[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633344":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":41,"centralContacts":45,"locations":54,"responsibleParty":72,"collaborators":24,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":24,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":24,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":57,"whyStopped":24,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Beijing Tongren Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MEPL-G group","EXPERIMENTAL","All enrolled patients may initiate induction therapy with the MEPL-G regimen after completing baseline imaging and laboratory examinations.\n\nThe detailed administration is as follows:\n\nDoses of etoposide, golidocitinib, pegaspargase, and methylprednisolone are fixed. The optimal dose of liposomal mitoxantrone will be determined based on dose-limiting toxicity (DLT). In the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg\u002Fm²\u002Fd on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg\u002Fm²\u002Fd on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially. One cycle is 3 weeks, for a total of 6 cycles.\n\nPatients achieving CR or PR after 2 cycles may be referred for allogeneic hematopoietic stem cell transplantation.\n\nPatients with CR or PR after 2 cycles who are ineligible for transplantation may continue MEPL-G for a total of 6 cycles, followed by maintenance therapy with golidocitinib monotherapy",[13,14,15,16,17],"Drug: Mitoxantrone liposome","Drug: Etoposide","Drug: Pegaspargase (PEG) Asparaginase","Drug: methylprednisolone","Drug: golidocitinib",[19,25,29,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Mitoxantrone liposome","In the Phase Ib part, 3 patients will be enrolled at the starting dose of liposomal mitoxantrone: 18 mg\u002Fm²\u002Fd on day 1, every 3 weeks (q3w). If no DLT occurs, the recommended phase 2 dose (RP2D) will be 18 mg\u002Fm²\u002Fd on day 1 q3w. If DLT occurs, the dose will be de-escalated sequentially (18→16→14→12 mg\u002Fm²\u002Fd on day 1 q3w).",[9],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Etoposide","100mg\u002Fm²\u002Fd，d1、d8，q3w",[9],{"type":20,"name":30,"description":31,"armGroupLabels":32,"otherNames":24},"Pegaspargase (PEG) Asparaginase","2000IU\u002Fm²\u002Fd，d5，q3w",[9],{"type":20,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"methylprednisolone","15mg\u002Fkg\u002Fd，d1-3 7.5mg\u002Fkg\u002Fd，d4-7\n\n1mg\u002Fkg\u002Fd d8-14 10mg\u002Fd，d15-21",[9],{"type":20,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"golidocitinib","150mg\u002Fd，d1-d21，q3w",[9],[42],{"name":43,"affiliation":5,"role":44},"Liang Wang","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},"Liang Wang, M.D.","CONTACT","+861058266633","wangliangtrhos@126.com",{"name":52,"role":48,"phone":24,"phoneExt":24,"email":53},"Jia Cong, M.D.","congjia21@163.com",[55],{"facility":56,"status":57,"city":58,"state":24,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Beijing Tongren Hospital, Capital Medical University","RECRUITING","Beijing","100730","China","CN",{"type":63,"coordinates":64},"Point",[65,66],116.39723,39.9075,{"lat":66,"lon":65},[69,70,71],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},{"name":52,"role":48,"phone":24,"phoneExt":24,"email":53},{"name":47,"role":44,"phone":24,"phoneExt":24,"email":24},{"type":44,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"LIANG WANG","Director of Department of Hematology in Beijing Tongren Hospital","100633344","phase-1-combination-of-mitoxantrone-liposome-and-etoposide-dexamethasone-pegaspargase-and-golidocitinib-mepl-g-in-the-treatment-of-nkt-cell-lymphoma-associated-hemophagocytic-lymphohistiocytosis-nktcl-hlh-100633344",false,"NCT07525466","Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK\u002FT-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH)","Combination of Mitoxantrone Liposome and Etoposide, Dexamethasone, Pegaspargase and Golidocitinib (MEPL-G) in the Treatment of NK\u002FT-cell Lymphoma Associated Hemophagocytic Lymphohistiocytosis (NKTCL-HLH): a Prospective, Multi-center, Single Arm, Phase Ib\u002FII Clinical Trial","Inclusion Criteria:\n\n* Histologically confirmed extranodal NK\u002FT-cell lymphoma.\n* Meeting the HLH-2004 diagnostic criteria (≥ 5 criteria).\n* Age ≥ 18 years, regardless of gender.\n* Negative HIV antigen or antibody.\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac echocardiography.\n* No active visceral bleeding (e.g., gastrointestinal, pulmonary, cerebral).\n* No uncontrolled infection (e.g., pulmonary infection, intestinal infection).\n* Negative HCV antibody; or positive HCV antibody with negative HCV RNA.\n* Negative HBsAg and negative HBcAb. If either is positive, peripheral blood HBV DNA load must be \\\u003C 1×10³ copies\u002FmL to be eligible.\n* Signed written informed consent and ability to understand and comply with all study requirements.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) cardiac function class ≥ II;\n* Female patients who are pregnant or breastfeeding;\n* Known hypersensitivity to any of the study drugs;\n* Presence of other concurrent malignancies (except non-melanoma skin cancer);\n* Concurrent central nervous system lymphoma infiltration;\n* Severe psychiatric disorders or inability to comply with follow-up;\n* Severe renal dysfunction (glomerular filtration rate \\\u003C 15 mL\u002Fmin);\n* Severe liver cirrhosis (MELD score \\> 20);\n* History of acute or chronic pancreatitis;\n* Simultaneous participation in another clinical trial.","ALL","18 Years",{"count":85,"type":86},25,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","Extranodal NK\u002FT-cell lymphoma (NKTCL) is an aggressive EBV-associated lymphoma with poor prognosis, highly prevalent in China. Early-stage NKTCL achieves favorable long-term survival, while advanced disease shows dismal outcomes with no standard therapy. Notably, 10%-20% of patients develop secondary hemophagocytic lymphohistiocytosis (NKTCL-HLH), a life-threatening complication with median survival \\\u003C2 months and mortality over 90%. Current treatments fail to simultaneously control lymphoma and hyperinflammation, with poor tolerance and high resistance.\n\nThe JAK\u002FSTAT pathway drives EBV-induced inflammation and tumor progression. Golidocitinib, a selective JAK1 inhibitor, demonstrates potent anti-NKTCL activity and rapid inflammation control. Liposomal mitoxantrone offers targeted efficacy with lower toxicity, while etoposide, methylprednisolone, and pegaspargase provide synergistic anti-tumor and anti-HLH effects.\n\nThis study proposes the novel MEPL-G regimen (liposomal mitoxantrone, etoposide, methylprednisolone, pegaspargase, golidocitinib) for NKTCL-HLH. By targeting both HLH and NKTCL, this combination aims to achieve rapid disease control, improve tolerance, and prolong survival, addressing the unmet critical clinical need for this high-risk population.",[93,94],"Extranodal NK T Cell Lymphoma","Hemophagocytic Lymphohistiocytosis (HLH)",[96,97,98,99,100],"extranodal NK\u002FT-cell lymphoma","hemophagocytic lymphohistiocytosis","Mitoxantrone Liposome","Golidocitinib","JAK1","2026-04-07",{"date":103,"type":104},"2026-04-13","ACTUAL",{"date":106,"type":104},"2026-04-01",{"date":108,"type":86},"2028-09-30",{"name":5,"class":6},1]