[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"apl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:apl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,78],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},224,"ESTIMATED","INTERVENTIONAL",[25],"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",[28],"APL","RECRUITING","2026-03-26",{"date":32,"type":33},"2026-03-31","ACTUAL",{"date":35,"type":33},"2025-06-01",{"date":37,"type":22},"2028-06",{"name":39,"class":40},"First Affiliated Hospital Xi'an Jiaotong University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"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":52,"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.",[56,57,58,59,28,60,61,62,63],"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","Leukaemia","Leukemia Acute Promyelocytic Leukemia (APL)","Leukemia, Acute",[65,66],"Oral Arsenic Trioxide","Oral ATO","NOT_YET_RECRUITING","2025-12-25",{"date":70,"type":33},"2025-12-29",{"date":72,"type":22},"2026-01",{"date":74,"type":22},"2029-01",{"name":76,"class":77},"SDK Therapeutics, Inc.","INDUSTRY",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100506967","phase-2-treatment-of-chidamide-and-venetoclax-for-retinoic-acid-and-arsenic-resistant-acute-promyelocytic-leukemia-100506967","NCT05881265","Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia","Multi-center Phase II Prospective Study for the Treatment of Chidamide and Venetoclax in Patients With All-trans Retinoic Acid (ATRA) and Arsenic (As) Resistant Acute Promyelocytic Leukemia (APL)","Inclusion Criteria:\n\n* Patients with PML-RARα+ APL\n* Patients in non-remission status after treatment of RA combined with As\n* Patients with life expectance \\>=3 months\n* Inform consent provided\n\nExclusion Criteria:\n\n* Patients with incontrollable infection\n* Patients with life-expectancy less than 2 months\n* Patients with abnormal liver (\\>3XN) and renal function (\\>3XN）","16 Years","70 Years",{"count":88,"type":22},30,[90],"PHASE2","Based on the current treatment with retinoic acid (ATRA) and arsenic (As), most patients with APL achieved long-term survival. There are few patients relapsed and became refractory to the RA and As treatment. In our pre-clinical study, we found that targeting histone deacetylase inhibitor 3 (HDAC3)degraded PML-RARa oncoprotein and induced differentiation and apoptosis of RA and As resistant APL in vitro and in vivo. In this study, we evaluate the efficacy and feasibility of combination therapy for HDAC3 inhibitor and venetoclax in patients with refractory APL.",[28],[94],"refractory，APL","2025-02-14",{"date":97,"type":33},"2025-02-18",{"date":99,"type":33},"2023-05-15",{"date":101,"type":22},"2026-01-01",{"name":103,"class":40},"Shanghai Jiao Tong University School of Medicine",5]