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Box 256, SE-751 05","Sweden",{"type":59,"coordinates":442},[443,444],17.63889,59.85882,{"lat":444,"lon":443},[447],{"name":448,"role":47,"phone":49,"phoneExt":49,"email":449},"Josefine Palle, MD","josefine.palle@akademiska.se",{"type":451,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100423443",false,"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Patients with a clinical diagnosis of APL but subsequently found to lack PML\u002FRARα rearrangement should be withdrawn from the study and treated on an alternative protocol\n* Significant liver dysfunction (bilirubin serum levels \\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","ALL","18 Years",{"count":460,"type":461},89,"ESTIMATED","INTERVENTIONAL",[464],"PHASE2","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.",[467],"Acute Promyelocytic Leukemia","2024-04-12",{"date":470,"type":471},"2024-04-15","ACTUAL",{"date":473,"type":471},"2019-10-09",{"date":475,"type":461},"2027-10-10",{"name":5,"class":6},31]