[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457783":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Tarapeutics Science Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HYML-122 plus cytarabine","EXPERIMENTAL","The first three eligible enrolled patients will be treated with initial dosing of HYML-122 400mg bid daily and cytarabine 100mg\u002Fm2 intravenously by using \"3+3\" escalating design to explore RP2D. the Data Monitoring Committee (DMC) will evaluate the safety, efficacy and PK data of the phase 1 subjects and establish the combined regimen recommended dose. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgement of the investigator, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet 1 of the discontinuation criteria, whichever occurs first.",[13],"Drug: HYML-122; cytarabine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","HYML-122; cytarabine","HYML-122 is administered orally consecutive with 400mg bid or 600mg bid or dose adjusted by DMC judgement in each 28-day treatment cycle. cytarabine is administered by intravenous infusion with 100mg\u002Fm2 or dose adjusted by DMC judgement once daily on the first to 7th day of each treatment cycle. Upon completion of each 28-day treatment cycle, patients may continue to receive HYML-122 and cytarabine if they are benefit from the treatment and the toxicity is tolerable.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Depei Wu, MD. PhD","The First Affiliated Hospital of Soochow University","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Yang Shu, MD. BS.","CONTACT","+8613918983465","shuyang@tarapeutics.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"the First Affiliated Hospital of Soochow University","RECRUITING","Suzhou","Jiangsu","215006","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.59538,31.30408,{"lat":45,"lon":44},[48],{"name":23,"role":29,"phone":49,"phoneExt":20,"email":50},"0086-0512-67781856","drwudepei@163.com",{"type":52,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100457783","phase-2-a-study-of-hyml-122-and-cytarabine-in-patients-with-flt3-positive-relapsed-or-refractory-acute-myeloid-leukemia-aml-100457783",false,"NCT05241093","A Study of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","A Single-arm, Open, Multicenter, Phase II Study to Investigator the Efficacy and Safety of HYML-122 and Cytarabine in Patients With FLT3 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol.\n* Males and\u002For females at least 18 years old when signing the informed consent form.\n* Histologically confirmed AML (defined using WHO criteria 2016) with one of the following: Refractory to at least 1 cycle of induction chemotherapy. Relapsed after achieving remission with a prior therapy.\n* Subject is positive for FLT3 mutation in bone marrow or blood after completion of the subject's last interventional treatment.\n* Eastern cooperative oncology group performance status (ECOG) ≤2 at screening.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose.\n\nExclusion Criteria:\n\n* Known or suspected allergies to any of the investigational drug composition (HYML-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol).\n* Medical history and surgical history excluded according to the protocol.\n* Any previous medical treatment history exclude from the protocol.\n* Abnormal laboratory results exclude from the protocol.\n* Combination of treatments and\u002For drugs required during the study period and cannot be discontinued that excluded from the protocol.\n* Alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g\u002Fd for men, ≥20g\u002Fd for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g\u002Fd. alcohol volume (g) conversion formula=alcohol consumption (mL)\\*alcohol content (%)\\*0.8.\n* Abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose.\n* History of drug abuse or drug addicts.\n* Subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.","ALL","18 Years",{"count":63,"type":64},18,"ESTIMATED","INTERVENTIONAL",[67],"PHASE2","This is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of HYLM-122 in combination with cytarabine in Chinese subjects with FLT3 positive relapsed or refractory acute myeloid leukemia.",[70],"Relapsed or Refractory Acute Myeloid Leukemia (AML)","2025-04-09",{"date":73,"type":74},"2025-04-10","ACTUAL",{"date":76,"type":74},"2022-03-29",{"date":78,"type":64},"2026-06-30",{"name":5,"class":6},1]