[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584533":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":33,"locations":41,"responsibleParty":60,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":25,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":89,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ZCR-CHOP","EXPERIMENTAL","Cycle 1-2 Drug: Zanubrutinib Zanubrutinib will be given at a dose of 160mg，bid，from d1 to d21 in a 21-day cycle Drug: Chidamide Chidamide will be given at a dose of 20 mg after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle Drug: Rituximab Rituximab will be given at a dose of 375 mg\u002Fm2 by IV on day 1 in a 21-day cycle\n\nCycle 3-8 Patients who achieve complete response evaluated by PEC-CT per Lugano 2014 criteria after two course of treatment will continue to take Zanubrutinib, chidamide, and rituximab for up to 8 cycles in total.\n\nPatients who achieve partial response and stable disease will take ZCR combined with CHOP or up to 8 cycles in total.\n\nCHOP : cyclophosphamide 750 mg\u002Fm2 IV D1, Doxorubicin\u002FEpirubicin 50 mg\u002Fm2 IV, vincristine 1.4 mg\u002Fm2 IV \\[maximum total 2 mg\\], and prednisone 30 mg orally tid from d1 to d5 in a 21-day cycle",[13],"Drug: ZCR-CHOP",{"label":15,"type":16,"description":17,"interventionNames":18},"R-CHOP","ACTIVE_COMPARATOR","R-CHOP Rituximab 375 mg\u002Fm2 IV on d1, cyclophosphamide 750 mg\u002Fm2 IV on d1, Doxorubicin\u002FEpirubicin 50 mg\u002Fm2 IV on d1, vincristine 1.4 mg\u002Fm2 IV \\[maximum total 2 mg\\] on d1, and prednisone 30 mg orally tid from d1 to d5 in a 21-day cycle for up to 6 cycles.",[19],"Drug: R-CHOP",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Zanubrutinib, Chidamide, and Rituximab Induction Therapy Sequentially Combined With or Without CHOP",[9],null,{"type":22,"name":15,"description":15,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":31,"role":32},"Zhiming Li, M.D.","Sun Yat-Sen University Cancer Center","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","+86-020-87343292","lizhm@sysucc.org.cn",{"name":39,"role":35,"phone":36,"phoneExt":25,"email":40},"Peng Sun, M.D.","sunp@sysucc.org.cn",[42],{"facility":43,"status":25,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Sun Yat-sen University Cancer Center","Guangzhou","Guangdong","510060","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.25,23.11667,{"lat":53,"lon":52},[56,58,59],{"name":30,"role":35,"phone":57,"phoneExt":25,"email":37},"+86-020-87343350",{"name":39,"role":35,"phone":25,"phoneExt":25,"email":40},{"name":30,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Li Zhiming","Professor","100584533","phase-2-zanubrutinib-chidamide-and-rituximab-induction-with-or-without-chop-versus-r-chop-in-newly-diagnosed-double-expressor-dlbcl-100584533",false,"NCT06890585","Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL","A Randomized, Multicenter, Open-Label Phase II Clinical Study Comparing the Efficacy and Safety of Zanubrutinib, Chidamide, and Rituximab Induction Therapy Sequentially Combined With or Without CHOP Versus R-CHOP in the First-Line Treatment of Patients With Newly Diagnosed Double-Expressor Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Newly diagnosed MYC\u002FBCL2 double-expressor DLBCL confirmed by pathological histology\u002Fclinical imaging, with IHC BCL2 expression ≥50% and MYC expression ≥40%.\n* Male or female patients aged 18-65 years.\n* ECOG score of 0-2.\n* Expected survival time of ≥6 months.\n* Must have at least one evaluable or measurable lesion according to the Lugano 2014 criteria \\[Evaluable lesion: lymph node or extranodal local uptake increased (higher than the liver) on 18F-Fluorodeoxyglucose\u002FPositron Emission Tomography (18FDG\u002FPET) scan, and PET and\u002For Computed Tomography (CT) features consistent with lymphoma; Measurable lesion: nodal lesion with a long diameter \\>15mm or extranodal lesion with a long diameter \\>10mm, with increased 18FDG uptake\\]. Patients with no measurable lesions and diffuse 18FDG uptake in the liver should be excluded.\n* Good major organ function, meeting the following requirements within one week before enrollment: blood routine WBC ≥3×10\\^9\u002FL, Hb ≥80g\u002FL, PLT ≥80×10\\^9\u002FL; normal cardiac and liver function (total bilirubin ≤1.5 times the upper limit of normal, ALT and AST ≤2.5 times the upper limit of normal), normal renal function (serum creatinine ≤1.5 times the upper limit of normal), and no coagulation abnormalities.\n* LVEF ≥50% as measured by echocardiography.\n* Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and be willing to use reliable contraception during the study.\n* Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Special types of DLBCL:Fluid overload-associated large B-cell lymphoma, primary mediastinal large B-cell lymphoma, mediastinal gray zone lymphoma, primary central nervous system (CNS) DLBCL, double-hit DLBCL with BCL2 and MYC rearrangements.\n* Transformed DLBCL (e.g., DLBCL transformed from follicular lymphoma, chronic lymphocytic leukemia\u002Fsmall B-cell lymphoma), secondary CNS involvement of DLBCL.\n* History of other malignancies within the past 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, and carcinoma in situ of the cervix.\n* Major surgery within the past 2 months (excluding diagnostic surgery).\n* Previous treatment for NHL, including chemotherapy, immunotherapy, radiotherapy, monoclonal antibody therapy, or surgical treatment (excluding diagnostic surgery and biopsy).\n* Previous treatment with cytotoxic drugs or anti-CD20 monoclonal antibody therapy for other diseases (e.g., rheumatoid arthritis).\n* Use of any monoclonal antibody within 3 months prior to enrollment, participation in other clinical trials with investigational drugs, or vaccination with live attenuated virus vaccines within 1 month prior to enrollment.\n* Use of hematopoietic growth factors within 2 weeks prior to enrollment.\n* Suspected active or latent tuberculosis.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed fungal infections) within 4 weeks prior to enrollment, or any major systemic infection requiring intravenous antibiotics or hospitalization (excluding tumor fever).\n* History of severe bleeding disorders, such as hemophilia A, hemophilia B, von Willebrand disease, or spontaneous bleeding requiring transfusion or other medical intervention.\n* HIV-positive patients. Active HBV-positive and HCV-positive patients, but those with controlled conditions as judged by the investigator may be cautiously enrolled with effective antiviral intervention.\n* Other severe diseases that may limit participation in this trial, such as uncontrolled diabetes; severe heart failure (NYHA class II or above); acute coronary syndrome within the past 6 months; coronary revascularization within the past 6 months, such as stent implantation, coronary artery bypass grafting, and other heart and large vessel surgeries; severe arrhythmias including frequent premature ventricular contractions, ventricular tachycardia, rapid atrial fibrillation\u002Fflutter, severe bradycardia. Uncontrolled hypertension (greater than 150\u002F100 mmHg). Gastric ulcer (with a risk of perforation as judged by the investigator); active autoimmune diseases; severe hypertension; severe respiratory diseases (e.g., obstructive pulmonary disease and bronchospasm history), such as known interstitial pneumonia or highly suspected interstitial pneumonia; or patients who may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Contraindications to any study drug, including previous treatment with anthracyclines; patients with diabetes who cannot tolerate prednisone treatment in this regimen.\n* History of alcohol abuse or drug abuse.\n* Allergic constitution, or known allergy to any active ingredient, excipient, or murine products, heterologous proteins included in this study.\n* Requirement for continuous treatment with strong CYP3A inhibitors or inducers (see Appendix 6).\n* Severe mental illness.\n* Patients unable to comply with the study and\u002For follow-up phases.\n* Patients unable to swallow study drugs normally.\n* Patients deemed unsuitable for enrollment by the investigator.","ALL","18 Years","65 Years",{"count":75,"type":76},128,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies, which make it a promising regimen for B cell lymphoma. Chidamide is an oral subtype-selective histone deacetylase inhibitor.\n\nThis Randomized, Multicenter, Open-Label Phase II Clinical Study is comparing the efficacy and safety of Zanubrutinib, Chidamide, and Rituximab induction therapy sequentially combined with or without CHOP versus R-CHOP in the first-line treatment of patients with newly diagnosed double-expressor DLBCL.",[82,83,84],"BTK Inhibitors","Histone Deacetylase Inhibitor","Double Express Diffuse Large B-cell Lymphoma",[86,87,88],"Double Expressor Diffuse Large B-cell Lymphoma","zanubrutinib","chidamide","NOT_YET_RECRUITING","2025-03-17",{"date":92,"type":93},"2025-03-24","ACTUAL",{"date":95,"type":76},"2025-06-01",{"date":97,"type":76},"2029-12-31",{"name":62,"class":6},1]