[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575892":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral arsenic trixoide","EXPERIMENTAL","Patients will be treated in 28-day cycles.\n\nEach cycles will comprise:\n\nOral ATO (10mg\u002Fday or 0.15mg\u002Fkg\u002Fday in patients \\\u003C 50kg) from Days 1-14\n\nPLUS:\n\n* Oral ascorbic acid (1000mg\u002Fday) from Days 1-14\n* Azacitidine (75mg\u002Fm2\u002Fday s.c. or i.v.) from days 1-7; OR Decitabine (20mg\u002Fm2\u002Fday i.v.) from days 1-5; OR Oral-decitabine-cedazuridine (1 tablet\u002Fday) from days 1-5.\n* Venetoclax (100mg-400mg\u002Fday) from Days 1-14 (if used)",[13],"Drug: Oral arsenic trioxide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Oral arsenic trioxide","Patients will be treated in 28-day cycles.\n\nEach cycles will comprise:\n\nOral arsenic trixoide (10mg\u002Fday or 0.15mg\u002Fkg\u002Fday in patients \\\u003C 50kg) from Days 1-14\n\nPLUS:\n\n* Oral ascorbic acid (1000mg\u002Fday) from Days 1-14\n* Azacitidine (75mg\u002Fm2\u002Fday s.c. or i.v.) from days 1-7; OR Decitabine (20mg\u002Fm2\u002Fday i.v.) from days 1-5; OR Oral-decitabine-cedazuridine (1 tablet\u002Fday) from days 1-5.\n* Venetoclax (100mg-400mg\u002Fday) from Days 1-14 (if used)",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Harinder Gill, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+852 2255 5859","gillhsh@hku.hk",[31],{"facility":32,"status":33,"city":34,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Queen Mary Hospital, Hong Kong","RECRUITING","Hong Kong","HK",{"type":37,"coordinates":38},"Point",[39,40],114.17469,22.27832,{"lat":40,"lon":39},[43,44,46],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":45,"role":27,"phone":20,"phoneExt":20,"email":20},"Harinder Gill",{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100575892","phase-2-oral-ato-for-tp53-mutated-myeloid-malignancies-100575892",false,"NCT06778187","Oral-ATO for TP53-mutated Myeloid Malignancies","A Phase 2 Study of Oral Arsenic Trioxide (Arsenol ®)-Based Low-intensity Treatment for Previously Untreated or Relapsed\u002FRefractory TP53-mutated Myeloid Malignancies","Inclusion Criteria:\n\n1. Willing and able to provide informed consent\n2. Age ≥18 years\n3. Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3)\n4. Presence of TP53 mutation\n5. Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory)\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n7. Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine\u002Fdecitabine\u002Foral-decitabine-cedazuridine.\n\nExclusion Criteria:\n\nInclusion Criteria\n\n1. Willing and able to provide informed consent\n2. Age ≥18 years\n3. Diagnosis of acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS) or chronic myelonocytic leukaemia (CMML) by World Health Organization (WHO) 2022 criteria (1, 3)\n4. Presence of TP53 mutation\n5. Previously untreated patients for Cohort A (Treatment-naïve), or Patients failing 1 or more lines of prior treatment for Cohort B (Relapsed and Refractory)\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n7. Women of childbearing potential and fertile men must agree to use an approved method of contraception from Screening until 30 days after the last dose of oral arsenic trioxide, ascorbic acid, venetoclax and azacitidine\u002Fdecitabine\u002Foral-decitabine-cedazuridine.\n\nExclusion Criteria\n\n1. Use of an investigational agent within 14 days of study treatment (or at least 7 half-lives of that agent, whichever is longer), prior to the first dose of oral arsenic trioxide\n2. Known hypersensitivity to arsenic trioxide, ascorbic acid, venetoclax or azacitidine\u002Fdecitabine\u002Foral-decitabine-cedazuridine or their excipients.\n3. Uncontrolled, active infection\n4. Major surgery within 4 weeks of starting the study drug, or not recovered from side effects of surgery\n5. Any other serious medical conditions that could compromise study participation, in the opinion of the investigator\n6. Known HIV infection or known, active hepatitis B or hepatitis C infection\n7. Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)\n8. Known history of long QT syndrome (LQTS) or corrected QT interval by Fridericia formula (QTcF) ≥ 480 ms\n9. Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local laboratory parameters:\n\n   1. Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation or eGFR; using CKD-EPI) \\\u003C 40 mL\u002Fmin\n   2. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x the local upper limit of normal\n10. Pregnant or lactating females, or females planning to become pregnant at any time during the study\n11. Unwilling or unable to comply with the study protocol","ALL","18 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","This is an open-label, phase 2 study of oral arsenic trioxide (Arsenol ®) in combination with ascorbic acid and investigator choice of low-intensity therapy in patients with previously untreated or relapse\u002Frefractory TP53-mutated acute myeloid leukemia (AML), myelodysplastic neoplasm (MDS), chronic myelomonocytic leukemia (CMML).",[66,67,68,69,70],"Acute Myeloid Leukemia","Myelodysplastic Neoplasm","Chronic Myelomonocytic Leukemia","TP53 Gene Mutation","Arsenic Trioxide",[72,73,74,75,17],"Acute myeloid leukemia","Myelodysplastic neoplasm","Chronic myelomonocytic leukemia","TP53 mutation","2025-06-05",{"date":78,"type":79},"2025-06-10","ACTUAL",{"date":81,"type":79},"2025-02-07",{"date":83,"type":60},"2028-02",{"name":5,"class":6},1]