protocolSection identificationModule nctId: NCT06316960, orgStudyIdInfo id: AVACBFKIT, briefTitle: Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: AML, Childhood, conditions: Relapse/Recurrence, conditions: Refractory AML, conditions: Core Binding Factor Acute Myeloid Leukemia, conditions: C-KIT Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Avapritinib, interventions name: Azacitidine Injection, interventions name: Decitabine Injection, interventions name: Idarubicin Hydrochloride, interventions name: Cytarabine, interventions name: Granulocyte Colony-Stimulating Factor, outcomesModule primaryOutcomes measure: Composite remission rate (CRc), secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital Of University of Science and Technology of China, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Chun Li, MD,PhD, role: CONTACT, phone: +86-13865992676, email: lichun1230@sohu.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The Second Hospital of Anhui Medical University, status: NOT_YET_RECRUITING, city: Hefei, state: Anhui, zip: 230000, country: China, contacts name: Ninglin Wang, MD, role: CONTACT, phone: +86-13721113063, email: zwnltt@126.com, geoPoint lat: 31.86389, lon: 117.28083, locations facility: Guangzhou Women and Children Medical Center, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Hua Jiang, MD, PhD, role: CONTACT, phone: +86-13533330985, email: jiang_hua18@sina.cn, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangxi Medical University, status: NOT_YET_RECRUITING, city: Nanning, state: Guangxi, zip: 530000, country: China, contacts name: Ning Liao, MD, role: CONTACT, phone: +86-13978812808, email: ln12808@163.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: Kaifeng Children's Hospital, status: NOT_YET_RECRUITING, city: Kaifeng, state: Henan, zip: 475000, country: China, contacts name: Jixia Luo, MD, role: CONTACT, phone: +86-13592146539, email: luojixia@163.com, geoPoint lat: 34.7986, lon: 114.30742, locations facility: The First Affiliated Hospital of Zhengzhou University, status: NOT_YET_RECRUITING, city: Zhengzhou, state: Henan, zip: 450052, country: China, contacts name: Yufeng Liu, MD,PhD, role: CONTACT, phone: +86-13673666608, email: lyf6012@126.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Third Xiangya Hospital of Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410000, country: China, contacts name: Minghua Yang, MD, role: CONTACT, phone: +86-13973135843, email: yamahua123@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: XiangYa Hospital Central South University, status: NOT_YET_RECRUITING, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Liangchun Yang, MD,PhD, role: CONTACT, phone: +86-13974927514, email: yangliangchung@163.com, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Children's Hospital of Soochow University, status: RECRUITING, city: Suzhou, state: Jiangsu, zip: 215000, country: China, contacts name: Shaoyan Hu, MD, PhD, role: CONTACT, phone: +86-13771835430, email: hsy139@126.com, contacts name: Li Gao, MD, role: CONTACT, phone: +86-15821963190, email: joygaoli@163.com, contacts name: Shaoyan Hu, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Peifang Xiao, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Li Gao, MD, role: SUB_INVESTIGATOR, contacts name: Jun Lu, MD, role: SUB_INVESTIGATOR, contacts name: Jie Li, MD, role: SUB_INVESTIGATOR, geoPoint lat: 31.30408, lon: 120.59538, locations facility: Xuzhou Children's Hospital, status: NOT_YET_RECRUITING, city: Xuzhou, state: Jiangsu, zip: 221000, country: China, contacts name: Qi An, MD, role: CONTACT, phone: +86-13814422329, email: anqi1974@sina.com, geoPoint lat: 34.18045, lon: 117.15707, locations facility: Qilu Hospital of Shandong University, status: NOT_YET_RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: Xiuli Ju, MD,PhD, role: CONTACT, phone: +86-13869192944, email: shellysdcn@hotmail.com, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Children's Hospital Of Fudan University, status: NOT_YET_RECRUITING, city: Shanghai, state: Shanghai, zip: 200000, country: China, contacts name: Xiaowen Zhai, MD, PhD, role: CONTACT, phone: +86-18017590808, email: zhaixiaowendy@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False