[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650791":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":22,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":22,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":22,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":22,"overallStatus":76,"whyStopped":22,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Golidocitinib Combined with Doxorubicin\u002FEpirubicin","EXPERIMENTAL","Participants will receive golidocitinib 150 mg orally once daily in combination with either doxorubicin 50 mg\u002Fm² intravenously on Day 1 or epirubicin 60-90 mg\u002Fm² intravenously on Day 1 of each 21-day cycle for up to 6 cycles. Participants who achieve a complete response (CR) or partial response (PR) may receive golidocitinib monotherapy as maintenance treatment for up to 12 months, as determined by the investigator.",[13,14,15],"Drug: Golidocitinib","Drug: Doxorubicin","Drug: Epirubicin",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Golidocitinib","150mg, po, qd",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Doxorubicin","50 mg\u002Fm² intravenously on Day 1 of each 21-day cycle",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Epirubicin","60-90 mg\u002Fm² intravenously on Day 1 of each 21-day cycle",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},"Qingqing Cai, MD. PhD.","CONTACT","02087342823","caiqq@sysucc.org.cn",[38],{"facility":39,"status":22,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University","Guangzhou","Guangdong","51000","China","CN",{"type":46,"coordinates":47},"Point",[48,49],113.25,23.11667,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":22,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Qingqing Cai","Principal Investigator","100650791","phase-2-golidocitinib-plus-anthracycline-based-therapy-for-untreated-nodal-t-follicular-helper-tfh-cell-lymphoma-100650791",false,"NCT07753642","Golidocitinib Plus Anthracycline-based Therapy for Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma","A Phase II, Prospective, Single-Arm Clinical Trial Evaluating the Safety and Efficacy of Golidocitinib Combined With an Anthracycline-Based Regimen as First-Line Treatment for Patients With Nodal T-follicular Helper (TFH) Cell Lymphoma","Key inclusion Criteria:\n\n1. Histologically confirmed nodal T-follicular helper (TFH) cell lymphoma according to the 2022 WHO classification.\n2. Previously untreated with systemic anti-lymphoma therapy.\n3. Age ≥18 and \\\u003C75 years.\n4. At least one measurable or evaluable lesion according to the Lugano 2014 criteria.\n5. An expected survival time of more than 12 weeks.\n6. An ECOG performance status score of 0-1.\n7. Adequate organ and bone marrow function.\n8. Provision of written informed consent and willingness to comply with all study procedures.\n\nKey exclusion Criteria:\n\n1. Hemophagocytic syndrome.\n2. Central nervous system or meningeal involvement by lymphoma.\n3. Patients with a history of other malignancies within the past 5 years or concurrent malignancies, except for basal cell carcinoma of the skin.\n4. Patients receiving potent CYP3A inducers or inhibitors, vitamin K antagonists, antiplatelet agents, or anticoagulants.\n5. Patients with active infections, including tuberculosis, HIV infection, active hepatitis B, or active hepatitis C.\n6. Patients with severe or uncontrolled cardiovascular disease.\n7. Patients with a history of interstitial lung disease, except for asymptomatic radiation-induced interstitial lung disease.\n8. Patients with gastrointestinal conditions that may interfere with oral administration or drug absorption.\n9. Patients with known hypersensitivity to golidocitinib or its excipients.\n10. Pregnant or breastfeeding women and participants of childbearing potential unwilling to use effective contraception.\n11. Patients who have received systemic corticosteroids or other immunosuppressive therapy within 14 days before the start of study treatment.\n12. Patients considered unsuitable for participation by the investigator.","ALL","18 Years","75 Years",{"count":68,"type":69},47,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","This is a prospective, multicenter, open-label, single-arm, phase II clinical study to evaluate the safety and efficacy of golidocitinib in combination with an anthracycline-based regimen as first-line treatment for patients with previously untreated nodal T-follicular helper (TFH) cell lymphoma.",[75],"Nodal T-follicular Helper Cell Lymphoma","NOT_YET_RECRUITING","2026-08-03",{"date":79,"type":80},"2026-08-07","ACTUAL",{"date":82,"type":69},"2026-08-15",{"date":84,"type":69},"2029-08-30",{"name":5,"class":6},1]