[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oryzon Genomics S.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100481252",false,"NCT05546580","Study of Iadademstat and Gilteritinib in Patients With R\u002FR AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)","An Escalation\u002FExpansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study","FRIDA","Main Inclusion Criteria:\n\n* Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)\n* Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.\n* Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months in the opinion of the investigator.\n* Normal hepatic and renal function.\n* Patient is able to swallow oral medications.\n* Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.\n* Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.\n\nMain Exclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia.\n* Known BCR-ABL-positive leukemia.\n* AML secondary to prior chemotherapy for other neoplasms (except for MDS).\n* AML that has relapsed after or is refractory to more than 2 lines of therapy.\n* Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.\n* Major surgery or radiation therapy within 4 weeks prior to the first study dose.\n* Prior treatment with iadademstat is not allowed. Treatment with any other agents with KDM1A\u002FLSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study. Previous treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and\u002For maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and\u002For maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.\n* Patients not eligible to receive gilteritinib per label.\n* Prior treatment with 3 or more lines of AML therapy.\n* Treatment with any investigational products within 3 weeks prior to first dose of study treatment.\n* Uncontrolled hypertension or poorly controlled diabetes.\n* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.\n* Pregnant or lactating women.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R\u002FR AML.",[26,27],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[29],"Acute Myeloid Leukemia, FLT3 mut","RECRUITING","2024-07-26",{"date":33,"type":34},"2024-07-29","ACTUAL",{"date":36,"type":34},"2022-11-14",{"date":38,"type":20},"2025-11-30",{"name":40,"class":41},"Oryzon Genomics S.A.","INDUSTRY",13,""]