[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415249":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":32,"responsibleParty":64,"collaborators":30,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":30,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":30,"maxAge":30,"enrollmentInfo":74,"targetDuration":30,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":34,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA)","EXPERIMENTAL","Induction: Oral arsenic trioxide 10mg daily (0.16mg\u002Fkg\u002Fday in patients \\\u003C 18 years-old, all-trans retinoic acid (ATRA) \\[45mg\u002Fm\\^2 (25mg\u002Fm\\^2 per day in patients \\\u003C 18 years-old) in 2 divided doses) and ascorbic acid 1g daily (15mg\u002Fkg\u002Fday in patients \\\u003C 18 years-old) for 42 days Consolidation: Oral arsenic trioxide daily, ATRA, and ascorbic acid daily for 14 days every 28 days for 2 cycles.\n\nMaintenance: Oral arsenic trioxide, ATRA and ascorbic acid daily for 2 weeks every 8 weeks for a total of 2 years (i.e. for 12 cycles in total).",[13],"Drug: Oral Arsenic Trioxide Formulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Oral Arsenic Trioxide Formulation","Patients will be recruited to oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA) based-induction for 42 days. Daunorubicin or idarubicin will only be used during induction in patients \\\u003C65 with presenting white blood cell count (WBC) ≥ 10 x 10\\^9\u002FL. In patients not receiving daunorubicin, hydroxyurea if WBC ≥ 5 x 10\\^9\u002FL within the first 14 days of induction. A reassessment bone marrow aspirate will be performed on day 28 of induction for assessment of morphologic remission.\n\nFour weeks after the completion of induction phase, all patients, regardless of initial WBC, will receive two cycles of chemotherapy-free AAA consolidation (14 days every 28 days).\n\nFour weeks after completion of consolidation, all patients will receive 12 cycles of chemotherapy-free AAA maintenance (14 days every 8 week).",[9],[21],"ARSENOL",[23],{"name":24,"affiliation":5,"role":25},"Harry Gill, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+852 22554542",null,"gillhsh@hku.hk",[33,49],{"facility":5,"status":34,"city":35,"state":30,"zip":30,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Hong Kong","HK",{"type":38,"coordinates":39},"Point",[40,41],114.17469,22.27832,{"lat":41,"lon":40},[44,46],{"name":24,"role":28,"phone":45,"phoneExt":30,"email":31},"85222554542",{"name":47,"role":48,"phone":30,"phoneExt":30,"email":30},"Yok-Lam Kwong, MD","SUB_INVESTIGATOR",{"facility":50,"status":34,"city":51,"state":30,"zip":30,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"National University Hospital Singapore","Singapore","SG",{"type":38,"coordinates":54},[55,56],103.85007,1.28967,{"lat":56,"lon":55},[59,62],{"name":60,"role":28,"phone":30,"phoneExt":30,"email":61},"Melissa Ooi, MD","melissa_ooi@nuhs.edu.sg",{"name":63,"role":25,"phone":30,"phoneExt":30,"email":30},"Melissa Ooi",{"type":65,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100415249","phase-2-frontline-oral-arsenic-trioxide-for-apl-100415249",false,"NCT04687176","Frontline Oral Arsenic Trioxide for APL","Frontline Oral Arsenic Trioxide-based Induction in Newly Diagnosed Acute Promyelocytic Leukaemia","Inclusion Criteria:\n\n1. Newly diagnosed APL with t(15;17)(q24;q21) or acute myeloid leukaemia (AML) with variant RARA translocation according to the World Health Organization (WHO) Classification 2022\n2. Ability and willingness to comply with the study procedures and restrictions\n3. Voluntary written informed consent\n\nExclusion Criteria:\n\n1. ECOG performance score \\>2\n2. Decompensated heart failure with left-ventricular ejection fraction of less than 40% and global hypokinesia on echocardiogram.\n3. Prolonged corrected QT interval (QTc) ≥ 500ms, in the absence of electrolyte disturbances and medications known to prolong QTc\n4. Significant liver function derangement (Bilirubin \\> 3 times upper limit normal and\u002For ALT \\> 5 times upper limit of normal)\n5. Glomerular filtration rate (GRF) by Cockcroft-Gault formula or eGFR (MDRD) of less than 30mL\u002Fmin in adults (aged ≥ 18) or Creatinine clearance \\\u003C 50ml\u002Fmin\u002F1.73m2 in paediatric and adolescent patients (Age ≤ 17)\n6. Female subject who is lactating or has positive pregnancy test result prior to the first dose of study drug","ALL",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","The investigators have formulated an oral preparation of arsenic trioxide (oral-ATO), and shown that it is efficacious for APL in R1, inducing CR2 in more than 90% of patients \\[8,9\\]. Furthermore, in an effort to prevent relapse, the investigators have moved oral-ATO forward to the maintenance of CR1. This strategy results in favorable overall-survival (OS) and leukemia-free-survival (LFS) \\[10\\], implying that prolonged treatment with oral-ATO may prevent relapses.\n\nCurrent protocols have incorporated i.v.-ATO in the treatment of newly-diagnosed APL \\[11-15\\]. For regimens comprising oral-ATO, ATRA and chemotherapy, 5-year OS in excess of 90% is achieved \\[11-15\\].\n\nThe investigators have also published long-term data showing the use of oral-ATO is highly effective and safe in the relapsed and frontline settings \\[16,17\\].\n\nIn this study, the investigators evaluate the use of oral-ATO and ATRA based induction regimens in newly diagnosed patients with APL with no of minimal chemotherapy in a prospective multicentre phase 2 study.",[82],"Acute Promyelocytic Leukemia",[82,84,85],"Oral Arsenic Trioxide","Chemotherapy-free","2025-06-09",{"date":88,"type":89},"2025-06-12","ACTUAL",{"date":91,"type":89},"2021-01-01",{"date":93,"type":76},"2026-06-30",{"name":5,"class":6},2]