[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591580":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":58,"collaborators":60,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Instituto do Cancer do Estado de São Paulo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Proposed protocol","EXPERIMENTAL","Oral Arsenic + ATRA with low-dose daunorubicin for high-risk patients",[13],"Drug: Realgar-Indigo Naturalis Formulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Realgar-Indigo Naturalis Formulation","Oral Arsenic (Realgar-Indigo Naturalis Formulation) plus ATRA for low-intermediate risk APL pts, combined with daunorubicin for high-risk during induction",[9],[21],"Oral Arsenic",[23],{"name":24,"affiliation":25,"role":26},"Eduardo M Rego, MD PhD","Instituto do Cancer do Estado de Sao Paulo","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Elaine Uehara","CONTACT","55 38933535",null,"elaine.uuehara@hc.fm.usp.br",[35],{"facility":25,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","São Paulo","01246000","Brazil","BR",{"type":42,"coordinates":43},"Point",[44,45],-46.63611,-23.5475,{"lat":45,"lon":44},[48,52,55,57],{"name":49,"role":30,"phone":50,"phoneExt":32,"email":51},"Wellington Silva, MD PhD","55 11 38934144","wellington.fernandes@hc.fm.usp.br",{"name":53,"role":30,"phone":50,"phoneExt":32,"email":54},"Rodrigo Bonardi, MD","rodrigo.bonardi@hc.fm.usp.br",{"name":49,"role":56,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"name":53,"role":56,"phone":32,"phoneExt":32,"email":32},{"type":59,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[61],{"name":62,"class":6},"American Society of Hematology","100591580","phase-2-oral-arsenic-with-atra-for-newly-diagnosed-patients-with-acute-promyelocytic-leukemia-100591580",false,"NCT06982274","Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia","Combination of Oral Arsenic With ATRA and Minimal-Dose Chemotherapy for Newly Diagnosed Patients With Acute Promyelocytic Leukemia: a Study by the International Consortium on APL","IC-APL2020","Inclusion Criteria:\n\n* Informed consent\n* New diagnosis of APL by cytomorphology, confirmed for molecular analysis\n* Age ≥18 and ≤75 years\n* Serum total bilirubin ≤ 3.0 mg\u002Fdl (≤ 51 μmol\u002Fl)\n* Serum creatinine ≤ 3.0 mg\u002Fdl (≤ 260 μmol\u002Fl)\n* Women must meet at least one of the following criteria to be eligible for inclusion in the study: Postmenopausal (12 months of amenorrhea or 6 months of amenorrhea with serum FSH \\> 40 U\u002Fml); After undergoing hysterectomy or bilateral oophorectomy; Continuous and correct use of a contraceptive method with a Pearl Index \\\u003C1% (e.g., implants, oral contraceptives, intrauterine devices); Sexual abstinence; Vasectomy of sexual partner.\n\nExclusion Criteria:\n\n* High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician;\n* Age \\\u003C18 or \\>75 years\n* Other active malignancy at the time of study entry\n* Lack of diagnostic confirmation at the genetic level\n* Significant arrhythmias, ECG abnormalities, or neuropathy: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (\\\u003C50 beats per minute); QTc \\> 500 ms on ECG screening for both sexes; Right bundle branch block with left anterior hemiblock or bifascicular block\n* High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \\\u003C 50%)\n* Uncontrolled and potentially fatal infections\n* Severe uncontrolled pulmonary or cardiac disease\n* Severe hepatic or renal dysfunction\n* Known HIV and\u002For hepatitis C infection\n* Pregnant or breastfeeding women\n* Allergy to the study drug or excipients in the study medication\n* Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or the assessment of study outcomes\n* Use of other investigational drugs at the time of enrollment or within 30 days before study entry.","ALL","18 Years","75 Years",{"count":75,"type":76},115,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","It is a non-randomized, multicenter, prospective study, aiming to treat patients with newly diagnosed acute promyelocytic leukemia with a combination of oral arsenic and atra, with low dose chemotherapy for those with high-risk disease (white blood cell count above 10x10a9\u002FL). The primary objective is to assess the 2-year overall survival (OS) in these patients, comparing with the historical control group of patients treated with ATRA\u002Fchemotherapy according to the IC-APL 2006 protocol.",[82],"Acute Promyelocytic Leukemia (APL)",[84,85,86,87],"Acute promyelocytic leukemia","Oral arsenic","Survival","All trans-retinoic acid","2025-05-26",{"date":90,"type":91},"2025-05-30","ACTUAL",{"date":93,"type":91},"2023-10-20",{"date":95,"type":76},"2029-11",{"name":5,"class":6},1]