VEN may enhance efficacy and tolerability. Building on prior evidence and our institutional experience, we propose this study to evaluate an optimized dosing strategy of VEN plus decitabine in treatment-naïve elderly or chemotherapy-ineligible AML patients, aiming to further improve clinical outcomes.",[29],"2025-08-05",{"date":253,"type":34},"2025-08-12",{"date":255,"type":34},"2025-01-17",{"date":257,"type":23},"2027-01-30",{"name":259,"class":41},"The Second Hospital of Hebei Medical University",{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":271,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":71},"100526764","phase-2-pharmacoscopy-guided-clinical-standard-of-care-in-rr-aml-100526764","NCT06138990","Pharmacoscopy-guided Clinical Standard-of-care in r\u002Fr AML","Pharmacoscopy-guided Clinical Standard-of-care in Relapsed\u002FRefractory Acute Myeloid Leukemia, a Randomized Phase-2 Clinical Trial","RAPID-01","Inclusion criteria\n\n* Patient with refractory or relapsed AML according to ELN2022 criteria.\n* Age 18-70 years.\n* Considered to be eligible for intensive chemotherapy.\n* Written informed consent.\n\nExclusion criteria\n\n* Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes\u002Fchromosome translocations.\n* Blast crisis after chronic myeloid leukemia (CML).\n* Considered not eligible for intensive chemotherapy.\n* Condition of the patient does not allow to wait for PCY results (patient requires immediate treatment).\n* PCY not working \u002F patient sample did not pass the QC steps of PCY.\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the principal investigator may interfere with the project or affect patient compliance.\n* Legal incompetence or Subjects lacking capacity to provide informed consent.\n* Participation in a clinical trial with an investigational drug within the 30 days preceding and during the present investigation.","70 Years",{"count":270,"type":23},88,[272],"PHASE2","With an overall survival of below 12 months, the outcome of relapsed\u002Frefractory AML (RR AML) is poor, making it a critical challenge to identify effective therapies at this stage. The RAPID-01 trial aims to show for the first time in a randomized and controlled clinical trial that Pharmacoscopy (PCY), a functional precision medicine platform, helps improve clinical standard-of-care treatment selection for patients suffering from relapsed\u002Frefractory AML.",[29],[276,277,278],"relapsed \u002F refractory AML","Pharmacoscopy","Functional precision medicine","2025-05-13",{"date":281,"type":34},"2025-05-16",{"date":283,"type":34},"2024-09-02",{"date":285,"type":23},"2026-06-30",{"name":287,"class":41},"ETH Zurich",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":294,"maxAge":4,"enrollmentInfo":295,"targetDuration":297,"studyType":136,"phases":4,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100584576","epidemiological-study-of-a-prospective-cohort-of-patients-aged-60-and-over-managed-for-acute-myeloid-leukemia-aml-and-receiving-intensive-induction-therapy-100584576","NCT06891144","Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy","Inclusion Criteria:\n\n* Patients aged 60 and over\n* Patients with previously untreated de novo or secondary AML\n* Patients suitable for standard intensive treatment\n* Patients who have read the information document and agreed to the collection of data concerning them (signature of informed consent).\n\nExclusion Criteria:\n\n* Patients with AML 3\n* Patients with severe, uncontrolled infection at the time of inclusion\n* Patients with psychiatric or social disorders that will prevent compliance with the protocol\n* Patients without health insurance (affiliation to a social security scheme)","60 Years",{"count":296,"type":23},1000,"5 Years","This observational epidemiological study targets patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive receive intensive induction therapy as defined by the group. The main aim of the study is to determine the epidemiological characteristics of AML patients, both clinically and biologically, and to correlate these to their outcome. The incidence of AML increases with age, exponentially after the age of 50, giving a median age at diagnosis of close to 70 years, with over half of patients half of patients are over 60 at diagnosis. The principle of treatment as in younger patients, is based on trying to achieve complete remission (CR). remission (CR). Observed complete remission rates range from 38 to 70%. Long-term survival of elderly subjects remains limited, at around 10 to 15%, despite the various types of consolidation tried out in recent years.\n\nyears. However, intensive chemotherapy remains the preferred option for initial treatment of these hematological diseases when general condition and comorbidities allow. As shown by Swedish registry studies, it is associated with improved life expectancy.\n\nThe proportion of patients who can receive intensive initial treatment is not well known in France, probably varies widely from one region to another, and certainly decreases with increasing age. Only the registry studies currently underway will enable us to assess this precisely.",[29],"2025-03-20",{"date":302,"type":34},"2025-03-24",{"date":304,"type":34},"2015-01-06",{"date":306,"type":23},"2031-01-06",{"name":147,"class":41},27,{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":24,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},"100517781","phase-2-study-investigating-the-efficacy-and-safety-of-the-addition-of-oral-azacitidine-to-salvage-treatment-by-gilteritinib-in-subjects-18-years-of-age-with-relapsedrefractory-flt3-mutated-acute-myeloid-leukemia-100517781","NCT06022003","Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed\u002FRefractory FLT3-mutated Acute Myeloid Leukemia","Open-label, Phase 2 Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed\u002FRefractory FLT3-mutated Acute Myeloid Leukemia","OGILAR","Inclusion Criteria:\n\n1. Confirmed diagnosis of acute myeloid leukemia (AML) according to world health organization (WHO) 2016 classification\n2. Presence of FLT3-mutation(s) at inclusion: in case of FLT3-ITD, the ITD\u002Fwt ratio must be \\> 0.05 ; in case of FLT3-TKD, the mutation must be at D835 or I836 position with a VAF \\> 5% by NGS.\n3. Subjects must be primary refractory or relapsed (R\u002FR) to 1st line intensive chemotherapy (ICT) for AML. Hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis.\n\n3a. Primary refractory is defined as no CR or CRi after at least one course of ICT (including \"7+3\", gemtuzumab ozogamycin (GO)-based and CPX-351, including or not midostaurine) or two courses (maximum 4) of AZA and venetoclax 3b. Relapse after 1st line ICT for AML is defined as the first hematologic relapse with bone marrow blasts \\>5% after one line of treatment for AML that includes at least one course of ICT (one line of treatment for AML can include induction, re-induction, consolidation, allogeneic HSCT and maintenance) 3c. Relapse after 1st line non intensive chemotherapy for AML is defined as the first hematologic relapse with bone marrow blasts \\>5% after or during treatment by AZA venetoclax regardless of number of cycles 4. 1st line intensive treatment may or may not include previous treatment by tyrosine kinase inhibitor (TKI) except gilteritinib.\n\n5\\. Patients who never received oral azacitidine 6. Age ≥ 18 years 7. Adequate baseline organ function defined by the criteria below:\n\n* adequate renal function as demonstrated by a creatinine clearance ≥ 50 ml\u002Fmin; calculated by the Cockcroft gault formula or measured by 24-hours urine collection\n* aspartate aminotransferase (AST) ≤ 2.5 × ULN\n* alanine aminotransferase (ALT) ≤ 2.5× ULN\n* bilirubin ≤ 1.5 × ULN\n* adequate cardiac function with LVEF ≥45% 8. ECOG \\\u003C 3 (appendix 1) 9. Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule 10. Patient is suitable for oral administration of study drug. 11. A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies: 9a. Not a woman of childbearing potential (WOCBP) as defined in post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented as surgically sterile (at least 1 month prior to Screening) 9b. WOCBP agrees to follow the contraceptive treatment starting at screening and continue throughout the study period, and for at least 180 days after the final study drug administration 12. Patient must be affiliated to the french social security (health insurance) 13. Signed written informed consent for the study 14. Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 60 days after the final study drug administration.\n\n  15\\. Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.\n\n  16\\. A male subject with female partner(s) of childbearing potential must agree to use contraception starting at screening and continue throughout the study period, for at least 120 days after the final study drug administration.\n\n  17\\. Male subject must not donate sperm starting at screening and throughout the study period and for 120 days after the final study drug administration.\n\nExclusion criteria\n\n1\\. Subjects with any of the following current or previous diagnoses:\n\n1a. AML secondary to prior myeloproliferative syndrome (MPN)\n\n1b. Acute promyelocytic leukemia (APL) and core binding factor (CBF) AML\n\n1c. DNA fragility or bone marrow (BM) failure syndromes\n\n1d. Blastic plasmacytoid dendritic cell neoplasm\n\n1e. Acute lymphoblastic leukemia including ambiguous lineage 2. Patients ≥ 3rd line of treatment, HSCT being not considered as a line of treatment 3. Patients previously treated by AZA as single agent for AML are not allowed 4. Subjects that have previously been treated by gilteritinib 5. Subjects that have previously been treated by oral azacitidine 6. Clinically active central nervous system (CNS) leukemia 7. Subjects who have received more than 1 prior allogeneic HSCT 8. Subjects who have relapsed within 100 days after allogeneic HSCT 9. Presence of Grade 2 or above graft-versus-host disease (GVHD), including acute, chronic, or overlap; or escalation of therapy for GVHD within 14 days prior to randomization 10. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A (Annexe 7) 11. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-gp with the exception of drugs that are considered absolutely essential for the care of the subject (Annexe 7) 12. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis or hyperbilirubinemia) 13. Participant has clinically significant abnormality of coagulation profile, such as disseminated intravascular coagulation (DIC).\n\n14\\. Subject exhibiting evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).\n\n15\\. Isolated extramedullary leukemia relapse 16. History of another malignancy within the past 3 years except basal cell carcinoma of the skin or cervix in situ carcinoma 17. Any other serious medical condition, laboratory abnormalities or psychiatric illness that would place the participant at an unacceptable risk or prevent them from giving informed consent 18. Severe medical or mental condition precluding the administration of protocol treatments 19. persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care 20. Other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy which must be reviewed and approved by the study medical monitor before study enrolment 21. Subject with Positive HIV test (due to potential drug-drug interactions). HIV testing will be performed at screening, if required per local guidelines or institutional standards. Subject known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status with undetectable PCR viral load on antivirals (non-exclusionary medications) are not excluded 22. Known hypersensitivity to the study medication 23. Subject has congestive heart failure classified as New York Heart Association Class III and IV unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ≥ 45% 24. Subject with mean Fridericia-corrected QT interval (QTcF) \\> 450 ms at screening based on central reading 25. Subject with a history of Long QT Syndrome at screening",{"count":318,"type":23},33,[272],"Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group.\n\nUntil now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment.\n\nIn phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg\u002Fday before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R\u002FR patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials.\n\nThe aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed\u002Frefractory FLT3-mutated acute myeloid leukemia",[29,322,323,324,325],"Refractory AML","Relapsed Adult AML","FLT3-TKD Mutation","FLT3-ITD",{"date":302,"type":34},{"date":328,"type":34},"2024-01-13",{"date":330,"type":23},"2027-10",{"name":147,"class":41},20,{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":24,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":97},"100512045","phase-1-a-study-to-evaluate-the-sti-8591-in-subjects-with-advanced-acute-myeloid-leukemia-aml-100512045","NCT05947344","A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)","A Multicenter, Open, Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\nTo be enrolled in this study, subjects must meet all of the following inclusion criteria.\n\n1. Voluntary signing of ICF.\n2. Age ≥ 18 years old.\n3. Expected survival \\>12 weeks.\n4. Dose escalation component: Advanced primary AML or myelodysplastic neoplasm (MDS) secondary to AML or MDS\u002Fmyeloproliferative neoplasm (MPN)-associated AML (AML-MR) diagnosed by 2022 WHO AML typing and with diagnostic criteria that have failed standard therapy or are intolerant of standard therapy may be considered for inclusion in this component of the study. Dose extension section: Advanced primary AML or MDS secondary to AML or AML-MR diagnosed according to the 2022 WHO AML typing and associated diagnostic criteria, who have failed or are intolerant to standard therapy, or who are unable to access standard therapy for various reasons, may only be considered for inclusion in this part of the study.\n5. ECOG scores physical fitness status 0 to 2.\n6. Subjects are willing to undergo a bone marrow aspiration\u002Fbiopsy as required by the protocol, which is used to assess the subject's response to treatment.\n7. Laboratory test index requirements within 7 days prior to the first dose, including:\n\n   White blood cell count (WBC) ≤ 20 x 109 \u002FL \\[(hydroxyurea is allowed up to the first dose to stabilize the WBC count up to a maximum dose of 5 g\u002Fday. Hydroxyurea may be continued for up to 28 days after the first dose (i.e., the first dosing cycle) at the discretion of the investigator, but generally not beyond 28 days)\\].\n\n   Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver involvement is known).\n\n   Aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if liver involvement is known) Total bilirubin (TBIL) ≤ 1.5 x ULN (\\\u003C 3.0 x ULN if diagnosed with Gilbert's syndrome) Estimated glomerular filtration rate (eGFR, calculated according to the Cockcroft-Gault formula or by measuring 24-hour urine) \\> 50 mL\u002Fmin.\n8. Residual toxicity of previous antitumor therapy ≤ grade 1 (except alopecia and hyperpigmentation; see inclusion criteria 7 for laboratory test indices)\n9. Be willing and able to comply with the study schedule and all other study protocol requirements.\n10. Women of childbearing potential (WOCBP) (women of childless potential defined as sexually mature women who have undergone hysterectomy or bilateral oophorectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation\u002Fclosure, or who are unable to have children because of congenital or acquired disease or who have been spontaneously menopausal for ≥12 months) must have a negative blood pregnancy test performed during screening.\n11. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use a highly effective method of contraception from the time of screening until 180 days after the last treatment.\n12. Subjects are required to provide FLT3 mutation status testing within 6 months prior to the first dose, and if not, are willing to undergo screening period testing as required by the protocol.\n\nExclusion Criteria:\n\nTo be enrolled in this study, subjects must not meet any of the following exclusion criteria.\n\n1. Known hypersensitivity to any component of the study drug formulation.\n2. Subjects were diagnosed with acute promyelocytic leukemia (APL).\n3. Subjects have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).\n4. Subjects developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS\u002FMPN).\n5. Subjects had CNS leukemia with associated clinical symptoms.\n6. Enrolled in any therapeutic clinical study within 28 days prior to the first dose and enrolled in treatment, except in the survival follow-up phase of the interventional study.\n7. Received anti-tumor therapy (including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, etc.) within 28 days or 5 half-lives (whichever is shorter) prior to the first dose. Received radiotherapy within 14 days prior to the first dose. Palliative radiotherapy for symptom control is allowed to be completed at least 7 days prior to the first dose. Have received herbal therapy with approved indications for antitumor use within 7 days prior to the first dose.\n8. ≥ Grade 2 graft-versus-host disease (GvHD), including acute, chronic or overlapping or escalating GvHD therapy within 14 days prior to first dose or being treated with systemic cortisol hormone for GvHD.\n9. Received chimeric antigen receptor T-cell immunotherapy (CAR-T) within 3 months prior to the first dose.\n10. Strong inducer or strong inhibitor of cytochrome P450 (CYP450) 2C8 or 3A4 enzymes taken within 14 days prior to the first dose, unless the investigator assesses that the drug is necessary for the subject's treatment regimen.\n11. Major surgery within 28 days prior to first dose or minor surgery within 7 days prior to first dose, except diagnostic biopsy, insertion of vascular access device\n12. Subjects have clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and vascular hemophilia.\n13. Intractable hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and with previous recurrent episodes.\n14. Active tuberculosis, or interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, history of radiation pneumonia, or clinically active interstitial lung disease as suggested by any current evidence, prior to the first dose.\n15. Presence of an uncontrolled active infection (defined as exhibiting persistent signs\u002Fsymptoms associated with the infection that do not improve despite appropriate antibiotic or other treatment) within 72 hours prior to the first dose. Ongoing use of prophylactic antibiotics, antifungals, or antivirals is eligible for enrollment.\n16. Inability to take oral medication, history of previous surgery or severe gastrointestinal disorders such as dysphagia and active gastric ulcer, which the investigator believes may affect the absorption of the study drug.\n17. History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (other than thrombosis due to vascular access devices or superficial venous thrombosis) within 3 months prior to the first dose.\n18. Active or uncontrolled HBV (HBsAg positive and\u002For HBcAb positive with positive HBV-DNA titers), HCV (HCV-Ab positive with positive HCV-RNA titers), HIV positive.\n19. History of clinically significant cardiovascular disease, including.\n\n    1. Congestive heart failure (NYHA classification ≥ Class III) within 6 months prior to first dose\n    2. Unstable angina occurred within 6 months prior to the first dose.\n    3. Myocardial infarction within 6 months prior to the first dose.\n    4. Presence of poorly controlled arrhythmias at screening (e.g., subjects with ventricular tachycardia occurring during antiarrhythmic drug therapy will be excluded; however, subjects with atrioventricular block of degree I or asymptomatic left anterior bundle branch block\u002Fright bundle branch block do not have to be excluded).\n    5. Diagnosis or suspicion of long QT syndrome at screening (including a family history of long QT syndrome)\n    6. QTcF interval \\>450 msec (using the Fridericia formula).\n    7. Left ventricular ejection fraction (LVEF) \\\u003C45%.\n    8. Uncontrolled hypertension (on the basis of lifestyle improvement, blood pressure has not reached the standard after applying a reasonably tolerable adequate dose of 2 or more antihypertensive drugs for more than 1 month, or blood pressure can be effectively controlled only after taking 4 or more antihypertensive drugs).\n    9. Stroke, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose.\n20. Pregnant or lactating women.\n21. Any active serious mental illness, medical condition or other symptom\u002Fcondition that, in the judgment of the investigator, may interfere with treatment, compliance or the ability to provide informed consent.",{"count":341,"type":23},84,[53],"This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study.\n\n* Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591.\n* Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.",[29],[346],"FLT3 inhibitor","2025-03-12",{"date":349,"type":34},"2025-03-17",{"date":351,"type":34},"2023-12-08",{"date":353,"type":23},"2025-12",{"name":355,"class":170},"Zhejiang ACEA Pharmaceutical Co. Ltd.",{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":294,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":365,"briefSummary":366,"conditions":367,"keywords":368,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":97},"100580795","study-of-tretinoin-capsules-in-combination-with-azacitidine-and-venetoclax-in-treatment-nave-participants-with-acute-myeloid-leukemia-100580795","NCT06841952","Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia","A Prospective, Two-arm, Multi-center Clinical Study of the Efficacy and Safety of Tretinoin Capsules Combined With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Patients initially diagnosed with AML (excluding APL) according to WHO diagnostic criteria.\n* Patients who have not previously received other induction therapies (excluding hydroxyurea and leukapheresis).\n* Total white blood cell (WBC) count ≤ 25 × 10\\^9\u002FL.\n* Ages 18 to 60 years, inclusive, with no gender restrictions.\n* ECOG Performance Status score of 0-2.\n* Total bilirubin ≤ 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Aspartate aminotransferase (AST) ≤ 3 times ULN; (excluding leukemia infiltration).\n* Endogenous creatinine clearance rate ≥ 30 ml\u002Fmin.\n* Enrolled patients must be capable of understanding and willing to participate in the study, and must sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with Acute Promyelocytic Leukemia (APL).\n* Patients with concomitant central nervous system leukemia or extramedullary leukemia involvement, such as testicular infiltration.\n* Patients with current or historical immunodeficiency virus infection.\n* Patients with active Hepatitis B or Hepatitis C infection.\n* Patients with a history of drug allergy, including but not limited to etoposide, azacitidine, venetoclax, daunorubicin, and cytarabine.\n* Patients with active or progressive malignant tumors or severe infections.\n* Patients with a left ventricular ejection fraction (LVEF) of less than 30%, classified as New York Heart Association (NYHA) Class III or above, and those deemed ineligible for enrollment by the investigator.\n* Patients who are pregnant or breastfeeding.\n* Patients who refuse to participate in the study.",{"count":364,"type":23},158,[109],"This study was a prospective, two-arm, multicenter clinical trial to evaluate the efficacy and safety of tretinoin capsules combined with azacitidine and venetoclax in the treatment of newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax, and tretinoin may arrest cancer cell growth by demethylation, promoting cell differentiation, or killing cells, while reducing blood-related adverse effects by promoting cell differentiation.",[29],[369,370,88],"tretinoin","azacitidine","2025-02-18",{"date":373,"type":34},"2025-02-24",{"date":375,"type":23},"2025-02-15",{"date":377,"type":23},"2030-12-15",{"name":379,"class":41},"The First Affiliated Hospital of Soochow University",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":20,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":97},"100574949","phase-2-selinexor-combined-with-venetoclax-maintenance-therapy-after-allo-hsct-100574949","NCT06765928","Selinexor Combined With Venetoclax Maintenance Therapy After Allo-HSCT","A Multicenter, Single-arm Study of the Efficacy and Safety of Selinexor Combined With Venetoclax as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia\u002FMyelodysplastic Syndrome","Inclusion Criteria:\n\n* de novo AML in the ELN2022 high-risk group or MDS in the IPSS-M intermediate-high\u002Fhigh\u002Fvery-high risk group\n* Age 18-75 years old, gender is not limited\n* First hematopoietic stem cell transplant with at least one eligible donor\n* ECOG physical status score of 0-2\n* The subject has received an allogeneic hematopoietic stem cell transplant within 90-120 days and STR-PCR shows complete donor chimerism;\n* Have appropriate organ function, and laboratory results within 7 days prior to the start of trial treatment need to meet the following criteria:\n\nAST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g\u002FL (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\\^9\u002FL (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\\^9\u002FL (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;\n\n* Life expectancy ≥ 12 weeks;\n* Voluntarily sign the informed consent form and understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n* bone marrow examination after allo-HSCT suggestive of relapse or measurable residual disease (MRD) before the initiation of maintenance therapy;\n* Other malignant tumors within 5 years prior to screening, except adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancers, post-radical thyroid cancer, and post-radical ductal carcinoma in situ;\n* Current active cardiovascular disease of clinical significance, such as uncontrolled arrhythmias, uncontrolled hypertension, congestive heart failure, any grade 3 or 4 heart disease as determined by the New York Heart Association (NYHA) functional class, or a history of myocardial infarction within the 6 months prior to screening;\n* Other serious medical conditions that may limit the patient's participation in this trial (e.g., active infection, uncontrolled diabetes);\n* Known HIV infection, or chronic infection with hepatitis B virus (HBsAg-positive) or hepatitis C virus (anti-HCV-positive) that cannot be controlled by medications;\n* Patients with other tumors in combination, not cured;\n* Patients with neurologic or psychiatric disorders; clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome);\n* Those who are allergic to the test drug;\n* Those who are unable to understand or comply with the study protocol or are unable to sign the informed consent form;\n* Those who have received other maintenance drugs after hematopoietic stem cell transplantation or have the desire to receive other maintenance therapy;\n* Participation in other clinical studies within 3 months prior to screening that have not interfered with the safety and efficacy of the study drug as assessed by the investigator is permitted for inclusion in the study, e.g., non-interventional observational studies;\n* Patients who, in the investigator's judgment and\u002For clinical criteria, have contraindications to any of the study procedures or have other medical conditions that may place them at unacceptable risk.",{"count":388,"type":23},73,[272],"A multicenter, single-arm clinical study of evaluate the efficacy and safety of selinexor combined with venetoclax as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients.",[112,29],[393,394,395],"MDS\u002FAML","allogeneic hematopoietic stem cell transplantation","maintenance therapy","2025-01-05",{"date":398,"type":34},"2025-01-09",{"date":400,"type":23},"2025-01-01",{"date":402,"type":23},"2028-01-01",{"name":404,"class":41},"Ruijin Hospital",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":268,"enrollmentInfo":412,"targetDuration":4,"studyType":24,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":97},"100574948","phase-2-avapritinib-maintenance-for-aml-with-kit-mutations-100574948","NCT06765915","Avapritinib Maintenance for AML With KIT Mutations","Avapritinib Maintenance Following Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia With KIT Mutations","Inclusion Criteria:\n\n* Age≥ 14 years old;\n* First allo-HSCT for AML (including secondary AML) ;\n* KIT mutation at diagnosis (no restriction on locus for kit mutation\n* CR and negative MFC-MRD prior to initiation of maintenance therapy;\n* Absolute neutrophil count ≥ 1.0 x 109 \u002FL, platelets ≥ 75 x 109 \u002FL, hemoglobin ≥ 80 g\u002FL before maintenance;\n* Normal functioning of major organs and laboratory findings in accordance with the following criteria:AST and ALT) ≤ 3x ULN; Total serum bilirubin ≤ 1.5x ULN unless the patient has Gilbert syndrome; patients with Gilbert-Meulengracht syndrome with bilirubin ≤ 3.0 times the upper limit of normal and direct bilirubin ≤ 1.5 times the upper limit of normal may be included; HB ≥ 70 g\u002FL (had not received a red blood cell transfusion within 1 week prior to administration); ANC ≥ 0.8 x 10\\^9\u002FL (had not received long-acting colony-stimulating factor (LACSF) within 1 week prior to administration and short-acting colony-stimulating factor (SACSF) within 3 days prior to administration); Platelet count ≥ 20 x 10\\^9\u002FL (had not received a platelet transfusion within 1 week prior to administration); serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL\u002Fmin; Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥45%;\n* ECOG PS 0-2 points;\n* Expected survival ≥ 3 months;\n* Patient consent\n\nExclusion Criteria:\n\n* concurrently receiving other targeted therapies for AML;\n* Prior treatment with a TKI inhibitor that proved ineffective;\n* with concurrent FLT3-ITD mutations at enrollment;\n* Acute\u002Fchronic graft-versus-host disease requiring systemic immunosuppressive therapy prior to maintenance therapy;\n* Accompanied by other malignant tumors requiring treatment;\n* Have important organ-based diseases: e.g., myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal failure;\n* Active, uncontrolled infection;\n* HIV-positive, active hepatitis B (HBV) or active hepatitis C (HCV) requiring antiviral therapy;\n* Other interventional clinical studies have been enrolled;\n* Men and women of childbearing potential are unwilling to use contraception during and for 12 months after treatment;\n* The investigator believes that there are other conditions that make the patient unsuitable for participation in this study.",{"count":413,"type":23},47,[272],"A multicenter, single-arm clinical study of evaluate the efficacy and safety of avapritinib as maintenance therapy following allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia patients with KIT mutation.",[29],[58,418,419],"KIT mutation","avapritinib",{"date":398,"type":34},{"date":422,"type":23},"2025-02-01",{"date":424,"type":23},"2028-02-01",{"name":404,"class":41},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":18,"minAge":434,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":24,"phases":438,"briefSummary":439,"conditions":440,"keywords":442,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":97},"100548366","phase-1-sequential-car-t-cells-targeting-cd33cd123-in-patients-with-acute-myelocytic-leukemia-aml-100548366","NCT06420063","Sequential CAR-T Cells Targeting CD33\u002FCD123 in Patients With Acute Myelocytic Leukemia AML","Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory\u002FRelapsed Acute Myeloid Leukaemia","BAH244","Inclusion Criteria:\n\n* Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:\n* Age older than 6 months.\n* Confirmed expression of CLL-1, CD123 and\u002For CD33 in blast AML by immuno-histochemical staining or flow cytometry.\n* Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n* Hgb≥80g\u002FL.\n* No cell separation contraindications.\n* Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n* Active bacterial, fungal or viral infection not controlled by adequate treatment.\n* Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Pregnant or nursing women may not participate.\n* Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n* Patients, in the opinion of investigators, may not be able to comply with the study.","6 Years","90 Years",{"count":437,"type":23},85,[53,272],"This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.",[58,56,441,29],"AML, Adult Recurrent",[443,444,445,446],"aml","cd33","cd123","CAR-T","2024-11-10",{"date":449,"type":34},"2024-11-12",{"date":451,"type":34},"2024-07-10",{"date":453,"type":23},"2026-12-28",{"name":455,"class":41},"Essen Biotech",{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":464,"targetDuration":466,"studyType":136,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":477},"100536327","results-from-a-french-temporary-utilization-authorization-of-first-line-acute-myeloid-leukemia-aml-patients-ineligible-for-intensive-chemotherapy-ic-treated-with-venetoclax-azacitidine-100536327","NCT06263387","Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine","Results From a Nationwide Cohort Temporary Utilization Authorization (ATU) of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC),Treated in France With Venetoclax Azacitidine","VENAZA","Inclusion Criteria:\n\n* Adult patients\n* treatment with VEN-AZA for newly diagnosed AML and ineligible to intensive chemotherapy\n* Treatment in the named-patients program (ATU)\n\nExclusion Criteria:\n\n* Treatment with VEN-AZA for previously treated AML\n\n  * Prior treatment for preexisting hematological malignancies other that AML, including AZA is not an exclusion criteria\n  * HYDROXYCARBAMIDE given for AML is not an exclusion criteria\n  * AZA started before VEN for AML is not an exclusion criteria\n* Opposition to data collection",{"count":465,"type":23},230,"18 Months","Following the results of the phase 1b and the phase 3 studies, Venetoclax\u002FAzacitidine (VEN\u002FAZA) was available in France for newly diagnosed AML patients ineligible-IC patients through the early access program the so-called ATU program.\n\nVenetoclax (VEN) has been available in France through the ATU since Feb 2021 and through the current post-ATU schema from the point of marketing authorization approval and up to the pending publication of reimbursement and price. Between February 15, 2021, and June 30, 2021, 285 requests for ATU were made to the pharmaceutical company (Abbvie) and led to the initiation of treatment of more than 230 patients. At the end of ATU period, all these 230 ATU patients continued to be treated by VEN\u002FAZA as part of the current post-ATU period. Healthcare professionals and health care decision makers need real world data to better understand the benefit\u002Frisk profile of treatment. Early access to treatment in France is close to real-life setting condition.",[29],"2024-07-22",{"date":471,"type":34},"2024-07-23",{"date":473,"type":34},"2024-07-04",{"date":475,"type":23},"2025-03-30",{"name":147,"class":41},42,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":97},"100553458","il-6-a-marker-for-aml-chemo-sensitivity-100553458","NCT06486350","IL-6: A Marker for AML Chemo Sensitivity","Bone Marrow Supernatant IL-6 as a Predictor of Chemotherapy Sensitivity in AML Patients","Inclusion Criteria:\n\n1. Clinical diagnosis aligns with the \"Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)\";\n2. All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;\n3. Patients participate in the study accompanied by family members and sign informed consent documents.\n\nExclusion Criteria:\n\n1. Patients with concurrent malignancies requiring treatment;\n2. Presence of infectious diseases, including SARS, viral hepatitis, or HIV\u002FAIDS;\n3. Major surgery performed within the last 21 days;\n4. Performance Status (PS) score \\>3;\n5. Severe liver or kidney dysfunction or serious infection;\n6. Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.",{"count":486,"type":23},72,"Acute myeloid leukemia (AML) is a clonal malignancy that arises from the primitive hematopoietic cells within the hematopoietic system. According to SEER cancer statistics, the 5-year survival rate for AML patients stands at a concerning 30%. Despite therapeutic advancements, the development of chemotherapy resistance and the risk of disease relapse pose significant barriers to curative outcomes. Evidence has linked elevated interleukin-6 (IL-6) levels in plasma and bone marrow to a poorer prognosis in AML, with IL-6 potentially fostering chemotherapy resistance through the enhancement of fatty acid uptake and the induction of stromal-like morphological changes in AML cells. However, the role of IL-6 as a potential biomarker for monitoring chemotherapy sensitivity in AML has not been fully elucidated. This study seeks to investigate the correlation between IL-6 levels in bone marrow supernatant and the sensitivity to chemotherapy, offering a clinical perspective that could pave the way for improved prognostic markers and personalized treatment strategies.",[29],[58,490,491],"IL-6","Chemotherapy sensitivity","2024-06-30",{"date":494,"type":34},"2024-07-03",{"date":496,"type":34},"2023-10-01",{"date":498,"type":23},"2025-06",{"name":500,"class":41},"Fujian Medical University Union Hospital",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":508,"maxAge":245,"enrollmentInfo":509,"targetDuration":4,"studyType":24,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":97},"100538971","phase-3-compare-the-efficacy-and-safety-of-dec-fb4-and-fb4-as-conditioning-regimen-for-aml-mr-100538971","NCT06297772","Compare the Efficacy and Safety of Dec-FB4 and FB4 as Conditioning Regimen for AML-MR","Comparing the Efficacy and Safety of Decitabine-Fludarabine-busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as Conditioning Regimens for AML-MR","Inclusion Criteria:\n\n* Age 16-65 years and with an ECOG physical fitness score of 0-2 and an HCT-CI of less than 3;\n* Diagnosis: All enrolled cases were diagnosed with acute myeloid leukemia (AML-MR) after bone marrow cytomorphology, cytochemistry, immunophenotyping, chromosomal examination, and gene mutation, and achieved hematological remission (bone marrow smear primitive cells \\\u003C5%) and negative MRD before transplantation.\n* Have a medically qualified and suitable hematopoietic stem cell donor, including HLA-allogamous sibling donors, unrelated donors (HLA high-resolution 9-10\u002F10 compatible) or related haploidentical donors;\n* No dysfunction of the heart, liver, lungs, kidneys, or other important organs, as defined as follows: ALT and AST ≤3 times the upper limit of normal; total bilirubin ≤2 times the upper limit of normal); BUN and Cr ≤1.25 times the upper limit of normal; electrocardiograms not suggestive of acute myocardial infarction or serious arrhythmias; cardiac echocardiography left ventricular ejection fraction ≥50%, no significant cardiac enlargement, valvular disease, or congenital heart disease; pulmonary function examination FEV1, FVC, DLCO ≥ 60% of the predicted value.\n* The patient and his\u002Fher legal representative have the desire and requirement to undergo hematopoietic stem cell transplantation and sign an informed consent, willingness and compliance with the treatment plan, follow-up schedule, laboratory tests, etc.\n\nExclusion Criteria:\n\n* AML in unremitting stage; or BM in remission but with concurrent CNS leukemia or presence of extramedullary lesions;\n* Active hepatitis B (HBV-DNA ≥1×10\\^3 copies\u002Fml);\n* HIV-infected patients;\n* Active infections requiring intravenous antibiotic therapy;\n* There is severe impairment of vital organ function: respiratory failure, heart failure, decompensated hepatic insufficiency, renal insufficiency, etc;\n* Patients who use drugs or chronic alcohol abuse to the extent that it interferes with the evaluation of test results;\n* Mentally challenged\u002Funable to obtain informed consent;\n* Those judged by the investigator to be unsuitable for participation in this trial.","16 Years",{"count":510,"type":23},220,[26],"A multicenter, randomized, controlled clinical study comparing the efficacy and safety of allogeneic hematopoietic stem cell transplantation with decitabine-Fludarabine- busulfan (Dec-FB4) and Fludarabine-busulfan (FB4) as pretreatment regimens for the treatment of acute myeloid leukemia in adults with MR gene abnormalities",[29],[515,516,517],"AML-MR","adults","conditioning regimen","2024-06-02",{"date":520,"type":34},"2024-06-04",{"date":522,"type":23},"2024-06-01",{"date":524,"type":23},"2028-05-01",{"name":404,"class":41},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":24,"phases":535,"briefSummary":536,"conditions":537,"keywords":538,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":97},"100544345","phase-1-natural-killernk-cell-therapy-targeting-cll1-or-cd33-in-acute-myeloid-leukemia-100544345","NCT06367673","Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia","Clinical Study to Evaluate the Safety and Efficacy of iPSC -NK Cells Targeting CLL1 or CD33 in Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n* ≥18 years old.\n* Confirmed diagnosis of r\u002Fr AML\n* CLL1 or CD33 expression is positive in AML blasts.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.\n* Adequate organ and marrow function, as defined below:\n\n  1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL\u002Fmin;\n  2. Total bilirubin (TBIL) ≤ 2 x the ULN;\n  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;\n  4. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN 6.Females of childbearing potential must have a negative serum pregnancy test. 7.Donor specific antibody (DSA) is negative: MFI \\\u003C= 2000. 8.Provision of signed and dated informed consent form (ICF).\n\nExclusion Criteria:\n\n* Allergic to drug used in this study.\n* Subjects received any antitumor therapy as follows, prior to first NK infusion:\n\n  a. Systemic steroid therapy within 3 days (except physiological replacement therapy):b. Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less; c. Radiotherapy within 4 weeks; d. Donor lmphocyte infusion within 6 weeks: e. Intrathecal treatment within 1 week; f CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;\n* History of allogeneic stem cell transplantation.\n* Received the vaccine within 4 weeks pror to the first infusion andor expected to reuire vaccination from the study period to 12 weeks ater the last intusion\n* Active central nervous system Leukemia.\n* Acute Promyelocytic Leukemia (APL).\n\n  .History of other malicnant tumors, except for those who have achieved omplete remission more than 5 years after radical treatment without any sions of recurence9. History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc\n* Active autoimmune diseases.\n* Serious cardiovascular and cerebrovascular diseases:a. Severe heart rhythm or conduction abnormalities, corrected OT interval (OTc)\\>480 ms:h, Aute coronay sndrome conestve heat faur. aortic disection-stroke. or other orade 3 or hioher ardiovasular and cerebrovascular events within 6 months orior to firstinfusiorC, New York Heart Association (NYHA) class l or above congestive heart failure or left ventricular eiection fraction (LVEF \\\u003C50% in olor Doppler echocardiography,d. Hypertension that cannot be controlled by drug.\n* Active pulmonary infection: Sp02 90%: Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease\n* Uncontrolled bacterial, fungal, or viral infection.Known HlV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection\n* Historv of substance abuse.\n* Toxicity induced by previous therapy not recovered to s grade 2(NCI-CTCAE 5.0).15. Large suraical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.16. Pregnant\u002Fbreastfeeding women.17. nvestigator-assessed presence of any medical or social issue that are likely to interfere with study conduct or may cause increased risk to subiect",{"count":534,"type":23},24,[53],"This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed\u002Frefractory AML",[29],[58],"2024-04-16",{"date":541,"type":34},"2024-04-18",{"date":543,"type":23},"2024-04-30",{"date":545,"type":23},"2026-08-31",{"name":547,"class":41},"Zhejiang University",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":24,"phases":557,"briefSummary":558,"conditions":559,"keywords":561,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":4},"100523066","kinetics-and-impact-on-survival-of-mrd-in-aml-patients-receiving-azacitidine-and-venetoclax-100523066","NCT06090786","Kinetics and Impact on Survival of MRD in AML Patients Receiving Azacitidine and Venetoclax","A Multicentric, Prospective Study Addressing the Kinetics and Impact on Survival of Measurable Residual Disease in Acute Myeloid Leukemia Patients Receiving Azacitidine and Venetoclax","Inclusion Criteria:\n\n* Subject must be ≥ 18 years of age\n* Subject has diagnosis of AML according to WHO 2016\n* Subject has newly diagnosed, previously untreated, AML, including de novo, secondary and therapy-related (cytoreduction with hydroxyurea is admitted prior treatment start)\n* Subject is planned to receive front-line therapy with Azacitidine and Venetoclax\n* Subject is ineligible for intensive induction chemotherapy according to investigator assessment according to clinical practice\n* Subject must have assessable MRD by flow cytometry at screening BM evaluation\n* Signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n\nExclusion Criteria:\n\n* Diagnosis of BCR::ABL1-positive AML\n* Diagnosis of APL\n* AML with CNS involvement.\n* AML with extra-medullary localizations\n* Patients' unwillingness or inability to comply with the protocol requirements.",{"count":556,"type":23},225,[109],"The goal of this no-profit, multicenter, biological, non-pharmacologic study is to evaluate minimal residual disease (MRD) in patients treated with Azacitidine and Venetoclax according to clinical practice.\n\nThe main questions it aims to answer are:\n\n1. kinetics of disease response on treatment with Azacitidine and Venetoclax through the evaluation of MRD with both cytofluorimetric and molecular techniques\n2. impact of MRD on survival outcomes. To this end, bone marrow samples will be collected at pre-defined time-points during treatment and MRD will be assessed.",[29,560],"Minimal Residual Disease",[562,563,58,564],"Venetoclax","Azacitidine","Minimal rsidual disease","2024-04-09",{"date":567,"type":34},"2024-04-10",{"date":569,"type":23},"2024-07",{"date":571,"type":23},"2027-07",{"name":215,"class":41},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":24,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":590,"leadSponsor":592,"locationsCount":594},"100517203","phase-2-a-trial-to-assess-cobicistat-boosted-venetoclax-in-combination-with-azacitidine-in-adult-patients-with-newly-diagnosed-aml-100517203","NCT06014489","A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML","A Single Arm Phase II Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine (sc) in Adult Patients With Newly Diagnosed Acute Myeloid Leukaemia (AML) Who Are Not Considered Candidates for Intensive Treatment Regimens","HO171","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n* Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia) (appendix A). Patients may have had previous treatment with erythropoiesis stimulating agents (ESA) for an antecedent phase of MDS. ESAs must be stopped at least two weeks before registration.\n* Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.\n* WHO performance status 0, 1 or 2 (appendix E).\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n\n  * Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n  * Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert's syndrome.\n  * Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.\n* Male subjects who are sexually active, must agree, from Study Day 1 until at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male subjects must agree to refrain from sperm donation from initial study drug administration through at least 90 days after the last dose of study drug.\n* Female subjects must be either postmenopausal defined as: Age \\>55 years with no menses for ≥12 months, without an alternative medical cause. OR willing and able to use adequate contraception during and until 180 days after the last protocol treatment.\n* Written informed consent.\n* Patient is capable of giving informed consent.\n* Patient agrees not to participate in another interventional study while on treatment without approval of the (co-) Principal Investigator.\n\nExclusion Criteria:\n\nA patient who meets any of the following criteria cannot be included in this study:\n\n* Acute promyelocytic leukemia.\n* Myelodysplastic syndrome (MDS).\n* Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea (hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis).\n* Diagnosis of any previous or concomitant malignancy is an exclusion criterion:\n\n  * except when the patient successfully completed treatment (chemotherapy and\u002For surgery and\u002For radiotherapy) with curative intent for this malignancy at least 24 months prior to registration;\n  * except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.\n* Blast crisis of chronic myeloid leukemia.\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.).\n* Cardiac dysfunction as defined by:\n\n  * Myocardial infarction within the last 3 months of study entry, or\n  * Reduced left ventricular function with an ejection fraction \\\u003C 40% as measured by MUGA scan or echocardiogram, or\n  * Unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix G), or\n  * Unstable cardiac arrhythmias.\n* History of stroke or intracranial haemorrhage within 6 months prior to registration.\n* Symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement).\n* History of non-compliance to medical regimens or considered unreliable with respect to compliance.\n* Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Unreplaceable use of strong inhibitors or inducers of CYP3A or CYP3A\u002Fp-GP substrates with a narrow therapeutic window (e.g. cobicistat or ritonavir for HIV treatment). Please check with Appendix I.\n* Intolerability, contra-indication or allergy to one of the study drugs.",{"count":582,"type":23},142,[272],"The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.",[29],"2024-01-17",{"date":588,"type":34},"2024-01-18",{"date":586,"type":34},{"date":591,"type":23},"2028-03",{"name":593,"class":41},"Stichting Hemato-Oncologie voor Volwassenen Nederland",18,{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":49,"maxAge":268,"enrollmentInfo":602,"targetDuration":4,"studyType":136,"phases":4,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":612,"locationsCount":4},"100530546","d-index-as-a-predictor-of-complication-of-treatment-of-patients-with-acute-myeloid-leukemia-100530546","NCT06188182","D-index as a Predictor of Complication of Treatment of Patients With Acute Myeloid Leukemia","D-index as a Predictor of Complications of Febrile Neutropenia in Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Adult Patients (≥18 years) newly diagnosed as acute myeloid leukemia according to WHO 2016 diagnostic criteria.\n2. Hematologic diagnosis of de novo AML.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.\n4. Standard induction chemotherapy (7+3 regimen) or consolidation regimens (HiDAC).\n\nExclusion Criteria:\n\n1\\) AML on top of other hematological disorders. 2) Acute promyelocytic leukemia. 3) Patients who received palliative care or low-intensity treatment. 4) Poor PS (≥3) at the time of diagnosis.\n\n\\-",{"count":603,"type":23},60,"1. The effect of D-index on the onset and severity of FN in AML patients.\n2. Relationship between the c-D-index and duration of FN in AML patients.\n3. Correlation between D-index and MDR.\n4. Correlation between D-index and invasive fungal infection.\n5. Comparison of FN in different treatment protocols for AML using D-index.\n6. Prediction of pulmonary, fungal or blood stream infection.",[29],"2024-01-01",{"date":608,"type":34},"2024-01-03",{"date":522,"type":23},{"date":611,"type":23},"2026-06",{"name":613,"class":41},"Assiut University"]