[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelodysplastic-syndrome-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelodysplastic-syndrome-acute-myeloid-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"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":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100648243","phase-1-a-study-to-evaluate-s241656-alone-or-in-combination-in-participants-with-selected-myeloid-malignancies-100648243",false,"NCT07719348","A Study to Evaluate S241656 Alone or in Combination in Participants With Selected Myeloid Malignancies","A Phase 1\u002F2, Open Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination With Other Antileukemic Agents in Participants With Selected Myeloid Malignancies","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Investigator-assessed life expectancy of ≥ 3 months.\n* Able and willing to comply with requirements of the study protocol.\n* Documented genetic characterization of the disease as per local practice.\n* Clinical and laboratory thresholds:\n* Cytoreduction: white blood cell (WBC) \\\u003C 25 × 10⁹\u002FL (hydroxyurea\u002Fcytarabine\u002Fleukapheresis allowed).\n* Renal: creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (Cockcroft-Gault).\n* Hepatic: aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (5 × if leukemic); Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome).\n* Part 1 Only: Relapsed\u002FRefractory (R\u002FR), pathologically confirmed AML, MDS\u002FAML, or CMML.\n* Part 1 Only: Must have failed ≥ 1 approved standard therapy and have no other approved standard options.\n\nExclusion Criteria:\n\n* Known hypersensitivity to S241656, or Posaconazole (Part 1B).\n* Pregnant or breastfeeding; positive serum pregnancy test for WOCBP.\n* Diagnosis of acute promyelocytic leukemia (French-American-British \\[FAB\\] M3 classification), MPN, mixed\u002Fambiguous lineage, histiocytic\u002Fdendritic cell neoplasms, or AML with isolated extramedullary disease (no marrow\u002Fblood involvement).\n* Active Central Nervous System (CNS) disease (by cytologic or radiographic evidence).\n* Failure to recover to ≤ Grade 1 from previous toxicities (except Grade 2 neuropathy\u002Falopecia).\n* Major surgery within 4 weeks.\n* Any anticancer therapy within 2 weeks or 5 half-lives (28 days for biologics). Cytoreduction with hydroxyurea or cytarabine is permitted.\n* Prior use of experimental KRAS\u002FBRAF\u002FMEK\u002FERK inhibitors (prior FLT3 inhibitors are permitted).\n* Uncontrolled infections (human immunodeficiency virus (HIV)\u002Fhepatitis B virus (HBV)\u002Fhepatitis C virus (HCV) permitted only if viral load is undetectable\u002Fcontrolled and specific cluster of differentiation 4 (CD4)+ criteria are met).\n* Malabsorption, Crohn's, or chronic vomiting that impacts oral drug absorption.\n* History\u002Frisk of retinal vein occlusion (RVO), glaucoma, or hyper-viscosity syndromes.\n* Other active malignancy requiring systemic therapy within 2 years (except non-melanoma skin cancer or localized\u002Fcured tumors).\n* Stroke, myocardial infarction (MI), unstable angina, or acute coronary syndrome within 6 months.\n* Congestive heart failure (CHF), clinically significant cardiac arrhythmias according to the investigator's judgement (e.g., ventricular tachycardia), complete left bundle branch block and high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II- and third degree AV block).\n* Fridericia-corrected QT interval (QTcF) \\> 470 msec or history of Torsades de pointes.\n* Disseminated intravascular coagulation (DIC), significant coagulopathy according to the investigator's judgement, or uncontrolled bleeding.\n* Proton Pump Inhibitors (PPIs) and potassium-competitive acid blockers ≥ 7 days prior to Cycle 1 Day 1.\n* Breast cancer resistance protein (BCRP) sensitive substrate or with a narrow therapeutic index (NTI)\n* All herbal preparations\u002Fsupplements are prohibited.","ALL","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of S241656 and to determine the recommended dose for expansion (RDE) of S241656 in participants with relapsed\u002Frefractory (R\u002FR) acute myeloid leukemia (AML), myelodysplastic syndrome\u002Facute myeloid leukemia (MDS\u002FAML), or chronic myelomonocytic leukemia (CMML). Part 1A dose escalation will determine the RDE to be used in a future expansion stage of the trial. An optional Part 1B drug-drug interaction (DDI) substudy will evaluate the effect of posaconazole on the PK of S241656.\n\nThe study consists of a screening period of up to 21 days, a treatment period consisting of continuous 28-day cycles of treatment, an end-of-treatment visit, a safety follow-up period, and long-term disease and survival follow-up every 3 months. Participants in the optional DDI substudy may continue treatment in the main study following completion of the DDI assessment period. Participants may undergo bone marrow aspirates and\u002For biopsies, blood tests, electrocardiograms (ECGs), echocardiograms or multigated acquisition (MUGA) scans, physical examinations, ophthalmologic assessments, and disease response questionnaires.",[27,28,29],"Acute Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-07-17",{"date":33,"type":34},"2026-07-22","ACTUAL",{"date":36,"type":20},"2026-09-15",{"date":38,"type":20},"2030-09-30",{"name":40,"class":41},"Servier","INDUSTRY",{"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":52,"conditions":53,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100544732","phase-1-a-study-to-investigate-apl-4098-alone-and-in-combination-in-adults-with-aml-or-mds-100544732","NCT06372717","A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS","A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome\u002FAML (MDS\u002FAML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R\u002FR AML), myelodysplastic syndrome (MDS)\u002F AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R\u002FR AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.\n* WBC count ≤ 25,000\u002Fmicroliter\n* ECOG Performance Status of ≤ 2\n* Weight ≥ 40kg\n* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse\n* Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study\n* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial\n\nExclusion Criteria:\n\n* Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening\n* Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening\n* Diagnostic assessments: Left ventricular ejection fraction \\\u003C 45%, Fridericia's corrected QT interval \\> 470msec, Aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 x upper limit of normal (ULN), total bilirubin \\> 1.5 x ULN, calculated or measured creatinine clearance \\\u003C 45 mL\u002Fminute (multiply by 0.85 if female)\n* Infectious disease: HIV positive, active hepatitis B and\u002For C",{"count":50,"type":20},100,[23],"This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)\u002FAML and MDS-excess blasts (EB).",[54,29,55,56,57],"Acute Myeloid Leukemia Refractory","Myelodysplastic Syndrome With Excess Blasts","Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia (AML)","RECRUITING","2026-05-29",{"date":61,"type":34},"2026-06-01",{"date":63,"type":34},"2024-06-04",{"date":65,"type":20},"2027-05-01",{"name":67,"class":41},"Apollo Therapeutics Ltd",9,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100455516","phase-1-ab8939-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100455516","NCT05211570","AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1\u002F2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous AB8939 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","DOSE ESCALATION STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* Patients with documented diagnosis of refractory melyodisplastic syndrome in second or third line of treatment, and with high risk at prognosis based on the IPSS-R scoring system.\n* ECOG performance status ≤ 1\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply\n\nEXPANSION COHORT STUDY\n\nKey Inclusion Criteria:\n\n* Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment.\n* ECOG performance status ≤ 2\n* Patients are able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures\n* Patients are able and willing to comply with study procedures as per protocol, including bone marrow biopsies\n\nKey Exclusion Criteria:\n\n* Patients eligible to a standard of care\n* Patients eligible to hematopoietic stem cell transplantation (HSCT) at the time of inclusion\n* Patients diagnosed with acute promyelocytic leukemia (M3)\n* Patients with clinically active CNS leukemia\n* Patients with HSCT within 100 days prior to the first administration of AB8939\n* Women who are lactating\u002Fbreastfeeding or who plan to breastfeed while on study\n* Women with a positive pregnancy test\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":77,"type":20},78,[23,24],"The primary objective is to define the safety and tolerability of AB8939 in patients with AML by determining the dose-limiting toxicities, the maximum tolerated dose, and the recommended dose for dose expansion study.",[54,56,29],"2025-09-29",{"date":83,"type":34},"2025-10-02",{"date":85,"type":34},"2022-06-01",{"date":87,"type":20},"2026-12",{"name":89,"class":41},"AB Science",10]