[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631672":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":26,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ATRA","SHAM_COMPARATOR","ATRA without RIF in first week of induction phase",[13,14],"Drug: ATRA","Drug: ATO",{"label":16,"type":17,"description":18,"interventionNames":19},"ATRA+RIF","EXPERIMENTAL","ATRA with RIF in first week of induction phase",[13,20,14],"Drug: RIF",[22,27,31],{"type":23,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","All-trans retinoic acid, oral, for 4 weeks (Days 0-28).",[9,16],null,{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"RIF","Realgar-Indigo Naturalis Formula, oral, for 1 week (Days 0-7).",[16],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"ATO","Sham Comparator:Arsenic trioxide for 4 weeks (Days 0-28). Experimental:Arsenic trioxide for 3 weeks (Days 8-28).",[9,16],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Huaiyu Wang","CONTACT","+8618991232410","whymed@126.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"First Affiliated Hospital of Xi'an Jiaotong University","RECRUITING","Xi'an","Shaanxi","710061","China","CN",{"type":51,"coordinates":52},"Point",[53,54],108.92861,34.25833,{"lat":54,"lon":53},{"type":57,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100631672","phase-3-early-use-of-realgar-indigo-naturalis-formula-rif-combined-with-all-trans-retinoic-acid-atra-for-treating-acute-promyelocytic-leukemia-apl-100631672",false,"NCT07503730","Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL).","Multicenter, Randomized Controlled Clinical Study on Early Application of Realgar-Indigo Naturalis Formula (RIF) for Treatment of Acute Promyelocytic Leukemia (APL)","EARLY-RIF APL","Inclusion Criteria:\n\n1. Age between 18 and 80 years.\n2. Diagnosed with acute myeloid leukemia confirmed by bone marrow morphology and immunophenotyping, with a high clinical suspicion of acute promyelocytic leukemia (APL).\n\nExclusion Criteria:\n\n1. Confirmed non-APL (M3 type) acute myeloid leukemia through cytogenetic and RT-PCR testing (PML-RARα fusion gene negative).\n2. Severe liver or kidney dysfunction unrelated to APL (e.g., serum creatinine \\> 2.5 times the upper limit of normal, total bilirubin ≥ 2 times the upper limit, ALT and AST \\> 3 times the upper limit), or heart failure (e.g., EF \\\u003C 40%).\n3. Presence of other malignancies.\n4. Pregnant or breastfeeding women.","ALL","18 Years","80 Years",{"count":70,"type":71},224,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","Study Title:\n\nMulticenter, Randomized Controlled Clinical Study on Early Application of Realgar-Indigo Naturalis Formula (RIF) for Treatment of Acute Promyelocytic Leukemia (APL)\n\nSponsor:\n\nXi'an Jiaotong University First Affiliated Hospital\n\nPrincipal Investigator:\n\nWang Huaiyu\n\nStudy Description:\n\nThis multicenter, randomized controlled trial evaluates whether early induction treatment with oral Realgar-Indigo Naturalis Formula (RIF) combined with all-trans retinoic acid (ATRA) reduces early death rates in patients with acute promyelocytic leukemia (APL). APL is a subtype of acute myeloid leukemia characterized by a high risk of early death, largely due to coagulopathy and bleeding events, especially in high-risk patients with elevated white blood cell counts.\n\nTraditional treatment with ATRA and arsenic trioxide (ATO) has improved outcomes but early mortality remains a major challenge. RIF, an oral arsenic compound Chinese patent medicine, has demonstrated efficacy comparable to ATO with advantages in safety and oral administration convenience. Previous smaller studies suggested RIF may accelerate recovery of coagulation parameters and reduce early death.\n\nPatients clinically suspected of APL will be randomized into two groups:\n\nExperimental group: oral ATRA + RIF before molecular diagnosis confirmation\n\nControl group: oral ATRA only before confirmation\n\nAfter molecular or genetic diagnosis confirmation:\n\nExperimental group receives 1 week of ATRA + RIF induction (days 0-7), then switches to 3 weeks ATRA + ATO (days 8-28)\n\nControl group receives 4 weeks ATRA + ATO (days 0-28)\n\nBoth groups then receive identical consolidation therapy with ATRA + ATO for 6 cycles (2 weeks treatment + 2 weeks off per cycle) following molecular complete remission.\n\nPrimary Objective:\n\nTo evaluate whether early induction with ATRA + RIF reduces early death rate (within 30 days of diagnosis) in APL patients.\n\nSecondary Objectives:\n\nTo explore if early ATRA + RIF (prior to molecular confirmation) is non-inferior to ATRA alone in reducing coagulopathy and early death in suspected APL patients. Secondary endpoints include 2-year event-free survival (EFS) and overall survival (OS).\n\nStudy Design:\n\nType: Multicenter, randomized, open-label controlled clinical trial\n\nPopulation: Adults aged 18-80 years with newly diagnosed acute myeloid leukemia highly suspected as APL\n\nRandomization: Central randomization assigns participants to experimental (ATRA + RIF) or control (ATRA only) groups\n\nBlinding: Open-label (no blinding)\n\nInclusion Criteria:\n\nAge 18-80\n\nNewly diagnosed AML with strong clinical suspicion of APL based on bone marrow morphology and immunophenotyping\n\nExclusion Criteria:\n\nNegative for PML-RARα fusion by cytogenetics or RT-PCR\n\nSevere organ dysfunction not related to APL (renal, hepatic, cardiac)\n\nQTc \\>480 ms before treatment\n\nOther malignancies\n\nPregnant or breastfeeding women\n\nTreatment Regimen:\n\nInduction: Experimental group receives oral ATRA 25 mg\u002Fm²\u002Fday + RIF 60 mg\u002Fkg\u002Fday for 7 days, then ATRA + intravenous ATO 0.15 mg\u002Fkg\u002Fday for 3 weeks; Control group receives ATRA + ATO for 4 weeks.\n\nConsolidation:During the consolidation phase, intermediate- and low-risk patients receive either intravenous ATO or oral RIF, while high-risk patients receive intravenous ATO together with intravenous mannitol infusion. Routine lumbar puncture and intrathecal chemotherapy are not performed.\n\nSupportive care includes hydroxyurea and venetoclax for elevated WBC, transfusions for coagulopathy, and dexamethasone for differentiation syndrome.\n\nEndpoints:\n\nPrimary endpoint: Early death rate (death within 30 days of diagnosis)\n\nSecondary endpoints: 2-year event-free survival (EFS), 2-year overall survival (OS)\n\nSample Size:\n\nApproximately 224 patients (112 per group), calculated to detect a reduction in early death rate from 12% (historical) to 3% (experimental), with 80% power and 5% significance level.\n\nStatistical Analysis:\n\nDescriptive statistics for baseline characteristics and adverse events\n\nKaplan-Meier survival analysis for EFS and OS\n\nSignificance threshold p \\\u003C 0.05\n\nSafety Monitoring:\n\nDaily blood count and coagulation tests during induction\n\nMonitoring and management of adverse events including severe coagulation disorders, differentiation syndrome, arsenic toxicity, infection, and bone marrow suppression\n\nAdverse events graded with CTCAE criteria and reported accordingly\n\nData Handling:\n\nElectronic data capture system compliant with ICH-GCP and CDISC standards\n\nConfidential storage at Xi'an Jiaotong University First Affiliated Hospital\n\nData anonymized for reporting\n\nEthics:\n\nConducted in accordance with the Declaration of Helsinki and Chinese clinical research regulations\n\nProtocol approved by local ethics committee\n\nWritten informed consent required before study enrollment\n\nStudy Timeline:\n\nPlanned start: June 2025\n\nPlanned completion: June 2028",[77],"APL","2026-03-26",{"date":80,"type":81},"2026-03-31","ACTUAL",{"date":83,"type":81},"2025-06-01",{"date":85,"type":71},"2028-06",{"name":5,"class":6},1]