[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100164100":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":85,"centralContacts":89,"locations":94,"responsibleParty":157,"collaborators":159,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":46,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":46,"enrollmentInfo":172,"targetDuration":46,"studyType":175,"phases":176,"briefSummary":178,"conditions":179,"keywords":46,"overallStatus":97,"whyStopped":46,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":190},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (tretinoin, arsenic trioxide, gemtuzumab ozogamicin)","EXPERIMENTAL","INDUCTION: Patients receive tretinoin PO BID, arsenic trioxide IV over 1-2 hours daily, and gemtuzumab ozogamicin IV over 2 hours once at weeks 1-4.\n\nCONSOLIDATION: Patients achieving CR receive arsenic trioxide IV 5 days per week during weeks 1-4, 9-12, 17-20, and 25-28 and tretinoin PO BID for 2 weeks on and 2 weeks off. Treatment repeats every 8 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.",[13,14,15,16],"Drug: Arsenic Trioxide","Drug: Gemtuzumab Ozogamicin","Other: Laboratory Biomarker Analysis","Drug: Tretinoin",[18,31,42,47],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Arsenic Trioxide","Given IV",[9],[24,25,26,27,28,29,30],"Arsenic (III) Oxide","Arsenic Sesquioxide","Arsenous Acid","Arsenous Acid Anhydride","Arsenous Oxide","Trisenox","White Arsenic",{"type":19,"name":32,"description":21,"armGroupLabels":33,"otherNames":34},"Gemtuzumab Ozogamicin",[9],[35,36,37,38,39,40,41],"Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody","CDP-771","CMA-676","gemtuzumab","hP67.6-Calicheamicin","Mylotarg","WAY-CMA-676",{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Laboratory Biomarker Analysis","Correlative studies",[9],null,{"type":19,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Tretinoin","Given PO",[9],[52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84],"2,4,6,8-Nonatetraenoic acid, 3, 7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-, (all-E)-","Aberel","Airol","Aknoten","all trans-Retinoic acid","All-trans Retinoic Acid","All-trans Vitamin A Acid","all-trans-Retinoic acid","all-trans-Vitamin A acid","ATRA","Avita","beta-Retinoic Acid","Cordes Vas","Dermairol","Epi-Aberel","Eudyna","Renova","Retin-A","Retin-A MICRO","Retin-A-Micro","retinoic acid","Retisol-A","Ro 5488","Stieva-A","Stieva-A Forte","Trans Retinoic Acid","Trans Vitamin A Acid","trans-Retinoic acid","Tretinoinum","Vesanoid","vitamin A acid","Vitamin A acid, all-trans-","Vitinoin",[86],{"name":87,"affiliation":5,"role":88},"Farhad Ravandi-Kashani","PRINCIPAL_INVESTIGATOR",[90],{"name":87,"role":91,"phone":92,"phoneExt":46,"email":93},"CONTACT","713-745-0394","fravandi@mdanderson.org",[95,112,121,133,145],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-95.36327,29.76328,{"lat":107,"lon":106},[110,111],{"name":87,"role":91,"phone":92,"phoneExt":46,"email":46},{"name":87,"role":88,"phone":46,"phoneExt":46,"email":46},{"facility":113,"status":97,"city":98,"state":99,"zip":114,"country":101,"countryCode":102,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"MD Anderson Regional Care Center-Katy","77094",{"type":104,"coordinates":116},[106,107],{"lat":107,"lon":106},[119,120],{"name":87,"role":91,"phone":92,"phoneExt":46,"email":46},{"name":87,"role":88,"phone":46,"phoneExt":46,"email":46},{"facility":122,"status":97,"city":123,"state":99,"zip":124,"country":101,"countryCode":102,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"MD Anderson Regional Care Center-Bay Area","Nassau Bay","77058",{"type":104,"coordinates":126},[127,128],-95.09104,29.54468,{"lat":128,"lon":127},[131,132],{"name":87,"role":91,"phone":92,"phoneExt":46,"email":46},{"name":87,"role":88,"phone":46,"phoneExt":46,"email":46},{"facility":134,"status":97,"city":135,"state":99,"zip":136,"country":101,"countryCode":102,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"MD Anderson Regional Care Center-Sugar Land","Sugar Land","77478",{"type":104,"coordinates":138},[139,140],-95.63495,29.61968,{"lat":140,"lon":139},[143,144],{"name":87,"role":91,"phone":92,"phoneExt":46,"email":46},{"name":87,"role":88,"phone":46,"phoneExt":46,"email":46},{"facility":146,"status":97,"city":147,"state":99,"zip":148,"country":101,"countryCode":102,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"MD Anderson Regional Care Center-The Woodlands","The Woodlands","77384",{"type":104,"coordinates":150},[151,152],-95.48938,30.15799,{"lat":152,"lon":151},[155,156],{"name":87,"role":91,"phone":92,"phoneExt":46,"email":46},{"name":87,"role":88,"phone":46,"phoneExt":46,"email":46},{"type":158,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR",[160],{"name":161,"class":162},"National Cancer Institute (NCI)","NIH","100164100","phase-2-tretinoin-and-arsenic-trioxide-with-or-without-gemtuzumab-ozogamicin-in-treating-patients-with-previously-untreated-acute-promyelocytic-leukemia-100164100",false,"NCT01409161","Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia","Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)","Inclusion Criteria:\n\n* A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test\n* Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study\n* Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and\u002For one dose of idarubicin due to the urgency to start therapy early)\n* Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug\n* All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds\n* Patients with creatinine \\> 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease\n* Patients with total bilirubin \\>= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease\n* Patients with alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\> 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease","ALL","10 Years",{"count":173,"type":174},151,"ESTIMATED","INTERVENTIONAL",[177],"PHASE2","This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.",[180],"Acute Promyelocytic Leukemia With PML-RARA","2026-05-18",{"date":183,"type":184},"2026-05-20","ACTUAL",{"date":186,"type":184},"2011-10-05",{"date":188,"type":174},"2027-12-18",{"name":5,"class":6},5]