[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-adult":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,65,94,121,146,169,195,223,251],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100366362","phase-2-clag-go-for-patients-with-persistent-relapsed-or-refractory-aml-100366362",false,"NCT04050280","CLAG-GO for Patients With Persistent, Relapsed or Refractory AML","A Phase II Study of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for the Treatment of Patients With Persistent, Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Adult patients age 18 years or older, with a pathologically confirmed diagnosis of AML \\[excluding acute promyelocytic leukemia (APL)\\] according to WHO criteria. AML may be de novo, or following a prior hematologic disease and\u002For therapy-related.\n2. Patients must have relapsed after or be refractory to at least one course of an intensive chemotherapy regimen, for example anthracycline\u002Fcytarabine (\"7+3\" or daunorubicin and cytarabine liposome). Patients with residual disease on day 13-22 of initial induction chemotherapy are eligible, provided the bone marrow cellularity is ≥ 30% AND bone marrow blasts are ≥ 20%. Hypomethylating agents such as azacitidine or decitabine are allowed as a prior therapy, but are not considered an intensive chemotherapy regimen.\n3. Eastern Cooperative Oncology Group performance status of 0-2.\n4. Any systemic chemotherapy and any radiotherapy must be completed at least 7 days prior to initiation of protocol therapy, with the exception of hydroxyurea or 6-mercaptopurine for cytoreduction.\n5. At least 20% expression of CD33 as determined by flow cytometry or immunohistochemical staining.\n6. Adequate renal function, defined as a serum creatinine less than 1.8 mg\u002FdL.\n7. Adequate hepatic function, defined as a direct bilirubin less than 2 times the institutional upper limit of normal (ULN) and AST, ALT and Alkaline Phosphatase less than 3 times the ULN.\n8. Patients who relapse after allogeneic hematopoietic stem cell transplantation are eligible, provided they are at least 60 days from stem cell infusion, do not have \\> grade 1 graft versus host disease, and have been off all immunosuppressive therapy for at least 2 weeks.\n9. Female patients of childbearing potential must have a negative pregnancy test and agree to use an adequate method of contraception as defined by the protocol. This must persist through the treatment period until at least 6 months after the last dose of chemotherapy or GO.\n10. Male subjects who are able to father children and are having intercourse with females of childbearing potential must also agree to an acceptable method of contraception through the treatment period until at least 3 months after the last dose of chemotherapy or GO, and must refrain from sperm donation during this period.\n11. Ability to give written informed consent.\n\nExclusion Criteria:\n\n1. Patients with acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase.\n2. Isolated myeloid sarcoma. Patients must have marrow involvement with AML to enter the study.\n3. Patients with known active AML involvement of the central nervous system.\n4. Prior treatment with gemtuzumab ozogamicin or cladribine for AML. Prior treatment with cytarabine is permitted.\n5. As patients will be receiving G-CSF prior to chemotherapy, patients presenting with symptomatic leukostasis (as judged by the investigator) are excluded. Hydroxyurea, 6-mercaptopurine and\u002For leukapheresis for blast count control (see inclusion criterion #4) for patients with asymptomatic hyperleukocytosis is permitted before starting treatment, but must be stopped for at least 24 hours prior to starting protocol treatment.\n6. Active uncontrolled infection. Patients on prophylactic antibacterial, antifungal, and\u002For antiviral agents and patients whose infections are controlled with these agents are eligible.\n7. Known active hepatitis B or C or other known active hepatic disorder.\n8. Any history of veno-occlusive disease (VOD)\u002Fsinusoidal obstruction syndrome (SOS).\n9. Active concurrent malignancy, unless disease-free for at least 3 years. Subjects with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been treated surgically or with definitive radiotherapy.\n10. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that per investigator's judgment would limit compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study involves evaluating a combination of chemotherapy drugs known as \"CLAG-GO\" \\[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow\u002Fstem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.",[26,27,28],"Acute Myeloid Leukemia, Adult","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, Relapsed, Adult","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2019-11-01",{"date":37,"type":20},"2028-02",{"name":39,"class":40},"University of Maryland, Baltimore","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100449545","phase-1-a-phase-b-clinical-study-of-clifutinib-besylate-combined-with-chemotherapy-in-the-treatment-of-newly-diagnosed-aml-100449545","NCT05133882","A Phase Ⅰb\u002FⅡ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML","A Phase Ib\u002FII, Multi-center, Open Clinical Trial of Crifortinib Besylate Combined With Chemotherapy in Newly-treated Adult Subjects With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1.Cohort 1: 18 years old ≤ age ≤65 years old;Cohort 2: The dose escalation trial only included AML subjects aged ≥60 years; the extended trial included subjects who were ≥60 years old or between 18 and 59 years old (including 18 and 59 years old) and could not tolerate strong chemotherapy.\n\n  2.It can be primary AML or AML secondary to MDS, and has not been treated; the extension phase requires the subject to be positive for the FLT3-ITD mutation.\n\n  3.The ECOG score according to the requirements of different groups is as follows: Cohort 1: 0\\~1 points; Cohort 2: Age ≥60 years old: 0\\~2 points; Age 18\\~59 years old (including 18 and 59 years old): 0\\~3 points.\n\n  4.Expected survival time ≥ 12 weeks. 5. Subjects must have adequate organ function. 6.subjects voluntarily participated in the study, and signed a written informed consent form by themselves or their guardians.\n\nExclusion Criteria:\n\n* 1.Diagnosed as APL and manifested as t(15;17)(q22;q12) chromosomal translocation, or BCR-ABL positive leukemia；Diagnosed as secondary to AML due to previous chemotherapy or radiotherapy of other tumors; previously received FLT3 inhibitor.\n\n  2.AML secondary to myeloproliferative tumor (MPN) or acute lymphoblastic leukemia (ALL).\n\n  3.Subjects who have infiltrated the central nervous system in the past or present.\n\n  4.Concomitant with other malignant tumors within 5 years before the first medication.\n\n  5.Thrombosis or embolism occurred within 12 months before the first medication. 6.Pulmonary function tests indicate that subjects have DLCO ≤50% or FEV1 ≤60%, or have difficulty breathing during rest or require continuous oxygen inhalation.\n\n  7.Subjects with uncontrollable, active infections。 8.Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or subjects undergoing total gastrectomy。 9.Subjects with a history of psychotropic drug abuse and unable to quit or those with mental disorders。 10.Researchers believe that those who have other severe acute or chronic diseases who are not suitable for participating in clinical trials.",{"count":50,"type":20},133,[52,23],"PHASE1","This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML",[26],"2026-05-11",{"date":57,"type":33},"2026-05-15",{"date":59,"type":33},"2022-10-31",{"date":61,"type":20},"2028-06-30",{"name":63,"class":64},"Sunshine Lake Pharma Co., Ltd.","INDUSTRY",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100629770","phase-3-azacytidine-venetoclax-plus-minus-quizartinib-for-first-line-olderunfit-aml-patients-venp-a-qui-100629770","NCT07478991","Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older\u002FUnfit AML Patients (VENP-A-QUI)","A Randomized Phase III, Global, Multicentre, Open Label Clinical Trial Comparing Venetoclax Azacytidine and Quizartinib Versus Venetoclax and Azacytidine in Newly Diagnosed Acute Myeloid Leukemia Patients Unelegible for Standard Induction Chemotherapy","VENP-A-QUI","Inclusion Criteria:\n\n1. The subject must have confirmation of AML by 2022 WHO criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline based induction regimen due to age and\u002For comorbidities.\n2. Patients must be considered ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age or co-morbidities defined by the following criteria:\n\n   * ≥ 75 years of age;\n   * or ≥ 18 to 75 years of age with at least one of the following co-morbidities:\n\n     * ECOG Performance Status of 2 or 3;\n     * Cardiac history of cardiac heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) \\>45% and ≤ 55% or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65% and\u002For significant history of chronic pulmonary obstructive;\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 50 ml\u002Fmin (see Appendix 7);\n     * Moderate hepatic impairment with total bilirubin, SGPT or SGOT \\> 1.5 to ≤ 3.0 × ULN;\n     * Non active\u002Fcontrolled prior neoplastic disease;\n     * Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the Clinical Trial Coordinator before study enrollment (e.g, prior neoplastic disease, high-risk cytogenetics). All patients aged less than 60 years old must be reviewed and approved by Clinical Trial Coordinator before study enrollment.\n3. ECOG performance status ≤2 for patients \\>75 years, ≤3 for patients ≥ 60 to 75 years of age.\n4. Male subjects who are sexually active, must agree, from Study Day 1 through at least 120 days after the last dose of study drug, to practice the protocol specified contraception.\n5. Female subjects must be either postmenopausal for at least 1 year before screening OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) or Women of Childbearing Potential (WOCBP) must agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 7 months after the last dose of study drug (female and male condoms should not be used together), or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception). Female subjects of childbearing potential must have negative results for pregnancy test performed and must not be lactating and breastfeeding.\n6. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study specific procedures, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years old at screening.\n2. Subject has received prior treatment with hypomethylating agent, FLT3 or BCL2 inhibitors.\n3. Confirmed diagnosis of prior myelodysplastic syndrome (MDS) or a myeloproliferative neoplasm (MPN) or MDS\u002FMPNs including CMML, aCML, JMML and others. This exclusion criterion will not be applicable to patients with FLT3 or NPM1 mutations (as per technical sensitivity threshold of local and\u002For central laboratory), who can be enrolled.\n4. Genetic diagnosis of acute promyelocytic leukemia.\n5. Treated (excluding surgery or hormone-therapy) for another malignancy within 6 months before randomization or previously diagnosed with another malignancy and have any evidence of disease which may compromise the administration of investigational treatment schedule.\n6. Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial.\n7. Serum creatinine ≥ 2.5 mg\u002FdL or creatinine clearance \\\u003C 30 mL\u002Fmin.\n8. Bilirubin \\>1.5 times, SGPT or SGOT \\> 3 times the upper normal limit (unless it is attributable to AML activity).\n9. WBC \\>25 x 109\u002FL before randomization.\n10. Contraindications for Azacitidine, Quizartinib or Venetoclax (such as history of hypersensitivity to any excipients in Azacitidine, Quizartinib, or Venetoclax).\n11. Known central nervous system (CNS) active leukemia, including cerebrospinal fluid positive for AML blasts.\n12. Prior treatment with any investigational drug or device within 14 days prior to Randomization (within 2 weeks for investigational or approved immunotherapy) or currently participating in other investigational interventional procedures.\n13. Known uncontrolled or significant cardiovascular disease, including any of the following:\n\n    1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker;\n    2. QTcF interval \\>450 msec;\n    3. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);\n    4. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg;\n    5. History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);\n    6. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);\n    7. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;\n    8. History of New York Heart Association Class 3 or 4 heart failure;\n    9. Known history of LVEF ≤45%;\n    10. Complete left bundle branch block;\n    11. Severe aortic stenosis\n14. Prior therapy for AML (except hydroxyurea, or maximum 1 gram\u002Fsqm\u002Fday per 2 days of cytarabine allowed to control hyperleukocytosis during the screening period).\n15. Subject must not have consumed grapefruit, grapefruit products, Seville oranges (including marmalade-containing Seville oranges), or star fruit within 3 days before anticipated first dose of Venetoclax and must consent not to consume through the last dose of Venetoclax.\n16. Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy at physician discretion.\n17. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C)\n18. Known history of human immunodeficiency virus (HIV).\n19. Uncorrected Grade 3 or 4 hypokalemia, hypomagnesemia or hypocalcemia (Subjects with Grade 1 or 2 electrolyte abnormalities can be enrolled while electrolytes are being corrected).\n20. Uncontrolled hypothyroidism.",{"count":74,"type":20},376,[76],"PHASE3","The goal of this clinical trial is to learn if Venetoclax+Azacytidine+Quizartinib works better than standard therapy (Venetoclax+Azacytdine) to treat naïve adult patients with acute myeloid leukemia (AML) who are not suitable for standard induction therapy due to age, co-morbidities or other risk factors. The main question it aims to answer is:\n\n\\- Does the combination of Venetoclax+Azacytidine+Quizartinib show more probability of overall survival than Venetoclax+Azacytdine?\n\nResearchers will compare Venetoclax+Azacytidine+Quizartinib to Venetoclax+Azacytdine to see if Venetoclax+Azacytidine+Quizartinib works better than Venetoclax+Azacytdine to treat AML.\n\nParticipants will be randomized to one of the two treatment arms in a 1:1 ratio, both of which will have treatment cycles of 28 days.",[26],[80,81,82],"AML","adult","old\u002Funfit","NOT_YET_RECRUITING","2026-03-13",{"date":86,"type":33},"2026-03-18",{"date":88,"type":20},"2026-03",{"date":90,"type":20},"2030-04",{"name":92,"class":40},"PETHEMA Foundation",51,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":41},"100557010","phase-2-comparison-of-va-venetoclax-azacitidine-vacl-va-cladribine-vach-va-chidamide-and-alternating-vaclvach-in-newly-diagnosed-acute-myeloid-leukemia-100557010","NCT06532552","Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl\u002FVACh in Newly Diagnosed Acute Myeloid Leukemia","Comparison of VA (Venetoclax, Azacitidine), VACl (VA, Cladribine), VACh (VA, Chidamide), and Alternating VACl\u002FVACh in Newly Diagnosed Adult Acute Myeloid Leukemia Patients Ineligible for Intensive Therapy or Declining: A Prospective, Multi-center, Randomized, Controlled Phase II Study","Inclusion Criteria:\n\nA subject will be eligible for study participation if he\u002Fshe meets the following criteria within 21 days prior to randomization.\n\n1. Subject must have confirmation of previously untreated AML by World Health Organization (WHO) criteria, and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities. Prior therapy with hydroxyurea or a total dose of cytarabine no more than 0.5g (for emergency use for stabilization) is allowed.\n2. Subject must be≥18 years of age with at least one of the following conditions:\n\n   A)≥60 years of age; B) Patients aged \\\u003C 60 years who are unsuitable for standard induction therapy（Any other comorbidity that the physician judges to be incompatible with conventional intensive chemotherapy); C) The patient refused the conventional intensive chemotherapy.\n3. Adequate organ function as defined below:\n\n   A)liver function (bilirubin≤2mg\u002FdL, aspartate transaminase (AST) and\u002For alanine transaminase (ALT)≤3 x ULN).\n\n   Unless liver enzyme abnormalities are determined by the treating MD and PI to be due to leukemic infiltration.\n\n   B)kidney function (creatinine≤1.5xULN ).\n4. ECOG performance status of ≤ 2.\n5. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n6. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n7. Patient must have a projected life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n1. Subject has a history of other malignancies prior to study entry, with the exception of:\n\n   A) Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; B) Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; C) Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.\n2. Subject has acute promyelocytic leukemia, subject has history of myeloproliferative neoplasm \\[MPN\\] including myelofibrosis, essential thrombocythemia, polycythemia vera, CML with or without BCR-ABL1 translocation, BCR\u002FABL positive AML.\n3. Patient has known active central nervous syster (CNS) involvement with AML.\n4. Subject has a white blood cell count\\> 25×10\\^9\u002FL. (Hydroxyurea is permitted to meet this criterion.)\n5. Prior therapy with venetoclax, Cladribine, hypomethylating agents (HMAs), Chidamide or Chimeric Antigen Receptor T cell therapy, experimental therapies for MDS or AML.\n6. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration.\n7. Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required.)\n8. Subject has received strong and\u002For moderate CYP3A inducers within 7 days prior to the initiation of study treatment.\n9. Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.\n10. 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.\n11. Subject has chronic respiratory disease that requires continuous oxygen, or 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.\n12. Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal).\n13. 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 anti-HBs+-\\] may participate)",{"count":102,"type":20},172,[23],"This prospective, multi-center, randomized, controlled Phase II study is to compare the therapeutic efficacy and side effect of VACl (Venetoclax,Azacitidine,Cladribine) alternating with VACh (Venetoclax,Azacitidine,Chidamide), VACl, VACh and VA in newly diagnosed adult acute myeloid leukemia (AML) patients ineligible for intensive therapy or declining. Cladribine is a purine analogue widely used in hematologic malignancies. The monocytic leukemia stem cell is selective sensitivity to Cladribine. Chidamide, a newly designed selective histone deacetylase inhibitor, could down regulate myeloid cell leukaemia 1 (MCL1) expression in Venetoclax resistant AML cells. Chidamide or Cladribine have synergistic anti-leukemia effects with VA through their unique mechanisms, which can eradicate leukemia stem cells and prevent the occurrence of drug resistance.",[26,106],"Newly Diagnosed",[108,109,110,111],"Venetoclax","Azacitidine","Cladribine","Chidamide","2025-11-18",{"date":114,"type":33},"2025-11-19",{"date":116,"type":33},"2024-07-29",{"date":118,"type":20},"2028-08-01",{"name":120,"class":40},"The First Affiliated Hospital of Soochow University",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"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":130,"type":20},397,"OBSERVATIONAL","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.",[134,135,26],"Acute Myeloid Leukemia","AML, Adult","2025-08-08",{"date":138,"type":33},"2025-08-13",{"date":140,"type":33},"2025-07-11",{"date":142,"type":20},"2029-12",{"name":144,"class":40},"Gruppo Italiano Malattie EMatologiche dell'Adulto",2,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":41},"100531419","phase-1-a-study-to-investigate-treatment-of-hu-and-vpa-or-6-mp-and-vpa-in-unfit-amlhr-mds-patients-100531419","NCT06199557","A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML\u002FHR-MDS Patients","A Phase 1\u002F2 Multicenter Open-label Study to Investigate Treatment of Hydroxyurea in Combination With Valproic Acid (VPA), or 6- Mercaptopurine in Combination With VPA in Patients With AML or HR-MDS Unfit for Standard Therapy","HUVAMER","Inclusion Criteria:\n\nParticipants are eligible for the study only if all of the following criteria apply:\n\no Female or male, age 18 years or older\n\n* Written informed consent\n* Patients with Newly diagnosed AML, as defined by ELN 2022 criteria, or relapsed\u002Frefractory AML who: - are unfit, defined as HCT-CI ≥ 3, or - in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n\n  * the patient has declined standard therapy\n\nNewly diagnosed HR-MDS, or relapsed\u002Frefractory HR-MDS who:\n\n* are unfit, defined as HCT-CI ≥ 3, or\n* in the opinion of the investigator are not candidates for standard therapy or unlikely to tolerate or derive significant clinical benefit from standard therapy, or\n* has declined standard therapy\n\nSecondary AML (MDS-related\u002F therapy- induced), or\n\nAcute promyelocytic leukemia not eligible for standard therapy and\u002For specific therapy.\n\n* Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:\n\n  * Serum creatinine ≤1.5 x ULN;\n  * Estimated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault equation);\n  * Hepatic function;\n\n    i. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN); ii. Aspartate aminotransferase (AST)\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iii. Alanine aminotransferase (ALT)\n\n    \u003C!-- -->\n\n    1. ≤2.5 × ULN\n    2. ≤5 × ULN for patients with liver metastases\n\n       iv. Alkaline phosphatase (ALP)\n\n    1\\. ≤2.5 × ULN\n* European Cooperative Oncology Group (ECOG) performance status 0, 1, 2 or 3\n* Female patients of childbearing potential must have a negative serum pregnancy test within 3 days prior to taking their first dose of study medication. Male patients and female patients of reproductive potential must agree to practice highly effective methods of contraception (such as hormonal implants, combined oral contraceptives, injectable contraceptives, intrauterine device with hormone spirals, total sexual abstinence, vasectomy) throughout the study and for \\>3 months after the last dose of study medication. Female patients are considered NOT of childbearing potential if they have a history of surgical sterility or evidence of post-menopausal status defined as any of the following:\n\n  1. Natural menopause with last menses \\>1 year ago\n  2. Radiation induced oophorectomy with last menses \\>1 year ago\n  3. Chemotherapy induced menopause with last menses \\>1 year ago\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Patients on treatment for AML (any anti-leukemic therapy including investigational agents) or treated less than 2 weeks before inclusion.\n* Concurrent history of active malignancy in the past six months prior to diagnosis except for\n\n  * basal and squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease et cetera) at the investigators discretion.\n* Breastfeeding women\n* Cardiac dysfunction as defined by:\n\n  * myocardial infarction within the last 3 months of study entry, or\n  * congestive heart failure NYHA class IV or\n  * unstable angina, or\n  * unstable cardiac arrhythmias\n* SARS-CoV-2 infection \\\u003C 7 days or Covid-19-vaccine \\\u003C 7 days from study onset\n* Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.\n* Patients with any serious concomitant medical condition that could, in the opinion of the investigator, compromise participation in the study.\n* Patients with 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 as specified in the protocol.\n* Known hypersensitivity to study medications or its excipients.\n* Any psychological, familial, sociological, and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.",{"count":155,"type":20},48,[52,23],"The purpose of this study is to investigate the safety, tolerability, and preliminary efficacy of the combination treatment of hydroxyurea capsules and valproic acid capsules, or the combination treatment of 6-mercaptopurine tablets and valproic acid capsules in male and female patients aged 18 years or older with acute myeloid leukemia or high- risk myelodysplastic syndrome.\n\nThe population to be studied is newly diagnosed AML patients who are considered unfit for standard induction chemotherapy, HR-MDS unfit\u002Fineligible for standard treatment, and relapsed\u002Frefractory AML\u002FHR-MDS patients who are considered unfit for standard therapy ,or are, for some reason, ineligible for another type of therapy. Clinically, hydroxyurea, valproic acid and 6-mercaptopurine are historically very well-known therapeutic agents with low toxicity profiles. The rationale for this study is that the combination of these drugs with low toxicity will be well tolerated in elderly AML patients with comorbidities, or lower performance status. This combination could have a beneficial therapeutic effect on overall survival and contribute to a better quality of life.",[26,159],"Myelodysplastic Syndromes, Adult","2025-06-25",{"date":162,"type":33},"2025-06-29",{"date":164,"type":33},"2024-05-23",{"date":166,"type":20},"2029-09-30",{"name":168,"class":40},"Haukeland University Hospital",{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100566227","phase-3-revumenib-in-combination-with-azacitidine--venetoclax-in-patients-npm1-mutated-or-kmt2a-rearranged-aml-100566227","NCT06652438","Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML","Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n1. Patient with newly diagnosed NPM1-mutated AML, consistent with NPM1c, according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts).\n\n   OR Patient with newly diagnosed KMT2A-rearranged AML according to the 2022 International Consensus Classification (i.e. ≥ 10% blasts). KMT2A partial tandem duplications or deletions are NOT eligible.\n\n   Of note: in case both NPM1 and IDH1 are mutated and both EVOLVE-1 (HO173) and EVOLVE-2 (HO177) are open for inclusion at your site, then patients can only be included in the EVOLVE-1 trial (HO173)\n2. Central confirmation of NPM1 mutation or KMT2A rearrangement in one of the dedicated central genetic laboratories.\n3. Age ≥ 18 years, no upper age limit.\n4. Patient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria:\n\n   * ≥ 75 years of age: ineligible for intensive chemotherapy per physician's discretion (with an ECOG performance status 0-2) .\n   * 18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities: o ECOG performance status 2 or 3 .\n\n     * Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina.\n     * DLCO ≤ 65% or FEV1 ≤ 65%.\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C45 ml\u002Fmin calculated by the Cockcroft Gault formula.\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to \\\u003C 3.0 x upper limit of normal (ULN).\n     * Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy must be reviewed and approved by the Sponsor's (co-) Principal Investigator (written approval must be sent to HO177@erasmusmc.nl before study enrolment).\n5. Patient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician).\n6. Patient must have a white cell blood (WBC) count of \\\u003C 25 x 109\u002FL. Hydroxyurea can be used prior to study enrolment to reduce the WBC count to meet this criterion.\n7. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \\>30 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate (GFR).\n8. Adequate hepatic function as evidenced by:\n\n   * Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert's disease, or leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n   * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following written approval by the sponsor (Co-)Principal Investigator (copy in HO177@erasmusmc.nl).\n9. Female patient must:\n\n   * be of nonchildbearing potential:\n\n     o postmenopausal (defined as at least 1 year without any menses).\n\n     o documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening).\n   * or, if of childbearing potential (not surgically sterile and not postmenopausal) agree to avoid pregnancy during the study and for 6 months after the final study drug administration.\n\n     o and have a negative urine or serum pregnancy test at screening.\n\n     o and, if heterosexually active, agree to consistently apply one highly effective\\* method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.\n\n     \\*Highly effective forms of birth control include\n\n     \\- Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \\[estrogen and progestogen containing\\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used.\n\n     \\- Established intrauterine device (IUD) or intrauterine system (IUS)\n\n     \\- Bilateral tubal occlusion\n     * Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n     * Male is sterile due to a bilateral orchiectomy.\n     * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.\n\n   List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period.\n   * agree not to breastfeed starting at screening and throughout the study period.\n   * agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.\n10. Men must use a latex condom during any sexual contact with women of childbearing potential (WOCBP), even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.\n11. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n12. Able to understand and willing to sign an informed consent form (ICF).\n13. Institutional Review Board\u002FIndependent Ethics Committee-approved written informed consent as per national regulations must be obtained from the patient prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable).\n\nExclusion Criteria:\n\nSubject has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed.\n\n2\\. Acute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations \u002F fusion genes. 3. AML with BCR-ABL1; or myeloid blast crisis of CML. 4. Significant active cardiac disease within 3 months prior to the start of study treatment, including:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure\n* Myocardial infarction\n* Unstable angina\n* Severe cardiac arrhythmias\n* Congenital long QT syndrome of family member with this condition QTcF \\>450 msec on screening electrogram for males and \\>470msec on screening electrogram for females (mean of triplicate recordings; calculated using Fridericia's correction). 5. Severe obstructive or restrictive ventilation disorder. 6. History of stroke or intracranial hemorrhage within 6 months prior to randomization.\n\n  7\\. Clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening. 8. Active infection, including hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic\u002F antiviral\u002F antifungal treatment that is not a strong or moderate CYP3A inducer is allowed. Patients with COVID-19 infection can be enrolled, if the patient has no symptoms and was tested negative twice by PCR test prior to inclusion in the trial. 9. Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and\u002For disseminated intravascular coagulation. 10. Conditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n\n  11\\. Patient with a currently active second malignancy. Patients are not considered to have a currently active malignancy, if they have completed therapy and are considered by their physician to be at \\\u003C 30% risk of relapse within one year. However, patients with the following history\u002Fconcurrent conditions are allowed:\n* Basal or squamous cell carcinoma of the skin;\n* Carcinoma in situ of the cervix;\n* Carcinoma in situ of the breast;\n* Incidental histologic finding of prostate cancer. 12. Receipt of live, attenuated vaccine within 30 days prior to the study inclusion (NOTE: patient, if enrolled, should not receive live vaccine during the study and until 6 months after the therapy).\n\n  13\\. Severe neurological or psychiatric disorder interfering with ability to give an informed consent.\n\n  14\\. Known or suspected hypersensitivity to any of the anti-leukemic agents used.\n\n  15\\. Participation in other prospective studies with anti-leukemic and\u002For investigational agents.\n\n  16\\. Patient taking Dabigatran unless they can be transferred to other medications within ≥5 half-lives prior to dosing. Patients taking other P-gP transporter-sensitive medications (see Appendix H) should be properly monitored during the study if they cannot be transferred to other medications.\n\n  17\\. Patient taking known strong cytochrome P450 (CYP) 3A4 inducers , unless they can be transferred to other medications within ≥5 half-lives prior to dosing. The patient is a pregnant or lactating woman, or plans to become pregnant during the study.\n\n  19\\. Patient who has once been screened and randomized into this HO177 trial but was considered ineligible cannot re-enter this trial at a later date.",{"count":177,"type":20},415,[76],"Treatment of patients with newly diagnosed AML who are not eligible for intensive chemotherapy has remained an area of high unmet medical need. The combination therapy with two medicines, azacitidine and venetoclax, is the usual plan of action. This has brought significant progress in the treatment, but it nevertheless is not curative and the disease does relapse over time.\n\nRevumenib blocks a specific molecule called menin in the cell nucleus. Some types of AML are reliant on menin working properly. These are leukemia cells with a change in the DNA, i.e. a mutation in the NPM1 or KMT2A gene. Revumenib can prevent the production of these types of leukemia cells by disrupting the production of this menin.\n\nThe current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene.\n\nThis is a randomized, double-blind, placebo-controlled clinical study where subjects will be treated until disease progression, or development of side effects or death. From the moment of inclusion of the last patient, there will be a 4-year observational follow-up study in order to register survival duration and follow-up visits.\n\nApproximately 415 previously untreated patients with a mutation in the NPM1 or KMT2A gene and with newly diagnosed AML, who are not eligible for intensive chemotherapy. Patients must be ≥18 years of age.",[26],[182,183,184],"newly AML diagnosed","NPM1","KMT2A","2025-04-03",{"date":187,"type":33},"2025-04-04",{"date":189,"type":33},"2025-03-31",{"date":191,"type":20},"2031-07-10",{"name":193,"class":40},"Stichting Hemato-Oncologie voor Volwassenen Nederland",67,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100485488","phase-1-first-in-human-study-aiming-to-characterize-the-safety-tolerability-pharmacokinetic-and-preliminary-signs-of-activity-of-abd-3001-in-refractory-or-relapsed-aml-and-high-risk-mds-adult-patients-100485488","NCT05601726","First-in-human Study Aiming to Characterize the Safety, Tolerability, Pharmacokinetic and Preliminary Signs of Activity of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients","First-In-Human, Open Label, Dose Escalation Study to Evaluate Safety, PK and PD of ABD-3001 As Monotherapy in Relapsed\u002FRefractory Acute Myeloid Leukemia or High\u002FVery-high Risk Myelodysplastic Syndromes Patients, Ineligible for Intensive or New Generation Targeted Therapy.","ODYSSEY","Inclusion Criteria:\n\n* Patients with relapsed\u002Frefractory Acute Myeloid Leukemia (AML) after failing at least one therapy regimen and a salvage treatment or are not eligible for salvage treatment regimens including targeted therapy\n* Patients with relapsed\u002Frefractory Myelodysplastic syndrome (MDS) ineligible for salvage treatment who are diagnosed high-risk and very high-risk using Revised International Prognostic Scoring System (IPSS-R) prognostic risk categorization\n* Patients not eligible to alloSCT\n* Negative blood or serum\u002Furine pregnancy test\n\nExclusion Criteria:\n\n* Patients with acute myeloid leukemia (AML) with Inv(16) MYH11-CBF-Beta or t(8;21) AML-ETO RUNX1-RUNX1 or (PML\u002FRARA) karyotype abnormalities and eligible to targeted therapies\n* Participants with clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia\n* Ongoing immunosuppressive treatment\n* Hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1\n* Active infection requiring intravenous anti-infectious treatment during the screening period\n* Life-threatening illnesses other than the studied one, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities\n* Anti-tumor therapy within 14 days of study Visit 1\n* Prior participation in an interventional investigational clinical study (drug or medical device) within 21 days of study Visit 1\n* Radiotherapy within 28 days prior to study Visit 1\n* Current history of seropositivity to human immunodeficiency virus (HIV) or infection with active hepatitis C virus (HCV) or active hepatitis B virus (HBV) or active SARS-CoV-2 (Covid-19) or Syphilis, or Cytomegalovirus (CMV), or Epstein-Barr virus (EBV), or Human T-Lymphotropic Virus (HTLV1)\n* History of other malignancy in the last 12 months prior to study Visit 1\n* Other active solid tumor\n* Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or Left Ventricular Ejection Fraction (LVEF) \\\u003C50% attested by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days of C1D1 prior to study Visit 1 (Day 1, start of study therapy)\n* Subjects with a history of myocardial infarction within the last 3 months prior to study Visit 1 (Day 1, start of study therapy)\n* Subjects with heart-rate corrected QT (QTc) interval ≥450 ms or other factors that increase the risk of QT prolongation or arrhythmic events\n* Major surgery within 4 weeks prior to study Visit 1 (Day 1, start of study therapy)\n* Any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial MAD specific exclusion criteria: Patients who have been part of SAD and have experienced a DLT.",{"count":204,"type":20},36,[52,23],"This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design. It will consist in a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part.",[26,208],"Myelodysplastic Syndromes",[26,210,211,212],"Myelodysplastic syndromes","First in Human","ABD-3001","2025-01-17",{"date":215,"type":33},"2025-01-20",{"date":217,"type":33},"2022-11-08",{"date":219,"type":20},"2026-12",{"name":221,"class":64},"Advanced BioDesign",3,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":41},"100493282","clinical-and-diagnostic-significance-of-endothelial-dysfunction-and-myocardial-contractility-in-patients-with-aml-100493282","NCT05703126","Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With AML","Clinical and Diagnostic Significance of Endothelial Dysfunction and Myocardial Contractility in Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* patients with acute myeloid leukemia receiving anthracycline-containing polychemotherapy regimens aged 18 to 65 years, without clinical signs of heart failure, with an LV ejection fraction of more than 50% before starting chemotherapy;\n* availability of informed consent of the patient to participate in the study.\n\nExclusion Criteria:\n\n* acute violation of cerebral circulation in history;\n* a history of myocardial infarction;\n* the presence of diabetes mellitus type I and II;\n* the presence of chronic kidney disease C1-C5 stages;\n* the presence of stable angina III-IV functional classes;\n* the presence of unstable angina pectoris;\n* the presence of atrial fibrillation and flutter;\n* the presence of arterial hypertension of 2-3 degrees;\n* the presence of other oncological diseases;\n* inflammatory diseases in the acute stage;\n* diseases of the thyroid gland;\n* therapy with any monoclonal antibodies in history;\n* a positive test for the presence of HIV and hepatitis B and C;\n* alcoholism, drug addiction;\n* the presence of neuroleukemia, extramedullary foci of leukemia;\n* refusal of the patient to be examined.\n* the emergence of life-threatening situations during the study;\n* development in patients of diseases related to the non-inclusion criteria;\n* refusal of the patient to further examination.","65 Years",{"count":232,"type":20},100,[234],"NA","Acute myeloid leukemia (AML) is a clonal neoplastic disease of the hematopoietic tissue associated with a mutation in the precursor cell of hematopoiesis, which results in a differentiation block and uncontrolled proliferation of immature myeloid cells.\n\nAnthracycline antibiotics have been an integral part of the treatment of acute myeloid leukemia since the 1970s. However, the clinical usefulness of anthracyclines is limited primarily by the high incidence of cardiotoxicity. According to the European Society of Cardiology guidelines for cardio-oncology, cardiovascular toxicity is defined as any impairment of cardiac function associated with anticancer treatment, as the term encompasses both a wide range of possible clinical manifestations and an etiological relationship with various treatments, including chemotherapy, radiation therapy, immunotherapy and treatment with targeted drugs. Cardiovascular toxicity can be acute, subacute or delayed, manifesting many years after chemotherapy or radiation therapy, involving a number of cardiac structures, which can lead to the development of heart failure, coronary heart disease, valvular heart disease, arrhythmias, including cardiac conduction disorders and diseases of the pericardium.\n\nAnthracycline-induced cardiotoxicity is the negative effect of anthracyclines on normal cardiac activity due to their toxic effects on the heart muscle and the cardiac conduction system. Anthracycline-induced cardiotoxicity manifests as asymptomatic left ventricular dysfunction in 57% of treated patients and restrictive or dilated cardiomyopathy leading to congestive heart failure (CHF) in 16% to 20% of patients. Anthracycline-induced congestive heart failure is often resistant to therapy and has a mortality rate of up to 79%. Thus, there is a need for early detection of cardiovascular dysfunction associated with chemotherapy treatment of acute myeloid leukemia in order to timely prescribe drug therapy.\n\nPurpose of the study To optimize the early detection of endothelial dysfunction and left ventricular myocardial contractility in patients with acute myeloid leukemia during chemotherapy treatment based on a comprehensive assessment of instrumental and laboratory research parameters.\n\nExpected results Based on a comprehensive analysis using laser Doppler flowmetry, stress echocardiography with the determination of global longitudinal strain of the myocardium, biochemical markers of endothelial damage and cardiac biomarkers, a correlation between violations of the contractility of the left ventricular myocardium and violations of the vasoregulatory function of the vascular endothelium will be revealed, which will allow developing an algorithm for early detection of cardiomyopathy and vascular complications in patients with acute myeloid leukemia during chemotherapy treatment.",[26,237,238],"Cardiotoxicity","Endothelial Dysfunction",[134,237,238,240,241],"Polychemotherapy","Anthracyclines","2024-11-02",{"date":244,"type":33},"2024-11-05",{"date":246,"type":33},"2022-12-01",{"date":248,"type":20},"2025-08-03",{"name":250,"class":40},"Samara State Medical University",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100535496","phase-1-multi-peptide-vaccination-adjuvanted-with-xs15-in-acute-myeloid-leukemia-patients-100535496","NCT06252584","Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients","Multi-peptide Vaccination Adjuvanted With the TLR1\u002F2 Ligand XS15 in Acute Myeloid Leukemia (AML) Patients Who Have Achieved Complete Remission With First Line Therapy","AML-VAC-XS15","Inclusion Criteria:\n\n* Males or females aged ≥18 years of age\n* Existence of a written informed consent\n* Documented diagnosis of AML according to WHO guidelines\n\n  * morphological complete remission (CR) or complete remission with incomplete blood count recovery (CRi)\n  * positive MRD is permitted\n  * completion of previous intensive therapy (first vaccination 4-28 weeks after last application of chemotherapy) or\n  * ongoing low intensity treatment with e.g. hypomethylating agents (HMA), venetoclax, etc.\n  * ongoing maintenance treatment with e.g. oral azacytidine or midostaurin is permitted.\n  * not eligible for allogeneic stem cell transplantation\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2\n* Adequate organ function laboratory values.\n\n  * bilirubin ≤ 3 times upper limit range (exception isolated indirect hyperbilirubinemia (Morbus Gilbert-Meulengracht)).\n  * alanine aminotransferase (ALT) and aminotransferase (AST), ≤ 5 times upper limit range\n  * creatinine clearance GFR \\> 30 ml\u002Fmin (CKD-EPI)\n  * platelets \\> 50.000\u002Fμl\n  * absolute CD3+ T cell count ≥ 200\u002Fμl\n* negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion\n* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception (for more detailed information see chapter 5.7 Contraception, pregnancy, sperm donation and nursing). This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last vaccination).\n* For FCBP two negative pregnancy tests (sensitivity of at least 25 mlU\u002FmL) prior to first application of first vaccination, one at screening and the other prior (\\\u003C 24 h) to first vaccination\n* Postmenopausal or evidence of non-child-bearing status\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted).\n* Concurrent or previous treatment within 28 days in another interventional clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints.\n* Major surgery within 28 days of dosing of study drug.\n* Treatment with immunotherapy agents within 28 days of dosing of study drug.\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (\\\u003C 10 mg\u002F day), in the past 1 year.\n* Prior history of malignancies, other than AML\u002Fmyelodysplastic syndrome (MDS), unless the subject has been free of the disease for\n\n  ≥ 2 years. Exceptions include the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, histological finding of prostate cancer of TNM stage T1\n* Prior stem cell allograft or organ transplantation\n* Ongoing or active infection (including SARS-CoV-2)\n* Have received any live vaccination within 28 days prior to the first dose of AML-VAC-XS15.",{"count":260,"type":20},20,[52],"The aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1\u002F2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.",[26],[265],"acute myeloid leukemia","2024-02-01",{"date":268,"type":33},"2024-02-09",{"date":270,"type":20},"2024-05-02",{"date":272,"type":20},"2026-11-02",{"name":274,"class":40},"University Hospital Tuebingen"]