[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-promyelocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-promyelocytic-leukemia":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,59,89,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100631728","phase-3-pivotal-open-label-phase-3-clinical-study-of-qtx-2101-in-adult-patients-with-acute-promyelocytic-leukemia-100631728",false,"NCT07504458","Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia","A Pivotal Open-label Phase 3 Clinical Study Evaluating the Efficacy and Safety of QTX-2101 in Combination With All-trans Retinoic Acid in Newly Diagnosed, Low-risk Acute Promyelocytic Leukemia","QUATRO-APL","Inclusion Criteria:\n\n1. Informed Consent\n2. Participants must be between 18 and under 71 years of age\n3. Participants must have a confirmed diagnosis of APL proven by standard genetic testing (t(15;17) or PML-RARA)\n4. Participants must be classified as low- or intermediate-risk APL\n5. Participants must be willing and able to comply with the scheduled study visits, treatment plans, laboratory tests, contraception guidance, and other procedures\n\nExclusion Criteria\n\n1. Participants who have significant heart rhythm problems including long QT syndrome, serious arrhythmias, very slow heart rate, or prolonged QTc on ECG\n2. Participants who have central nervous system leukemia\n3. Participants having serious ongoing medical conditions or infections including uncontrolled infections, severe organ disease, or conditions that make study participation unsafe\n4. Participants who are pregnant, breastfeeding, or unwilling to use contraception\n5. Participants who are unable to safely take study medication, including severe neuropathy, inability to swallow oral medication, malabsorption issues, or known allergy to ATO or ATRA","ALL","18 Years","71 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This Phase 3 study in adult participants with newly diagnosed low-risk APL will evaluate the efficacy, safety, and PK of an oral capsule formulation of ATO, in combination with ATRA.",[28,29,30,31,32],"Acute Promyelocytic Leukemia (APL)","Acute Promyelocytic Leukaemia","Acute Promyelocytic Leukemia With PML-RARA","Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA","Acute Promyelocytic Leukemia",[34,32,35,36,37,38,39,40,41,42,43,44,45],"APL","Hematology","Oncology","Leukemia","Hematologic Disease","Drug Therapy","Therapeutics","Blood Cancer","Heme Malignancy","Arsenic","low-risk APL","standard-risk APL","RECRUITING","2026-06-13",{"date":49,"type":50},"2026-06-16","ACTUAL",{"date":52,"type":50},"2026-06-08",{"date":54,"type":22},"2030-12",{"name":56,"class":57},"Quetzal Therapeutics","INDUSTRY",7,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100615733","phase-3-a-trial-to-investigate-whether-oral-arsenic-trioxide-is-similar-to-intravenous-arsenic-trioxide-in-pharmacokinetics-safety-and-efficacy-latitudesdkars-301-100615733","NCT07296445","A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE\u002FSDKARS-301)","LATITUDE - A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2-Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High-Risk, Acute Promyelocytic Leukemia","LATITUDE","Key Inclusion Criteria:\n\n* Participants must have diagnosis of newly diagnosed non-high risk APL with a WBC count at diagnosis ≤ 10,000 cells\u002FµL, completed induction with ATO\u002FATRA and achieved morphologic CR with hematologic recovery\n* Eastern Cooperative Oncology Group performance status ≤2\n* Adequate liver, kidney, and cardiac function\n* Have a life expectancy of at least 9 months\n* Negative serum pregnancy test\n\nKey Exclusion Criteria:\n\n* Diagnosis of relapsed or refractory APL.\n* Fridericia's corrected QT interval (QTcF) \\>450 milliseconds (males) and \\>460 milliseconds (females)\n* Any gastrointestinal (GI) issue likely to affect oral drug absorption\u002Fmetabolism or inability to swallow oral medication\n* Prior malignancy or currently receiving treatment for a non-APL malignancy, with the following exceptions: basal cell or squamous cell skin cancer treated with surgical resection, in situ cervical cancer, localized prostate cancer or breast cancer treated with hormone therapy or surgical resection, or other cancer from which the participant has been disease free for at least 2 years.\n* Pregnant or nursing females or is of reproductive potential and unwilling to comply with contraceptive requirements.\n* Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.\n\nNote: Additional inclusion\u002Fexclusion criteria may apply, per protocol.","12 Years",{"count":69,"type":22},120,[25],"LATITUDE: A Phase 3, Randomized, Open-Label, 3-Cohort, 2-Period, 2- Sequence, Crossover Trial to Evaluate the Pharmacokinetics, Safety, and Efficacy of Oral Arsenic Trioxide Versus Intravenous Arsenic Trioxide for Consolidation Therapy in Participants With Newly Diagnosed, Non-High Risk, Acute Promyelocytic Leukemia\n\nRationale:\n\nSDK Therapeutics is developing an oral formulation of arsenic trioxide (ATO) for the treatment of acute promyelocytic leukemia (APL). Patients with APL are usually treated with arsenic trioxide (ATO) through an IV along with all-trans retinoic acid (ATRA) taken by mouth. Receiving ATO through an IV requires patients with APL to go to the hospital a lot and get long treatments (sometimes every day over a year of treatment). This can be hard and uncomfortable. If ATO can be taken by mouth, it would be much easier for patients and their families.\n\nObjective:\n\nThe main objective is to show that the body absorbs the same amount of ATO whether it's taken by mouth or through an IV. Other objectives include checking if ATO taken by mouth works just as well, causes fewer heart problems, is safe, and improves quality of life compared with ATO given through an IV.\n\nMain trial endpoints:\n\nThe main endpoint being measured is how much ATO is in the blood after 5 doses. Another important endpoint is how many patients have no signs of cancer in their blood after 3 rounds of treatment.\n\nSecondary trial endpoints:\n\nOther things being measured include: whether patients stay cancer-free over 2 years; changes in heart rhythm; side effects and lab test results; how patients feel during treatment; how much of ATO is in the blood; and how often patients feel bothered by side effects.\n\nTrial design:\n\nThis is an open-label study, meaning everyone knows which treatment they are getting. Patients will get 4 rounds of treatment, each lasting 8 weeks. After that, patients will have check-ups every 3 months to assess safety and disease status for a total of 2 years.\n\nTrial population:\n\nThe study includes adults and teens (12 years and older) who have APL, are not high-risk, and have already finished the first part of their treatment (induction) with IV ATO and ATRA.\n\nInterventions:\n\nThere are 3 groups in the study:\n\nCohort A: Takes 0.15 mg\u002Fkg Oral ATO for 3 rounds, then switches to 0.15 mg\u002Fkg IV ATO for part of the 4th round.\n\nCohort B: Takes 0.15 mg\u002Fkg IV ATO for 3 rounds, then switches to 0.15 mg\u002Fkg Oral ATO for part of the 4th round.\n\nCohort C: Takes 0.15 mg\u002Fkg Oral ATO for all 4 rounds.\n\nAll cohorts also take 45 mg\u002Fm2\u002Fday ATRA during certain weeks of each round. Doctors will assess efficacy by checking bone marrow samples before and during treatment to see if the cancer is gone. Special lab tests will be used to look for cancer cells. Safety will be assessed by checking for side effects using blood tests, heart tests, physical exams, and other health checks. Quality of life will be assessed by the patients who will fill out surveys about how they feel during treatment and how much the side effects bother them. The study will also look at how often patients need to go to the doctor or hospital; how treatment affects daily life and work; and how satisfied patients are with their treatment.",[28,29,30,31,34,32,73,74,75],"Leukaemia","Leukemia Acute Promyelocytic Leukemia (APL)","Leukemia, Acute",[77,78],"Oral Arsenic Trioxide","Oral ATO","NOT_YET_RECRUITING","2025-12-25",{"date":82,"type":50},"2025-12-29",{"date":84,"type":22},"2026-01",{"date":86,"type":22},"2029-01",{"name":88,"class":57},"SDK Therapeutics, Inc.",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100415249","phase-2-frontline-oral-arsenic-trioxide-for-apl-100415249","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",{"count":97,"type":22},100,[99],"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.",[32],[32,77,103],"Chemotherapy-free","2025-06-09",{"date":106,"type":50},"2025-06-12",{"date":108,"type":50},"2021-01-01",{"date":110,"type":22},"2026-06-30",{"name":112,"class":113},"The University of Hong Kong","OTHER",2,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100423443","phase-2-treatment-study-for-children-and-adolescents-with-acute-promyelocytic-leukemia-100423443","NCT04793919","Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia","Inclusion Criteria:\n\n* Newly diagnosed APL confirmed by the presence of PML\u002FRARα fusion gene\n* Age \\\u003C18 years\n* Written informed consent by parents or legal guardians\n\nExclusion Criteria:\n\n* Patients with a clinical diagnosis of APL but subsequently found to lack PML\u002FRARα rearrangement should be withdrawn from the study and treated on an alternative protocol\n* Significant liver dysfunction (bilirubin serum levels \\>3 mg\u002FdL, ALT\u002FAST serum levels greater than 5 times the normal values)\n* Creatinine serum levels \\>2 times the normal value for age\n* Significant arrhythmias, EKG abnormalities (\\*see below), other cardiac contraindications (L-FEV \\\u003C50% or LV-FS \\\u003C28%)\n* Neuropathy\n* Concurrent active malignancy\n* Uncontrolled life-threatening infections\n* Pregnant or lactating female\n* Patients who had received alternative therapy (APL not initially suspected; ATRA and\u002For ATO not available",{"count":122,"type":22},89,[99],"The trial is open to all patients with a diagnosis of acute promyelocytic leukemia (APL) who are PCR-positive for the PML-RARα transcript and less than 18 years of age.",[32],"2024-04-12",{"date":128,"type":50},"2024-04-15",{"date":130,"type":50},"2019-10-09",{"date":132,"type":22},"2027-10-10",{"name":134,"class":113},"Associazione Italiana Ematologia Oncologia Pediatrica",31]