[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arsenic-trioxide\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arsenic-trioxide":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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).",[26,27,28,29,30],"Acute Myeloid Leukemia","Myelodysplastic Neoplasm","Chronic Myelomonocytic Leukemia","TP53 Gene Mutation","Arsenic Trioxide",[32,33,34,35,36],"Acute myeloid leukemia","Myelodysplastic neoplasm","Chronic myelomonocytic leukemia","TP53 mutation","Oral arsenic trioxide","RECRUITING","2025-06-05",{"date":40,"type":41},"2025-06-10","ACTUAL",{"date":43,"type":41},"2025-02-07",{"date":45,"type":20},"2028-02",{"name":47,"class":48},"The University of Hong Kong","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":49},"100491669","phase-4-south-china-children-cancer-group---relapsed-acute-lymphoblastic-leukemia-2022-protocol-100491669","NCT05682131","South China Children Cancer Group - Relapsed-Acute Lymphoblastic Leukemia 2022 Protocol","SCCCG-R-ALL","Inclusion Criteria:\n\n* B or T cell type;\n* the first recurrence;\n* the risk stratification was medium or high risk.\n\nExclusion Criteria:\n\n* mature B cell leukemia;\n* acute mixed phenotype leukemia;\n* patients with positive BCR\u002FABL fusion gene;\n* the second tumor\n* definite CML blast crisis;\n* ALL with Down's syndrome.","1 Year","14 Years",{"count":60,"type":20},210,[62],"PHASE4","In recent years, the prognosis of pediatric relapsed ALL patients has improved, but the 5-year OS of patients with first recurrence is still less than 50%. A number of in vitro studies have shown that arsenic trioxide (ATO) can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ATO as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed ALL. Realgar Indigo naturalis formula is a compound traditional Chinese medicine preparation developed in China. The main component of realgar is arsenic tetrasulfide (As4S4), which can produce similar pharmacological effects to ATO. Based on the R3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound Huangdai tablets with compound Huangdai tablets in the treatment of intermediate and high risk ALL children, in order to improve the MRD negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed ALL.",[30,65],"Childhood ALL","2023-01-10",{"date":68,"type":41},"2023-01-12",{"date":70,"type":41},"2022-09-27",{"date":72,"type":20},"2030-09-27",{"name":74,"class":48},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]