[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"c-kit-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:c-kit-mutation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100540447","phase-2-safety-and-efficacy-of-avapritinib-in-relapsed-or-refractory-pediatric-cbf-aml-with-kit-mutation-100540447",false,"NCT06316960","Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation","A Prospective, Multicenter Clinical Study on The Safety and Efficacy of Avapritinib in The Treatment of Relapsed\u002FRefractory Pediatric Core Binding Factor Acute Myeloid Leukemia (CBF-AML) With KIT Mutation","Inclusion Criteria:\n\n1. Gender unlimited;\n2. Under 18 years;\n3. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).\n4. Presence of t(8;21)\u002FRUNX1::RUNX1T1 or inv(16)\u002Ft(16;16)\u002FCBFβ::MYH11;\n5. KIT mutation;\n6. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;\n7. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;\n8. No active infections;\n9. Liver function: Tbil ≤2×ULN, ALT\u002FAST ≤3×ULN, creatinine clearance ≥50ml\u002Fmin;\n10. ECOG score \\\u003C2;\n11. Expected survival time \\>12 weeks;\n12. Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.\n\nExclusion Criteria:\n\n1. Have received prior treatment with avapritinib;\n2. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;\n3. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);\n4. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；\n5. With other malignancies requiring treatment；\n6. Already enrolled in another interventional clinical study；\n7. The researchers determined that the individual is not suitable to participate in this trial.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.",[26,27,28,29,30],"AML, Childhood","Relapse\u002FRecurrence","Refractory AML","Core Binding Factor Acute Myeloid Leukemia","C-KIT Mutation",[32,33,34,35,36],"Avapritinib","KIT","CBF AML","Childhood","Relapsed\u002FRefractory","RECRUITING","2024-08-21",{"date":40,"type":41},"2024-08-22","ACTUAL",{"date":43,"type":41},"2024-03-01",{"date":45,"type":20},"2027-03",{"name":47,"class":48},"Children's Hospital of Soochow University","OTHER",12,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100440025","phase-2-efficiency-of-imatinib-treatment-after-10-years-of-treatment-in-patients-with-gastrointestinal-stromal-tumours-gist-gist-ten-100440025","NCT05009927","Efficiency of Imatinib Treatment After 10 Years of Treatment in Patients With Gastrointestinal Stromal Tumours (GIST) (Gist-Ten)","Randomized, Multicentre, Phase II Study Evaluating the Interest of Imatinib Treatment Maintenance or Interruption After at Least 10 Years of Treatment in Patients With Locally Advanced\u002FMetastatic Gastrointestinal Stromal Tumors (GISTs)","Inclusion Criteria:\n\n* Patients ≥18 years of age;\n* Histologically documented diagnosis of malignant advanced\u002Fmetastatic GIST with immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases;\n* Eastern Cooperative Oncology Group (ECOG) - Performance status (PS) 0 to 2 evaluated within 7 days prior to the date of inclusion.\n* Patient must be under imatinib treatment (at 300 or 400mg\u002Fday) maintained for 10 years or over with no more than 12 months in total or 3 consecutive months of interruption during the treatment period;\n* Patient with controlled disease (without any progression under imatinib);\n* Willingness and ability to comply with scheduled visits, treatment plans , laboratory tests, and other study procedures;\n* Covered by a medical\u002Fhealth insurance;\n* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.\n\nExclusion Criteria:\n\n* Patient concurrently using other approved or investigational antineoplastic agents;\n* Patient with GIST harboring the mutation D842V in PDGFRA;\n* Major concurrent disease affecting cardiovascular system, liver, kidneys, haematopoietic system or else considered as clinically important by the investigator and that could be incompatible with patient's participation in this trial or would likely interfere with study procedures or results;\n* Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years;\n* Patient receiving concurrent treatment with warfarin (acceptable alternative: low-molecular weight heparin) or any prohibited concomitant and\u002For concurrent medications\n* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection;\n* Major surgery within 2 weeks prior to study entry.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Pregnant or breastfeeding woman\n* Patient requiring tutorship or curatorship or patient deprivied of liberty.",{"count":19,"type":20},[23],"This is a 2 arms study concerning patients under imatinib treatment for at least 10 years of treatment with locally advanced\u002Fmetastatic GIST.\n\nIn the first arm, patients will discontinue Imatinib treatment. This arm will allow to determine if the re-introduction of Imatinib at relapse is still an efficient treatment for the control of disease.\n\nIn the second arm, patients will continue Imatinib treatment, allowing to determine if the continuation of this treatment is efficient for disease control, by the rate of non-progression disease.",[61,30,62],"Metastatic Gastrointestinal Stromal Tumor (GIST)","Advanced Gastrointestinal Stromal Tumor (GIST)",[64,65,66,67,68,69,70],"Gastrointestinal Stromal Tumors (GIST)","Tyrosine kinase inhibitor","Maintenance therapy","Bayesian design","KIT +","Imatinib","Randomisation study","2023-08-31",{"date":73,"type":41},"2023-09-01",{"date":75,"type":41},"2022-01-03",{"date":77,"type":20},"2027-01",{"name":79,"class":48},"Centre Leon Berard",13]