[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pirtobrutinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pirtobrutinib":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,62],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100650276","phase-2-pirtobrutinib--r-chop-for-untreated-non-gcb-dlbcl-100650276",false,"NCT07744737","Pirtobrutinib + R-CHOP for Untreated Non-GCB DLBCL","A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) for the Treatment of Previously Untreated Non-GCB DLBCL","Inclusion Criteria:\n\n1. Histopathologically confirmed non-GCB diffuse large B-cell lymphoma (DLBCL) (per the 2016 WHO diagnostic criteria);\n2. Whole-body PET\u002FCT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per the 2014 Lugano Criteria);\n3. Age 18-80 years, with estimated survival \\> 3 months;\n4. No prior anti-lymphoma treatment;\n5. Able to provide written informed consent and comply with scheduled study visits and required procedures specified in the protocol;\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n7. Adequate organ and bone marrow function, defined as follows: Hematology: Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL; platelet count (PLT) ≥ 50 × 10⁹\u002FL; hemoglobin (HGB) ≥ 8.0 g\u002FdL. No administration of granulocyte growth factors, platelet transfusions or red blood cell transfusions within 7 days before testing. Liver function: Total serum bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. Renal function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance (CCr) ≥ 50 mL\u002Fmin. Cardiac function: New York Heart Association (NYHA) functional class \\\u003C III; left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography. Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ upper limit of normal +10 s; prothrombin time (PT) ≤ upper limit of normal +3 s. Thyroid function: Baseline thyroid-stimulating hormone (TSH) within normal range, or abnormal baseline TSH with normal T3\u002FT4 and absence of related clinical symptoms.\n8. Female subjects of childbearing potential, or male subjects whose sexual partners are females of childbearing potential, must adopt effective contraceptive measures throughout the treatment period and for 90 days after the last treatment administration.\n\nExclusion Criteria:\n\n1. Central nervous system involvement;\n2. History of hypersensitivity to the study drug, similar agents, or excipients;\n3. Concurrent other malignancies requiring treatment or intervention;\n4. Major surgical procedure performed within 4 weeks prior to treatment (excluding vascular access catheterization or biopsy);\n5. Any life-threatening disease, medical condition, or organ dysfunction that, in the Investigator's opinion, may compromise patient safety or adherence to study procedures;\n6. Poorly controlled cardiac symptoms or diseases, including: i. Heart failure of NYHA Class ≥ II; ii. Unstable angina pectoris; iii. Myocardial infarction within the past 12 months; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n7. Patients with active bleeding;\n8. Uncontrolled active systemic bacterial, viral, fungal or parasitic infection (excluding fungal nail infection), or other clinically significant active disease process that renders the patient unsuitable for participation in this trial as judged by the Investigator.\n9. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome (AIDS).\n10. Patients with active chronic hepatitis B or active hepatitis C are excluded.Patients positive for hepatitis B surface antigen, hepatitis B core antibody or hepatitis C virus antibody during screening must undergo further testing for HBV-DNA and HCV-RNA. Patients with stable hepatitis B after antiviral therapy (HBV-DNA \\\u003C 2500 copies\u002FmL or 500 IU\u002FmL) and cured hepatitis C patients (HCV-RNA below the lower limit of detection) are eligible for enrollment.\n11. Confirmed prior history of neurological or psychiatric disorders, including epilepsy or dementia;\n12. Pregnant or lactating women;\n13. Received any other investigational product within 1 month prior to the first dose;\n14. Other conditions that, in the Investigator's judgment, may interfere with the evaluation of efficacy or safety of the study treatment.","ALL","18 Years","80 Years",{"count":20,"type":21},34,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To evaluate the efficacy and safety of pirtobrutinib combined with R-CHOP in patients with newly diagnosed non-GCB diffuse large B-cell lymphoma (DLBCL)",[27,28,29],"DLBCL - Diffuse Large B Cell Lymphoma","R-CHOP Chemotherapy","Pirtobrutinib","NOT_YET_RECRUITING","2026-08-04",{"date":33,"type":34},"2026-08-06","ACTUAL",{"date":36,"type":21},"2026-07-30",{"date":38,"type":21},"2029-04-30",{"name":40,"class":41},"Changzhou No.2 People's Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":42},"100650180","phase-2-pirtobrutinibpola-r-chp-for-newly-diagnosed-non-gcb-dlbcl-100650180","NCT07744724","Pirtobrutinib+Pola-R-CHP for Newly Diagnosed Non-GCB DLBCL","A Prospective, Multicenter Clinical Study of Pirtobrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone (Pola-R-CHP) for Newly Diagnosed Non-GCB Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Histologically confirmed Non-GCB DLBCL (per 2016 WHO diagnostic criteria);\n2. Whole-body PET\u002FCT performed within 28 days prior to study enrollment demonstrating at least one measurable lesion (per 2014 Lugano criteria);\n3. Age 18-65 years, with expected survival \\>3 months;\n4. No prior anti-lymphoma treatment;\n5. Signed written informed consent and ability to comply with protocol-required visits and procedures;\n6. ECOG performance status 0-2;\n7. Adequate organ and bone marrow function, defined as follows:\n\n   * Hematology: Absolute neutrophil count (ANC) ≥1×10⁹\u002FL, platelet count (PLT) ≥50×10⁹\u002FL, hemoglobin (HGB) ≥8.0 g\u002FdL; no granulocyte colony-stimulating factor, platelet transfusion, or red blood cell transfusion within 7 days prior to testing;\n   * Hepatic function: Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;\n   * Renal function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (CCR) ≥50 mL\u002Fmin;\n   * Cardiac function: NYHA Class III or below; left ventricular ejection fraction ≥50% by echocardiography;\n   * Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤ULN +10s, and prothrombin time (PT) ≤ULN +3s;\n8. Women of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Central nervous system involvement;\n2. History of hypersensitivity to the study drug, drugs of the same class, or excipients;\n3. Concurrent malignancy requiring treatment or intervention;\n4. Major surgery within 4 weeks prior to treatment (excluding vascular access catheter placement or biopsy);\n5. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures;\n6. Uncontrolled cardiac symptoms or disease, including: i. NYHA Class II or higher heart failure; ii. Unstable angina; iii. Myocardial infarction within 1 year; iv. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;\n7. Active bleeding;\n8. Active, uncontrolled systemic bacterial, viral, fungal, or parasitic infection (excluding onychomycosis), or other clinically significant active disease process that, in the investigator's opinion, renders the patient unsuitable for clinical trial participation;\n9. Known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome;\n10. Exclusion of patients with active chronic hepatitis B or active hepatitis C. Patients with positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening must undergo further HBV-DNA and HCV-RNA testing. Patients with stable hepatitis B (HBV-DNA \\\u003C2500 copies\u002FmL or 500 IU\u002FmL) on antiviral therapy and cured hepatitis C patients (below the limit of detection) may be enrolled;\n11. Definitive history of neurological or psychiatric disorder, including epilepsy or dementia;\n12. Pregnant or lactating women;\n13. Receipt of other investigational agents within 1 month prior to first dose;\n14. Any other factors that, in the investigator's opinion, may affect the evaluation of efficacy or safety in this study.","65 Years",{"count":52,"type":21},48,[24],"This is a single-arm, open-label, multicenter clinical study evaluating the efficacy and safety of pirtobrutinib combined with Pola-R-CHP in previously untreated Non-GCB DLBCL. PET\u002FCT assessment will be performed after 3 cycles of combination therapy. Patients achieving CR\u002FPR will continue treatment for another 3 cycles, while those with PD\u002FSD will be discontinued from the study. Patients achieving CR\u002FPR after 6 cycles of treatment will undergo follow-up with PET\u002FCT or contrast-enhanced CT every 3 months during the first year and every 6 months thereafter, until disease progression, death, withdrawal of informed consent, or study completion, whichever occurs first.",[27,29],{"date":33,"type":34},{"date":58,"type":21},"2026-07-31",{"date":60,"type":21},"2030-07-31",{"name":40,"class":41},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":42},"100624996","phase-2-thiotepa-in-combination-with-pirtobrutinib-a-btk-inhibitor-and-sintilimab-a-pd-1-inhibitor-for-frail-or-relapsedrefractory-primary-or-secondary-central-nervous-system-lymphoma-100624996","NCT07416890","Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","A Prospective, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Histopathologically confirmed relapsed primary central nervous system lymphoma (PCNSL) of B-cell lineage, or secondary central nervous system lymphoma (SCNSL) with a previously confirmed B-cell origin primary lesion but without evidence of active extracranial systemic involvement.\n2. The patients or their legal guardians provide voluntary written informed consent.\n3. Age\\>=18 years, both male and female.\n4. Karnofsky Performance Status (KPS) score\\>=40.\n5. Patients deemed unsuitable for methotrexate (MTX)-based systemic chemotherapy (\"unfit\"), including but not limited to: patients assessed as unsuitable for chemotherapy or frail according to a simplified Geriatric Assessment (sGA) criteria; patients with contraindications to MTX (e.g., renal insufficiency, serous cavity effusions, oral mucositis, etc.); or patients who refuse high-dose methotrexate (HD-MTX) chemotherapy.\n6. Life expectancy of greater than 3 months, as judged by the investigator.\n7. Patients with parenchymal lesions (\\>10\\*10mm ) on contrast-enhanced cranial MRI or those with leptomeningeal disease only, require cytological examination of cerebrospinal fluid (CSF) to confirm the presence of lymphoma cells and\u002For imaging findings consistent with CSF results. These assessments must be completed within 14 days prior to enrollment.\n8. If the patients have received prior anti-tumor therapy, all treatment-related non-hematologic toxicities must have recovered to Grade 1 or baseline (according to NCI CTCAE version 5.0, with the exception of alopecia).\n9. Bone marrow and organ function must meet the following criteria (without transfusion, G-CSF support, or corrective therapy within 14 days prior to informed consent):\n\n   1. Hematological: Absolute neutrophil count (ANC) \\>=1.5\\*10\\^9\u002FL (1500\u002Fmm\\^3), platelets \\>=75\\*10\\^9\u002FL, hemoglobin\\>=8 g\u002FdL (If bone marrow is involved, then platelets\\>=50\\*10\\^9\u002FL, ANC \\>=1.0\\*10\\^9\u002FL, and hemoglobin\\>=7 g\u002FdL are acceptable).\n   2. Hepatic: Total bilirubin \\\u003C=1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=2.5 × ULN.\n   3. Renal: Serum creatinine \\\u003C=1.5 × ULN or estimated creatinine clearance \\>=60 mL\u002Fmin.\n   4. Coagulation: INR \\\u003C=1.5 × ULN; PT and APTT \\\u003C=1.5 × ULN (unless the subject is receiving anticoagulant therapy and, at screening, PT and APTT are within the anticipated therapeutic range for the anticoagulant regimen).\n10. For the subjects of reproductive age women and fertile men, during the entire study period and within 3 months after the interruption of treatment, they must not have any conception plans with their partners. During the entire study period and within 3 months after the interruption of treatment, one of the following measures must be taken for effective contraception: abstinence, physical contraception (such as sterilization or condoms), and the use of hormonal contraceptive drugs (w hich must start at least 3 months before the first administration upon enrollment). For male subjects, sperm donation is prohibited from the start of treatment until 3 months after the cessation of treatment.\n11. Willingness and ability to undergo multiple MRI\u002FCT scans and an expected ability to undergo lumbar puncture.\n\nAbility to swallow oral medication without difficulty.\n\nExclusion Criteria:\n\n1. The patients with secondary central nervous system lymphoma (SCNSL) who have lesions outside the CNS and require systemic treatment.\n2. Received chemotherapy, radiotherapy, immunotherapy or antibody-based treatments for anti-tumor purposes within 4 weeks prior to the first administration (or within 5 half-lives), those who had used small molecule targeted drugs or traditional Chinese medicine with anti-tumor indications within 2 weeks, and those who had received monoclonal antibody conjugate drug treatments within 10 weeks.\n3. Receipt of any vaccine (including but not limited to vaccines for COVID-19, influenza, pneumonia, shingles, hepatitis B, etc.) within 4 weeks before taking the medicine for the first time.\n4. Concurrent enrollment in another interventional clinical study, or less than 4 weeks between the last dose of prior clinical trial treatment and the first dose in this study.\n5. Previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors is not excluded by default but requires benefit-risk assessment by the investigator. Subjects with a history of Grade \\>=3 immune-related adverse events (per NCI CTCAE v5.0) attributed to these agents are excluded.\n6. History of active bleeding within 4 weeks before the first dose; need for therapeutic anticoagulation during the study (e.g., warfarin or vitamin K antagonists); or any condition associated with elevated bleeding risk or coagulopathy per investigator judgment (e.g., high-risk esophageal varices, active ulcer disease).\n7. Treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers is required within 2 weeks before the first administration or during the study period.\n8. Concurrent presence of other malignant tumors requiring antineoplastic treatment.\n9. Having uncontrolled or significant cardiovascular diseases, including (but not limited to):\n\n   1. Any of the following conditions occurring within 6 months before the first administration: congestive heart failure with New York Heart Association class \\>= 3, myocardial infarction, unstable angina pectoris, arrhythmia requiring treatment at screening, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n   3. A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or a QTc interval \\> 470ms (for females) and \\> 450ms (for males);\n   4. Atrial fibrillation (EHRA class\\>= 2b);\n   5. Poorly controlled hypertension, which is deemed unsuitable for study participation by the investigator.\n10. Active uncontrolled infection requiring intravenous antimicrobial treatment.\n11. Patients with active chronic hepatitis B, active chronic hepatitis C, or syphilis. Patients who test positive for hepatitis B surface antigen or hepatitis C virus antibody during the screening period must undergo further tests for HBV DNA titer (which must not exceed 1000 IU\u002Fml) and HCV RNA (which must not exceed the lower detection limit of the assay) before being eligible for enrollment in the trial. Hepatitis B virus carriers, patients with hepatitis B stabilized after drug treatment, and patients with cured hepatitis C may be enrolled.\n12. Patients with a known history of HIV infection and\u002For AIDS.\n13. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or total gastrectomy.\n14. Autologous transplantation within 3 months, or organ or allogeneic stem cell transplantation within 6 months, before signing the informed consent form.\n15. Pregnancy or lactation.\n16. Stroke or intracranial hemorrhage within 6 months before first dosing, excluding post-surgical sequelae of intracranial bleeding.\n17. History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or similar conditions, deemed by the researcher as rendering the subject unsuitable for participation in the trial.\n18. Participants whom the investigator considers unsuitable for the study due to existing kidney, nerve\u002Fmental, liver, or endocrine diseases, or for any other reason judged by the researcher.\n19. Exclude patients with active autoimmune disease or a history of it, including but not limited to: immune-related neurologic disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, SLE, connective-tissue disease, scleroderma, inflammatory bowel disease (Crohn's or ulcerative colitis), hepatitis, TEN, Stevens-Johnson syndrome, antiphospholipid syndrome.\n\n    Note: allow subjects with vitiligo, eczema, type 1 diabetes, or endocrine disorders (e.g., thyroiditis on physiologic steroid replacement). Subjects with rheumatoid arthritis\u002Fother arthropathies, Sjögren's syndrome, controlled celiac disease, or psoriasis treated only topically, and those seropositive (ANA, anti-thyroid antibodies, etc.) must be assessed for target-organ involvement and need for systemic therapy; if neither is present, they may be enrolled.\n20. Major surgery within 28 days prior to the first study dose, as determined by the investigator.",{"count":70,"type":21},24,[24],"This is a prospective, single-Arm, phase II clinical study evaluating the efficacy and safety of thiotepa in combination with pirtobrutinib (a BTK Inhibitor) and sintilimab (a PD-1 Inhibitor) for frail or relapsed\u002Frefractory primary or secondary central nervous system lymphoma.It includes screening phase， induction therapy phase, and maintenance therapy phase.The screening period is defined as within 14 days prior to the first dose.Induction Treatment Phase: Enrolled subjects will receive a combination regimen of thiotepa, pirtobrutinib, and sintilimab. Treatment is administered in 21-day cycles for up to 6 cycles. Patients who achieve a disease response may proceed to consolidation therapy with either autologous hematopoietic stem cell transplantation or whole-brain radiotherapy at the investigator's discretion.Maintenance Treatment Phase: For patients who do not receive consolidation therapy with autologous transplantation or whole-brain radiotherapy, maintenance treatment with pirtobrutinib plus sintilimab will be initiated (for up to 1 year). Patients who receive any consolidation therapy will not proceed to maintenance treatment.Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. The trial will monitor patient survival data, objective response rate (ORR), and safety parameters.Upon discontinuation of study treatment or completion of the 1-year treatment period, subjects will enter the follow-up phase. During follow-up, radiographic assessments (contrast-enhanced CT of the involved site is recommended) will be performed according to the following schedule: every 3 months for the first 2 years, every 6 months from Year 3 to Year 5, and annually after 5 years, until the end of the follow-up period. For subjects who have not withdrawn consent, survival information (including date and cause of death, subsequent anti-tumor therapies, etc.) will be collected every 3 months via telephone and\u002For clinical visit.",[29,74,75],"Sintilimab","Central Nervous System Lymphoma",[77,78,79],"pirtobrutinib","sintilimab","central nervous system lymphoma","RECRUITING","2026-02-11",{"date":83,"type":34},"2026-02-18",{"date":85,"type":21},"2026-02-10",{"date":87,"type":21},"2030-08-05",{"name":89,"class":41},"Zhejiang Cancer Hospital"]