[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100389317":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":30,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":20,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"rasburicase","EXPERIMENTAL","rasburicase 0.20 mg\u002Fkg\u002Fday by intravenous (IV) over 30 minutes for 1 to 5 days according to the level of plasma uric acid or Investigator's clinical judgement",[13],"Drug: RASBURICASE SR29142",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","RASBURICASE SR29142","Pharmaceutical form:solution for infusion Route of administration: intravenous",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Clinical Sciences & Operations","STUDY_DIRECTOR",[26],{"facility":27,"status":20,"city":28,"state":20,"zip":20,"country":28,"countryCode":29,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"investigational site CHINA","China","CN",{"type":31,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100389317","phase-4-evaluate-the-efficacy-and-safety-of-rasburicase-fasturtec-in-the-prevention-and-treatment-of-hyperuricemia-in-pediatric-patients-with-non-hodgkins-lymphoma-and-acute-leukemia-100389317",false,"NCT04349306","Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin's Lymphoma and Acute Leukemia","An Open-label, Single-arm, Multi-center Study to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec) in the Prevention and Treatment of Hyperuricemia in Pediatric Patients With Non-Hodgkin¿s Lymphoma and Acute Leukemia","RAISE","Inclusion criteria :\n\n* Patient or parent\u002Flegal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent.\n* Children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent.\n* At screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (PS) no greater than 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS no less than 30 on the Lansky score as per the Investigator's preference (see Appendix D for ECOG and Lansky scale).\n* Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy,baseline blood uric acid greater than 8 mg\u002FdL (473 mol\u002FL) at screening.\n* If newly diagnosed NHL patient with blood uric acid no greater than 8 mg\u002FdL at screening, the patient must be diagnosed with Stage III or IV non-Hodgkin's lymphoma with high tumor burden which will be high risk of TLS defined, with one or more of following below: A. Burkitt lymphoma\u002Fleukemia or -lymphoblastic lymphoma, and\u002For B. Has at least one of lymph node or tumor, the diameter \\>5 cm, and\u002For C. Lactate dehydrogenase (LDH) no less than 2 times the upper limit of normal (ULN).\n* If newly diagnosed AL patient is with blood uric acid no greater than 8 mg\u002FdL at the screening but with a high risk of TLS defined with one of the following below criteria: A. White blood cell (WBC) no less than 100.0 10-9\u002FL, or B. WBC \\\u003C 100.0 10-9\u002FL with LDH no less than 2 ULN.\n* The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase.\n\nExclusion criteria:\n\n* Acute promyelocytic leukemia\n* Patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration.\n* Patients with abnormal liver or renal function: alanine aminotransferase (ALT) \\>5 ULN, total bilirubin \\>3 ULN, serum creatinine \\>3 ULN.\n* Documented history of hereditary allergy or asthma.\n* Patients with known deficiency of glucose-6-phosphate dehydrogenase (G6PD), or a history of hemolytic disease or methemoglobinemia.\n* Patients with severe infection or active bleeding.\n* Previous therapy with urate oxidase.\n* Hypersensitive reaction against rasburicase or any of the other ingredients of the study drug.\n* Patient is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.\n* Pregnant or breastfeeding woman.\n* Woman of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and\u002For who are unwilling or unable to be tested for pregnancy (see contraceptive guidance in Appendix A).\n* Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","2 Years","18 Years",{"count":44,"type":45},50,"ACTUAL","INTERVENTIONAL",[48],"PHASE4","Primary Objective:\n\nTo evaluate safety of rasburicase in pediatric patients with NHL and AL\n\nSecondary Objective:\n\nTo assess efficacy of rasburicase for prevention and treatment of hyperuricemia",[51],"Lymphoma","COMPLETED","2022-04-22",{"date":55,"type":45},"2022-04-25",{"date":57,"type":45},"2020-05-14",{"date":59,"type":45},"2021-03-12",{"name":5,"class":6},1]