[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ou Bai, MD\u002FPHD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":118},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100645142","phase-2-orelabrutinib-combined-with-induction-therapy-followed-by-sequential-monotherapy-maintenance-in-mcd-subtype-diffuse-large-b-cell-lymphoma-100645142",false,"NCT07677813","Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma","Efficacy and Safety of Orelabrutinib Combined With Induction Therapy Followed by Sequential Monotherapy Maintenance in MCD Subtype Diffuse Large B-cell Lymphoma: a Single-center, Single-arm, Prospective Study","Inclusion Criteria:\n\n* Patients of any gender, aged ≥18 years;\n* Pathologically, NGS, and imaging confirmed diagnosis of MCD subtype DLBCL (including IP-LBCLs);\n* No prior treatment history;\n* Serum creatinine ≤2 times the upper limit of normal or eGFR ≥40 ml\u002Fmin;\n* Bilirubin \\\u003C1.5 times the upper limit of normal;\n* Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;\n* Patients with a history of stroke or bleeding within the past 6 months;\n* Patients requiring treatment with strong CYP3A inhibitors;\n* Patients with comorbid autoimmune deficiency diseases or active hepatitis virus infection;\n* Patients with a history of organ transplantation;\n* Patients with a history of or concurrent other malignant tumors.","ALL","18 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-center, single-arm, prospective study aimed at evaluating the efficacy and safety of orelabrutinib combined with an induction regimen followed by monotherapy maintenance in patients with MCD subtype diffuse large B-cell lymphoma (DLBCL). The primary endpoint is the 2-year progression-free survival (PFS) rate; secondary endpoints include overall response rate (ORR), complete response rate (CRR), overall survival (OS), and treatment-related adverse events (TRAEs). The study plans to enroll 66 patients.",[26],"DLBCL - Diffuse Large B Cell Lymphoma",[28,29,30,31,32],"orelabrutinib","DLBCL","chemotherapy","Maintenance therapy","MCD subtype","NOT_YET_RECRUITING","2026-06-25",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":20},"2026-06-16",{"date":41,"type":20},"2031-12-31",{"name":43,"class":44},"Ou Bai, MD\u002FPHD","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100633371","a-real-world-study-of-pirtobrutinib-in-cbtki-resistantintolerant-mature-b-cell-lymphoma-100633371","NCT07525817","A Real-World Study of Pirtobrutinib in cBTKi-Resistant\u002FIntolerant Mature B-Cell Lymphoma","A Prospective, Multicenter, Real-World Study of Pirtobrutinib in Patients With Mature B-Cell Lymphoma Resistant or Intolerant to Covalent Bruton Tyrosine Kinase Inhibitors","Inclusion Criteria:\n\n* Age ≥18 years;\n* Histopathological confirmation of mature B-cell lymphoma, primarily including CLL\u002FSLL, MCL, FL, MZL, WM\u002FLPL, etc.;\n* Disease progression and\u002For intolerance after prior treatment with ≥1 cBTKi (including ibrutinib, ibrutinib, zanubrutinib, or acitinib);\n* ECOG PS 0-2;\n* Adequate liver and kidney function: the following criteria must be met simultaneously: 1) AST and ALT ≤ 3×ULN; 2) Total bilirubin ≤ 1.5×ULN; 3) Creatinine clearance rate ≥ 30 mL\u002Fmin;\n* Participants must be voluntary and capable of completing the study procedures and follow-up examinations;\n* Informed consent must be obtained voluntarily prior to screening.\n\nExclusion Criteria:\n\n* Patients with known allergic reactions to any component or excipient of piteutinib;\n* Patients concurrently participating in other clinical studies;\n* A history of clinically significant, uncontrolled cardiac,\n* Cardiovascular disease, or myocardial infarction within 6 months prior to planned initiation of piteutinib therapy;\n* Uncontrolled systemic bacterial, viral, fungal, or parasitic infections; current use of potent CYP3A4 inhibitors or inducers and\u002For potent P-gp inhibitors;\n* Positive human immunodeficiency virus (HIV) testing;\n* Active hepatitis B or C: 1) Patients with positive hepatitis B virus (HBV) DNA testing and controlled disease status may be enrolled with investigator approval. For HBV DNA-positive patients, concurrent antiviral therapy is required. 2) Patients with prior hepatitis C virus (HCV) infection history who have completed antiviral therapy with viral loads below the quantitative limit may be enrolled;\n* Based on the investigator's assessment, participants may be unable to complete all study protocol requirements, including follow-up visits, and\u002For adhere to all study procedures;\n* A history of other clinically significant diseases or comorbidities; and any safety risks or potential interference with study completion as evaluated by investigators.",{"count":54,"type":20},40,"OBSERVATIONAL","This is a prospective, multicenter, real-world study to evaluate the efficacy and safety of pirtobrutinib in patients with mature B-cell lymphoma who are resistant or intolerant to prior covalent BTK inhibitors. The primary endpoint is overall response rate (ORR). Secondary endpoints include best overall response (BOR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. A total of 40 patients will be enrolled across 8 centers in China.",[58],"Mature B-Cell Lymphoma",[60,61,62],"Pirtobrutinib","Covalent BTK inhibitor","Mature B-cell lymphoma","2026-04-07",{"date":65,"type":37},"2026-04-13",{"date":67,"type":20},"2026-04-01",{"date":69,"type":20},"2028-12-31",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100630856","phase-3-chidamide-for-maintenance-treatment-of-hbv-infected-diffuse-dlbcl-in-patients-initially-treated-with-r-chop-100630856","NCT07493109","Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP","Evaluation of the Efficacy and Safety of Chidamide for Maintenance Treatment of HBV-infected Diffuse DLBCL in Patients Initially Treated With R-CHOP: A Prospective, Multicenter, Open-label Phase III Clinical Trial","Inclusion Criteria:\n\n1. Both sexes, age range ≥18 years and ≤80 years.\n2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except local radiotherapy used to relieve tumor-related symptoms), or surgical treatment (except for tumor or pathological tissue biopsy and surgical resection not targeting lymphoma). Patients must have achieved complete response (CR) after 6 cycles of R-CHOP chemotherapy, confirmed by imaging (CT\u002FPET-CT), bone marrow biopsy (if positive at baseline), and clinical assessment. Eligible patients will be randomly assigned in a 1:1 ratio to either the chidamide maintenance treatment group (experimental group) or the observation group (control group).\n3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): Diffuse large B-cell lymphoma (DLBCL), and CD20-positive; Positive result for hepatitis B infection, defined as HBsAg positive, HBV DNA positive (\\>2000 IU\u002FmL), or histopathological evidence of chronic HBV infection (without cirrhosis). Patients receiving ongoing antiviral therapy (e.g., nucleos(t)ide analogs) must have been on a stable regimen for ≥4 weeks prior to enrollment.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n5. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the parameters below within 2 weeks prior to assessment): Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, Platelet count (PLT) ≥ 90 × 10⁹\u002FL; Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis).\n6. Life expectancy of at least 6 months, as judged by the investigator.\n7. Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, and fertile patients unwilling to use contraceptive measures.\n2. Patients with a history of clinically significant QTc interval prolongation (males \\> 450 ms, females \\> 470 ms), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 year, congestive heart failure (CHF), or symptomatic coronary artery disease requiring medication.\n3. Patients who have undergone organ transplantation.\n4. Patients who received treatment for prior myelotoxicity as symptomatic therapy within 7 days before enrollment.\n5. Patients with active bleeding.\n6. Patients with a history or current diagnosis of thrombosis, embolism, cerebral hemorrhage, cerebral infarction, or other related conditions.\n7. Patients with active infection, or persistent fever within 14 days before enrollment.\n8. Patients who have not completed at least 6 weeks of recovery after major organ surgery.\n9. Patients with abnormal liver function (total bilirubin \\> 1.5 × upper limit of normal \\[ULN\\], ALT\u002FAST \\> 2.5 × ULN, or \\> 5 × ULN in patients with liver involvement) or abnormal renal function (serum creatinine \\> 1.5 × ULN).\n10. Patients with mental disorders or those from whom informed consent cannot be obtained.\n11. Patients with drug abuse or chronic alcoholism that may interfere with the evaluation of trial results.\n12. Patients with lymphoma involving the central nervous system (CNS).\n13. Patients deemed by the investigator to be unsuitable for participation in this study.","80 Years",{"count":80,"type":20},200,[82],"PHASE3","To evaluate the efficacy and safety of chidamide monotherapy as maintenance treatment in patients with diffuse large B-cell lymphoma (DLBCL) and HBV infection following initial response to R-CHOP therapy, and to provide evidence for the clinical application of chidamide.",[85],"Diffuse Large B-Cell Lymphoma (DLBCL)",[87],"HBV-infected DLBCL","RECRUITING","2026-03-20",{"date":91,"type":37},"2026-03-25",{"date":93,"type":20},"2026-05-30",{"date":95,"type":20},"2030-09-30",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":45},"100630859","phase-2-chidamide-combination-with-r-mini-chop-followed-by-chidamidecd20-maintenance-in-elderly-newly-diagnosed-mycbcl2-dlbcl-100630859","NCT07493148","Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC\u002FBCL2+ DLBCL","A Phase II, Open-label, Single-arm Clinical Study of Chidamide in Combination With the R-mini CHOP Regimen, Followed by Chidamide Plus CD20 as Maintenance Therapy, in Elderly Patients With Newly Diagnosed MYC\u002FBCL2 Co-expressor DLBCL","Inclusion Criteria:\n\n1. Age ≥ 70 years;\n2. No prior treatment for DLBCL;\n3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② \"MYC\u002FBCL2 double-expressor\": Immunohistochemistry (IHC) per WHO criteria: MYC ≥ 40%, and BCL2 ≥ 50%; ③ Non-\"double-hit\" or \"triple-hit\" lymphoma;\n4. At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma;\n5. International Prognostic Index (IPI) score \\> 1;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2;\n7. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the indicators below within 2 weeks prior to assessment): ① Hematology: Hemoglobin (Hb) ≥ 90 g\u002FL, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, Platelet count (PLT) ≥ 90 × 10⁹\u002FL; ② Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis);\n8. Life expectancy ≥ 6 months;\n9. Understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Central nervous system (CNS) involvement;\n2. Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma; specific subtypes of DLBCL (e.g., primary CNS DLBCL, etc.);\n3. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;\n4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or chidamide;\n5. HIV\u002FHCV infection;\n6. If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative DNA may be enrolled.\n7. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases;\n8. Inability to comply with the study protocol due to psychiatric or other unknown reasons;\n9. For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks after the last dose of chidamide or 12 months after the last dose of rituximab, whichever is longer; pregnant or breastfeeding women;\n10. Other conditions deemed unsuitable for participation in this trial.","70 Years",{"count":106,"type":20},50,[23],"Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC\u002FBCL2 double-expressor DLBCL.",[85],[111],"newly diagnosed MYC\u002FBCL2 double-expressor DLBCL",{"date":91,"type":37},{"date":114,"type":20},"2026-04-30",{"date":116,"type":20},"2029-12-30",{"name":43,"class":44},""]