[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631948":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":35,"responsibleParty":56,"collaborators":20,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Chidamide Maintenance","EXPERIMENTAL","Participants with newly diagnosed double-expressor DLBCL who achieve complete response after induction therapy but remain ctDNA MRD-positive will receive chidamide maintenance therapy.",[13],"Drug: Chidamide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Chidamide","Chidamide 20 mg orally on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD assessments will be performed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments at least 3 months apart, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Rong Tao, MD & PhD","STUDY_CHAIR",{"name":26,"affiliation":5,"role":27},"Wenhao Zhang, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","008621-64175590","rao@shca.org.cn",{"name":26,"role":30,"phone":31,"phoneExt":20,"email":34},"zhangwenhao@shca.org.cn",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","20000","China","CN",{"type":45,"coordinates":46},"Point",[47,48],121.45806,31.22222,{"lat":48,"lon":47},[51,54],{"name":52,"role":30,"phone":31,"phoneExt":20,"email":53},"Rong Tao, MD","rtao@shca.org.cn",{"name":55,"role":30,"phone":31,"phoneExt":20,"email":34},"Wenhan Zhang, MD",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Rong Tao","MD & PhD","100631948","phase-2-chidamide-maintenance-for-mrd-positive-double-expressor-dlbcl-in-first-complete-remission-100631948",false,"NCT07507318","Chidamide Maintenance for MRD-Positive Double-Expressor DLBCL in First Complete Remission","A Prospective, Multicenter, Single-Arm, Open-Label Phase 2 Study of Chidamide Maintenance in Patients With Newly Diagnosed Double-Expressor Diffuse Large B-Cell Lymphoma Who Achieve Complete Response After Induction Therapy But Remain ctDNA MRD-Positive","DEL-MRD-CHID","Inclusion Criteria:\n\n* Histologically confirmed diffuse large B-cell lymphoma, CD20-positive.\n* Double-expressor lymphoma confirmed by pathology, defined as MYC expression \\>=40% and BCL2 expression \\>=50% by immunohistochemistry.\n* Complete response after initial induction therapy.\n* Age \\>=18 and \\\u003C=80 years.\n* ECOG performance status 0-2.\n* No prior history of malignant tumor and no concurrent malignancy.\n* International Prognostic Index (IPI) score \\>1.\n* ctDNA MRD-positive at screening\u002Fenrollment.\n* Life expectancy of at least 6 months, in the opinion of the investigator.\n* Written informed consent provided before any study-specific procedure.\n\nExclusion Criteria:\n\n* Failure to achieve complete response after initial induction therapy.\n* Prior organ transplantation.\n* Uncontrolled coagulopathy or active bleeding.\n* Uncontrolled cardiovascular or cerebrovascular disease, including left ventricular ejection fraction \\\u003C50%, connective tissue disease, or severe active infection.\n* Major organ surgery within 6 weeks before screening.\n* Screening laboratory abnormalities not attributable to lymphoma, including: neutrophil count \\\u003C1.5 x 10\\^9\u002FL; platelet count \\\u003C80 x 10\\^9\u002FL (or \\\u003C50 x 10\\^9\u002FL in patients with bone marrow involvement); total bilirubin \\>1.5 x upper limit of normal; ALT\u002FAST \\>2.5 x upper limit of normal, or \\>5 x upper limit of normal in patients with hepatic involvement; serum creatinine \\>1.5 x upper limit of normal.\n* Active hepatitis B not meeting protocol-defined virologic criteria for enrollment; patients with positive HBsAg or positive HBcAb require HBV DNA testing and must meet protocol-specified thresholds.\n* HIV infection.\n* Ongoing antitumor therapy for lymphoma or another malignancy.\n* Drug abuse or chronic alcohol abuse that may interfere with study evaluation.\n* Psychiatric illness or any condition resulting in inability to comply with the protocol.\n* Requirement for ongoing treatment with strong or moderate CYP3A inhibitors or inducers; patients exposed to these agents within 7 days before first study dose, or within fewer than 5 half-lives, are not eligible.\n* Inability to swallow capsules or clinically significant gastrointestinal disorders that may affect drug absorption, including malabsorption syndrome, bariatric surgery, inflammatory bowel disease, or partial\u002Fcomplete bowel obstruction.\n* Any other uncontrolled medical condition that, in the investigator's judgment, may compromise safety, interfere with oral drug absorption or metabolism, or place the participant at excessive risk.","ALL","18 Years","80 Years",{"count":72,"type":73},69,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","This is a prospective, multicenter, single-arm, open-label phase 2 study designed to evaluate the efficacy and safety of chidamide maintenance in adults with newly diagnosed double-expressor diffuse large B-cell lymphoma (DLBCL) who achieve complete response after induction therapy but remain ctDNA minimal residual disease (MRD)-positive. Eligible participants will receive oral chidamide 20 mg on Days 1, 4, 8, and 11 of each 21-day cycle. ctDNA MRD will be assessed every 12 weeks. Treatment will continue until two consecutive MRD-negative assessments, disease progression, intolerable toxicity, withdrawal of consent, or completion of 2 years of maintenance. The primary objectives are to evaluate ctDNA MRD negativity and 2-year progression-free survival. Secondary objectives include event-free survival, overall survival, and safety.",[79],"Diffuse Large B-Cell Lymphoma",[17,81,82,83,84],"Tucidinostat","Minimal Residual Disease","Maintenance Therapy","Double-Expressor Lymphoma","2026-06-16",{"date":87,"type":88},"2026-06-18","ACTUAL",{"date":85,"type":88},{"date":91,"type":73},"2029-06-30",{"name":58,"class":6},1]