[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"btk-inhibitors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:btk-inhibitors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,65,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100639937","phase-1-cd20-monoclonal-antibody-combined-with-btk-inhibitor-for-the-treatment-of-refractory-immune-related-cytopenia-100639937",false,"NCT07574073","CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia","Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)","Inclusion Criteria:\n\n* Diagnosed with refractory immune-related cytopenia, including immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA);\n* Age ranging from 18 to 80 years old (inclusive of 18 and 80);\n* Expected survival time \\> 12 months;\n* Good function of major organs:\n\n  1. liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal;\n  2. kidney function: creatinine \\\u003C 100 μmol\u002FL;\n  3. lung function: indoor oxygen saturation ≥ 95%;\n  4. heart function: left ventricular ejection fraction (LVEF) ≥ 50%;\n* Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion;\n* Karnofsky score ≥ 60, ECOG ≤ 2 points.\n\nExclusion Criteria:\n\n* Women who are pregnant (with positive urine\u002Fblood pregnancy test results) or breastfeeding;\n* Those who have severe underlying heart diseases when participating in this study, including:\n\n  1. clinically significant atrial fibrillation (AF),\n  2. cardiac conduction block,\n  3. myocardial infarction (within 1 year),\n  4. congestive heart failure (CHF);\n  5. cardiac echocardiography LVEF \\\u003C 50%;\n  6. New York Heart Association (NYHA) cardiac function classification of III-IV grade;\n* Those with active bleeding or bleeding tendencies, and those who need to take anticoagulant drugs;\n* Those with organ dysfunction or uncontrollable coexisting diseases;\n* History of malignant tumors;\n* Those with active chronic hepatitis B or active hepatitis C;\n* Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n* Those with uncontrollable infectious diseases;\n* As determined by the investigator, other unsuitable conditions exist.","ALL","18 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).",[27,28,29,30],"Anti-CD20 Monoclonal Antibody","BTK Inhibitors","Immune Thrombocytopenia (ITP)","Autoimmune Hemolytic Anemia (AIHA)","NOT_YET_RECRUITING","2026-05-19",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":21},"2026-06-01",{"date":39,"type":21},"2028-05-31",{"name":41,"class":42},"Qi deng","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100614774","zanubrutinib-and-acalabrutinib-use-and-risk-of-atrial-fibrillation-in-patients-with-chronic-b-cell-malignancies-100614774","NCT07283965","Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies","Inclusion Criteria:\n\n* adult patients\n* diagnose with chronic B-cell malignancies\n* exposed to zanubrutinib or acalabrutinib\n\nExclusion Criteria:\n\n* none",{"count":50,"type":21},15000,"OBSERVATIONAL","Background. Zanubrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown.\n\nObjectives. Our aim was to examine the risk of developing incident AF with zanubrutinib exposure compared with acalabrutinib exposure.\n\nMethods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to zanubrutinib or acalabrutinib. Patients will be divided into 2 groups based on zanubrutinib or acalabrutinib exposure. After propensity score matching (PSM), Cox proportional hazard models will be used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) to compare the 2 matched groups. The appropriateness of the proportional hazard assumption will be examined and risk differences (RDs) will be used if appropriate. Results will summarized with the use of Kaplan-Meier survival curves.",[54,28,55],"Chronic B-cell Malignancies","Cardiovascular Diseases","2025-12-12",{"date":58,"type":35},"2025-12-16",{"date":60,"type":21},"2025-12-22",{"date":62,"type":21},"2026-03-31",{"name":64,"class":42},"University Hospital, Caen",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100586641","phase-2-zanubrutinib-plus-gcvp-obinutuzumab-cyclophosphamide-vindesine-prednisolone-in-previously-untreated-follicular-lymphoma-100586641","NCT06918015","Zanubrutinib Plus GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma","A Prospective, Single-arm, Phase II Study of Zanubrutinib in Combination With GCVP (Obinutuzumab, Cyclophosphamide, Vindesine, Prednisolone) in Previously Untreated Follicular Lymphoma","Inclusion Criteria\n\n1. Participate in the clinical study voluntarily, fully understand and be informed of the study, sign the informed consent in person, willing to follow and be able to complete all test procedures.\n2. 18-80 years old (inclusive), all genders.\n3. Histopathologically confirmed grade 1-3a follicular lymphoma (FL) at stage III\u002FIV or extensive stage II disease not suitable for radiotherapy, with at least one evaluable lesion (short axis ≥ 1.5 cm), meeting treatment indications according to GELF criteria or having a strong treatment desire.\n4. No prior anti-tumor therapy, such as chemotherapy, radiotherapy, immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer).\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3.\n6. Adequate bone marrow and organ function, no serious hematopoietic dysfunction, abnormal heart, lung, liver, kidney function and immune deficiency.\n\n   * Blood routine: White blood cell count ≥ 3.0×109\u002FL, Absolute neutrophil count ≥ 1.5×109\u002FL (use of granulocyte colony stimulating factor is permitted), Hemoglobin ≥ 9.0 g\u002FdL (pre-transfusion or use of recombinant human erythropoietin is permitted), Platelet count ≥ 75×109\u002FL (transfusion is permitted to reach this level). If peripheral blood abnormalities are due to lymphoma infiltration of the bone marrow or spleen, enrollment may be considered at the investigator's discretion.\n   * Echocardiogram: Left ventricular ejection fraction (LVEF) ≥ 50%.\n   * Liver function: serum bilirubin ≤ 2.5 times the upper limit of normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal value (AST is allowed if liver is involved, ALT ≤ 5 times the upper limit of normal value).\n   * Renal function: creatinine clearance ≥ 60 mL\u002Fmin (estimated according to the Cockcroft-Gault formula).\n   * Coagulation function: INR ≤ 1.5 times the upper limit of normal value; PT and APTT ≤ 1.5 times the upper limit of normal value.\n7. Life Expectancy of at least 6 months.\n8. Men and women of childbearing potential must use contraception during the study and for at least 90 days after the last dose of study medication.\n\nExclusion Criteria\n\n1. Central nervous system involvement secondary to lymphoma.\n2. Known severe allergic reactions to humanized or murine monoclonal antibodies, or known contraindications to any drug in the regimen.\n3. History of other active malignant diseases within 2 years prior to study entry, but eligibility for inclusion: a) adequately treated carcinoma in situ of the cervix; b) local basal cell carcinoma or squamous cell carcinoma of skin; c) Pre-existing malignant disease that is under control and has undergone local radical treatment (surgical or other forms).\n4. History of Human Immunodeficiency Virus (HIV) infection and\u002For other acquired Immunodeficiency syndrome. During screening period, patients with hepatitis B virus (HBV) surface antigen or hepatitis C virus (HCV) antibody positive must further test HBV DNA (no more than 2000 iu\u002Fml) and HCV RNA (not exceed the method detection limit). Those ruling out active HBV or HCV infection are permitted to participate in the study. Carriers of the HBV, those with stable HBV after treatment or cured of HCV are also allowed to be enrolled.\n5. Any active infections, including but not limited to bacterial, fungal or viral infections, that require systemic anti-infective treatment within 14 days prior to initiation treatment.\n6. Major surgery was performed within 28 days prior to initiation treatment.\n7. Combined with severe or uncontrolled disease, including but not limited to congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer, severe hemorrhagic diseases (such as hemophilia, von willebrand disease) or spontaneous bleeding.\n8. History of stroke or intracranial hemorrhage within 6 months prior to initiation treatment.\n9. Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required.\n10. History of severe neurological or psychiatric disorders, including but not limited to dementia or epilepsy.\n11. Conditions related to drug abuse or medical, psychological and social issues that may interfere with study participation or outcome evaluation.\n\n    Investigator Discretion: Any patient deemed unsuitable for enrollment by the investigator.\n12. Patients deemed unsuitable for the study by investigators.",{"count":73,"type":21},58,[75],"PHASE2","Previously untreated patients with follicular lymphoma are treated with the ZGCVP regimen (zanubrutinib, obinutuzumab, cyclophosphamide, vindesine, prednisolone) for 6 cycles.",[28,78,79],"Follicular Lymphoma","Immunochemotherapy",[81,82,83,84],"BTK inhibitors","follicular lymphoma","immunochemotherapy","first-line therapy","2025-04-12",{"date":87,"type":35},"2025-04-15",{"date":89,"type":21},"2025-05-01",{"date":91,"type":21},"2030-05-01",{"name":93,"class":42},"Zhejiang Cancer Hospital",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":94},"100584533","phase-2-zanubrutinib-chidamide-and-rituximab-induction-with-or-without-chop-versus-r-chop-in-newly-diagnosed-double-expressor-dlbcl-100584533","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.","65 Years",{"count":104,"type":21},128,[75],"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.",[28,108,109],"Histone Deacetylase Inhibitor","Double Express Diffuse Large B-cell Lymphoma",[111,112,113],"Double Expressor Diffuse Large B-cell Lymphoma","zanubrutinib","chidamide","2025-03-17",{"date":116,"type":35},"2025-03-24",{"date":118,"type":21},"2025-06-01",{"date":120,"type":21},"2029-12-31",{"name":122,"class":42},"Li Zhiming"]