[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554818":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":34,"collaborators":20,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":20,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":20,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":20,"overallStatus":56,"whyStopped":20,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"modified-DEP for HLH","EXPERIMENTAL","modified-DEP for the treatment of non-EBV-HLH and EBV-HLH patients.",[13],"Drug: modified-DEP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","modified-DEP","For non-EBV-HLH patients: Liposomes doxorubicin, 25 mg\u002Fm2 d1, etoposide 100 mg\u002Fm2 d1, methylprednisolone 1 mg\u002Fkg d1-3, then tapering according to patients condition, fully stop with d7 to d10; ruxolitinib, 15 mg bid. Emapalumab, if needed.\n\nFor EBV-HLH patients: PD-1 monoclonal antibody, 2 mg\u002Fkg (maximum dose, 200 mg) d-3, liposomes doxorubicin, 25 mg\u002Fm2 d1, etoposide 100 mg\u002Fm2 d1, methylprednisolone 1 mg\u002Fkg d1-3, then tapering according to patients condition, fully stop with d7 to d10; ruxolitinib, 15 mg bid. Emapalumab, if needed.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Xuefeng He, Dr","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","86-18914031640","hexuefeng@suda.edu.cn",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Yue Song, Dr","86-18810253070","xueqifeng1992@163.com",{"type":24,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Xuefeng He","Dr","100554818","phase-4-modified-dep-regimens-for-the-treatment-of-hemophagocytic-lymphohistiocytosis-100554818",false,"NCT06504030","Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis","A Single-arm, Single-center, Prospective Study of Modified DEP Regimens (Doxorubicin+ Etoposide + Methylprednisolone) for the Treatment of Hemophagocytic Lymphohistiocytosis","Inclusion Criteria:\n\n1. According to the HLH-2004 criteria, the patient meets the HLH diagnosis.\n2. 1 year old \\\u003C age \\\u003C 70 years old, regardless of gender.\n3. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times the normal value; fibrinogen can be corrected to ≥ 0.6g\u002FL after infusion.\n\n3\\. Serum HIV antibody negative; HCV antibody negative, or HCV antibody positive, but HCV-RNA negative. HBV surface antigen and HBV core antibody are both negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer detection is required, and it must be less than 1×103 copies\u002Fml before enrollment.\n\n4\\. Women of childbearing age must be confirmed to be non-pregnant through pregnancy tests, and are willing to take effective contraceptive measures during the trial and within ≥ 6 months after the last dose; pregnant and lactating women cannot participate; all male subjects take contraceptive measures during the trial and within ≥ 3 months after the last dose.\n\n5\\. Sign the informed consent form.\n\nExclusion Criteria:\n\n1. Allergic to liposome doxorubicin, etoposide, and ruxolitinib or with severe allergic constitution;\n2. Severe myocardial damage, with myocardial enzyme CK and CK-MB increased more than 3 times ULN (upper limit of normal value).\n3. Patients with heart disease of grade II or above (including grade II) according to the New York Heart Association (NYHA) score.\n4. Subjects who have used a total cumulative dose of doxorubicin ≥300mg\u002Fm2 or a total cumulative dose of epirubicin ≥450mg\u002Fm2, or who have previously used anthracyclines to cause heart disease.\n5. Subjects with severe mental illness;\n6. Severe and uncontrollable infections, such as lung infection, intestinal infection, and sepsis.\n7. Active massive bleeding in visceral organs (including gastrointestinal bleeding, alveolar bleeding, intracranial bleeding, etc.);\n8. Patients who are unable to rely during the trial and\u002For follow-up stage and who are participating in other clinical studies at the same time.\n\n   * For patients who intend to use PD-1 monoclonal antibodies, if the patient has any of the following conditions, PD-1 monoclonal antibodies will not be used, and only the DEP regimen that does not contain PD-1 monoclonal antibodies will be used:\n\n     1. Those who are allergic to PD-1 monoclonal antibody components.\n     2. Abnormal thyroid function.\n     3. Those who have other severe immune reaction tendencies, including immune myocardial injury, immune hepatitis, immune pneumonia, etc.","ALL","1 Year","70 Years",{"count":48,"type":49},20,"ESTIMATED","INTERVENTIONAL",[52],"PHASE4","This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.",[55],"Hemophagocytic Lymphohistiocytoses","NOT_YET_RECRUITING","2024-08-01",{"date":59,"type":60},"2024-08-05","ACTUAL",{"date":57,"type":49},{"date":63,"type":49},"2027-02-01",{"name":5,"class":6}]