[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma-mantle-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma-mantle-cell":237},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,81,112,135,165,189,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100600733","phase-1-a-study-of-ly4152199-in-participants-with-previously-treated-b-cell-malignancies-baffrontier-1--100600733",false,"NCT07101328","A Study of LY4152199 in Participants With Previously Treated B-cell Malignancies (BAF_FRontier-1 )","BAF_FRontier-1, A First-in-Human, Phase 1 Trial to Assess Safety, Tolerability, and Preliminary Efficacy of LY4152199, a B-cell Activation Factor Receptor (BAFF-R) T-Cell Engager Bispecific Antibody in Adult Participants With Previously Treated B-cell Malignancies","BAF_FRontier-1","Inclusion Criteria:\n\n* Must have a diagnosis of either follicular lymphoma or diffuse large B-cell lymphoma.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Estimated life expectancy of greater than or equal to (≥)12 weeks as judged by the Investigator.\n* Participants with select tumor types must have measurable or assessable disease as defined below:\n\n  * Participants with lymphoma must have at least 1 bi-dimensionally measurable lesion or in the absence of measurable lymphadenopathy, documentation of bone marrow involvement.\n  * Participants with Waldenstrom macroglobulinemia (WM) must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than (\\>)2 times (×) upper limit of normal (ULN) based on local laboratory testing.\n* Must be able to comply with inpatient\u002Foutpatient treatment, laboratory monitoring, and required clinic visits for the duration of trial participation.\n* Must have adequate organ function.\n\nPhase 1 Dose Escalation (Cohort A) Participants - Must have histologically confirmed relapsed\u002Frefractory B-cell malignancy.\n\nPhase 1 Dose Optimization (Cohort B) Participants\n\n\\- Must have histologically confirmed relapsed\u002Frefractory diffuse large B-cell lymphoma (DLBCL) de novo or transformed from follicular lymphoma (FL).\n\nExclusion Criteria:\n\nAll Participants\n\n* Known or suspected peripheral blood involvement by malignant cells with an absolute lymphocyte count of greater than or equal to (≥) 5000 cells per microliter (μL).\n* Known or suspected central nervous system (CNS) involvement by systemic lymphoma.\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade 2 at the time of starting trial treatment except for alopecia.\n* Autologous stem cell transplantation within 100 days of this study for post autologous transplant individuals.\n* Residual symptoms of neurotoxicity or cytopenias from prior chimeric antigen receptor T-cell therapy (CAR-T) or bispecifics. Exception: Cytopenia related to prior CAR-T or bispecifics allowed if they meet the adequate organ function criteria.\n* Known or suspected history of macrophage activation syndrome or hemophagocytic lymphohistiocytosis (HLH).\n* Active second malignancies, unless in remission, with life expectancy greater than 2 years with Sponsor approval.\n* History of autoimmune disease\n* Significant cardiovascular disease\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection (except for fungal nail infection), or other clinically significant active disease process\n* Vaccination with a live vaccine within 4 weeks prior to signing informed consent form (ICF).\n* Have current or had a history of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).\n* Prior treatment with B-cell activating factor receptor (BAFF-R) directed therapies (e.g., monoclonal antibody, CAR-T or bispecific antibody).\n* Pregnant and\u002For planning to breastfeed during the trial or within 90 days of the last dose of study intervention.\n* Known hypersensitivity to any component or excipient of LY4152199.","ALL","18 Years",{"count":20,"type":21},215,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to find the best dose of the drug and measure the safety and efficacy of LY4152199 in participants with previously treated B-cell malignancies. Participants will have the option to continue taking LY4152199 until the study ends.",[27,28,29,30,31,32,33],"Lymphoma, Non-Hodgkin","B-cell Lymphoma","Lymphoma, Large B-Cell, Diffuse","Lymphoma, Follicular","Lymphoma, B-cell Marginal Zone","Waldenstrom Macroglobulinemia","Lymphoma, Mantle Cell",[35,36],"B- cell activating factor receptor (BAFFR)","Bispecific antibody","NOT_YET_RECRUITING","2026-06-19",{"date":40,"type":41},"2026-06-23","ACTUAL",{"date":43,"type":21},"2026-06",{"date":45,"type":21},"2029-09",{"name":47,"class":48},"Eli Lilly and Company","INDUSTRY",50,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100629569","a-study-to-evaluate-mtm-h-001-injection-in-adult-participants-with-relapsed-or-refractory-b-cell-malignancies-100629569","NCT07476378","A Study to Evaluate MTM-H-001 Injection in Adult Participants With Relapsed or Refractory B-cell Malignancies","An Open-label, Single-arm, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in the Treatment of Adult Participants With Relapsed or Refractory B-cell Malignancies (Archonc-001)","Archonc-001","Inclusion Criteria:\n\n1. Male or female, aged 18 - 75 years old (inclusive);\n2. The participant or his\u002Fher legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study;\n3. Participants with histopathologically and immunohistochemically confirmed Non-Hodgkin B-cell Lymphoma (B-NHL) according to the 2016 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues (CLL\u002FSLL diagnosed in accordance with 2018 iwCLL criteria)\n4. Relapsed or refractory disease after receiving at least two prior lines of standard therapy, or relapsed or refractory disease after receiving autologous hematopoietic stem cell transplant (ASCT) (if applicable).\n5. Adequate major organ function, defined as meeting the following criteria:\n\n   1. Hematology: Hemoglobin (Hb) ≥80 g\u002FL; absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL; and platelet count (PLT) ≥75×10\\^9\u002FL;\n   2. Coagulation: International Normalized Ratio (INR) ≤1.5×Upper Limit of Normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;\n   3. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×Upper Limit of Normal (ULN);\n   4. Serum Total Bilirubin (TBIL) ≤1.5×ULN (except for participants with documented Gilbert's syndrome);\n   5. Blood creatinine (Cre) ≤1.5×ULN, or calculated creatinine clearance (Ccr) ≥50 mL\u002Fmin (using the Cockcroft-Gault formula);\n   6. Cardiac function: Good hemodynamic stability, Left Ventricular Ejection Fraction (LVEF) ≥50%;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;\n7. Expected survival \\>3 months;\n8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.\n\nExclusion Criteria:\n\n1. B-NHL participants with a history of Richter's transformation of chronic lymphocytic leukemia (CLL).\n2. Primary central nervous system (CNS) lymphoma, or malignant tumors involving the CNS.\n3. Burkitt's lymphoma\u002Fleukemia, primary mediastinal large B-cell lymphoma (LBCL).\n4. Known history of other malignancies within the past 5 years, excluding cured localized tumors (including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ, etc.);\n5. Active hepatitis B virus (HBV) infection;\n6. Active hepatitis C virus (HCV) infection;\n7. Active human immunodeficiency virus (HIV) infection or a past history of HIV infection;\n8. Uncontrolled active infection requiring intravenous treatment within one week prior to the first dose;\n9. Corrected QT interval using Fridericia (QTcF) is ≥450 ms (male) or ≥470 ms (female) according to the electrocardiography (ECG) examination results at screening;\n10. Currently experiencing or having experienced within the past 6 months any of the following:\n\n    1. Congestive heart failure (New York Heart Association \\[NYHA\\] Class III-IV);\n    2. Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg with medication treatment;\n    3. Myocardial infarction, clinically significant arrhythmias, unstable angina, Torsades de Pointes, left bundle branch block or bifascicular block, coronary\u002Fperipheral artery bypass grafting, congenital long QT syndrome;\n    4. Cerebrovascular accident, transient ischaemic attack;\n    5. Symptomatic pulmonary embolism;\n11. History of any mental disorders (e.g., schizophrenia, bipolar disorder, eating disorders, major depression, or anxiety) as reported by the participant or documented in medical records;\n12. Pregnant or breastfeeding women.","75 Years",{"count":60,"type":21},69,[62],"NA","This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with relapsed\u002Frefractory (R\u002FR) B-cell malignancies.",[65,30,66,67,68,69],"Lymphoma, Large B-Cell, Diffuse (DLBCL)","Lymphoma, Mantle-Cell","Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Lymphoma, B-Cell, Marginal Zone","Transformed Follicular Lymphoma (TFL)","2026-03-12",{"date":72,"type":41},"2026-03-17",{"date":74,"type":21},"2026-03",{"date":76,"type":21},"2028-06",{"name":78,"class":79},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100559013","phase-2-phase-ii-study-of-glofitamab-with-venetoclax---zanubrutinib-in-high-risk-mantle-cell-lymphoma-100559013","NCT06558604","Phase II Study of Glofitamab With Venetoclax +\u002F- Zanubrutinib in High-risk Mantle-cell Lymphoma","A Phase II, Multicenter, Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed\u002FRefractory High-risk Mantle-cell Lymphoma","GLOASIS","Inclusion Criteria:\n\nIn cohort A, subject must meet the following inclusion criteria:\n\n1. Subject must be primary refractory or in progression within 24 months from initiation of first line treatment (POD24 defined as time between D1C1 of the first treatment line and ICF signature)) (including an anti-CD20 combined with chemotherapy). Subject previously exposed to BTK inhibitor at first line is eligible. Subject in failure of CAR-T cell first line is eligible.\n2. Primary refractory subjects (ie with a progressive disease) to the BTKi and Venetoclax combination will not be eligible.\n\n   In cohort B, subject must meet the following inclusion criterion:\n3. Subject must be R\u002FR MCL and refractory or progressive to a BTK inhibitor given in a previous line of treatment (the number of treatment lines is not limited). If first progression, time from diagnosis (defined as D1C1 of the first treatment line) to inclusion (defined as the date of ICF signature) must be superior to 24 months.\n4. Subject previously exposed to Bcl-2 therapy and\u002For relapsing post CAR-T cell therapy is eligible, except if they presented a progressive disease under BTKi and Venetoclax combination.\n\n   In cohort C, subject must meet the following inclusion criteria:\n5. Subject not previously treated for mantle cell lymphoma.\n6. Subject at high risk of relapse presenting at least two of the following risk factors:\n\n   1. TP53 mutation, del17p, or p53 expression (IHC) \\> 50%,\n   2. blastoïd variant,\n   3. complex karyotype,\n   4. c-myc rearrangement (FISH),\n   5. Ki67≥30%,\n   6. high MIPI score, (or MIPI simplified)\n   7. high MIPI-combined score ((ie high MIPI score + Ki67≥30%): this criterion alone is sufficient.\n\n   Subject must meet all of the following additional criteria to be enrolled in the study for cohort A, B and C:\n7. Subject is ≥ 18 years and \\\u003C 80 years of age at the time of signing the informed consent form (ICF).\n8. Subject understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted.\n9. Subject with histologically proven mantle cell lymphoma (latest WHO classification). The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation. Diagnostic tissue should be available for central pathology review and ancillary molecular studies.\n10. Bi-dimensionally measurable disease defined by at least one single node or tumor lesion ≥ 1.5 cm assessed by CT scan, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on CT scan, and\u002For clinical examination.\n11. Stage II-IV disease,\n12. ECOG performance status of 0, 1, 2.\n13. Life expectancy of more than 3 months.\n14. Adequate renal function as demonstrated by a creatinine clearance \\> 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or MDRD formula.\n15. Adequate hepatic function per local laboratory reference range as follow (unless if due to lymphoma involvement):\n\n    1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5x upper limit of normal (ULN)\n    2. Bilirubin \\\u003C 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin. in which case total bilirubin should be \\\u003C 3 x ULN).\n16. Women of childbearing potential (WOCBP) (refer to section 14.7 for more details) must have negative results for highly effective urine\u002Fserum pregnancy test 10-14 days prior to Day 1 of Cycle 1 and within 24 hours prior to day 1 Cycle 1 prior to initiating study treatment and agree to abstain from becoming pregnant or breastfeeding during study participation and until at least 18 months after C1 with Obinutuzumab, or 3 months after the final dose of tocilizumab (if applicable), or 2 months after the final dose of Glofitamab, or or 1 month after the final dose of Zanubrutinib (if applicable), or 30 days after the final dose of Venetoclax, whichever is longer. WOCBP agree to remain abstinent (from heterosexual intercourse) or use two methods of contraception, and to refrain from donating eggs, during the treatment period and for at least 18 months after the final dose of Obinutuzumab, 3 months after the final dose of tocilizumab (if applicable), 2 months after the final dose of Glofitamab, 1 month after the final dose of Zanubrutinib (if applicable), and 30 days after the final dose of Venetoclax (refer to section 14.6).\n17. Men of reproductive potential (refer to section 14.6 for more details) agree to remain abstinent (from heterosexual intercourse) or use effective methods of birth control with a non-pregnant female partner of childbearing potential or a pregnant female partner and to refrain from donating sperm, during the treatment period and for at least 3 months after the final dose of Obinutuzumab, 2 months after the final dose of Glofitamab, 2 months after the final dose tocilizumab (if applicable), 30 days after the final dose of Venetoclax, 1 week after the final dose of Zanubrutinib (if applicable).\n18. Adequate bone marrow function as defined by:\n\n    1. Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3, except for subjects with bone marrow involvement in which ANC must be ≥ 500\u002Fmm3.\n    2. Platelet ≥ 75,000\u002Fmm3, except for subjects with bone marrow involvement in which the platelet count must be ≥ 50,000\u002Fmm3 .\n19. Subject covered by any social security system (France).\n20. Subject who understands and speaks one of the country official languages unless local regulation authorizes independent translators.\n21. Subject with a SARS-COV2 vaccination status in line with local National guidelines\u002Frecommendations (COSV, ANRS MIE).\n22. Subject must be willing and able to comply with protocol-mandated hospitalization upon administration of the first two doses of Glofitamab. Subject must also be willing to comply with all study-related procedures.\n23. Adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (hematological toxicities excepted)\n\n    \\-\n\nExclusion Criteria:\n\nSubject who meets any of the following criteria will be excluded from enrollment in the study study for cohort A, B and C:\n\n1. Proven or previously known CD20 negative status on FFPE IHC at time of MCL relapse or diagnosis.\n2. For subjects in Cohort A and B: previously refractory to treatment by BTK inhibitor and Bcl-2 therapy combination.\n3. Any prior therapy with a bispecific antibody targeting CD3 and CD20.\n4. Current or past history of central nervous system or meningeal involvement by lymphoma.\n5. Use of any standard or experimental anti-cancer drug therapy including biological agents (e.g. monoclonal antibodies) within 30 days of the start (Day 1) of study treatment, except for BTKi for subjects included in cohort B, that can be pursued until C1D1. and except for topical treatment or hormone treatment if criterion 33 is respected. Corticosteroid treatment ≤ 1 mg\u002Fkg\u002Fday prednisone or equivalent is allowed within 2 weeks prior to Obinutuzumab infusion.\n6. LVEF \\\u003C 50% as determined by echocardiography or isotopic method.\n7. Clinically significant cardiovascular disease such as uncontrolled, unstable or symptomatic arrhythmias, unstable angina, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class III (moderate) or Class IV(severe) cardiac disease as defined by the New York Heart Association Functional Classification or Objective Assessment Class C or D cardiac disease. Heart rate-corrected QT interval \\> 480 milliseconds based on Fridericia's formula.; History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place; Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements, at screening, showing systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg and\u002For uncontrolled hypertension with systolic blood pressure\\>140mmHg despite a well conduct hypertensive treatment for at least 6 months\n8. Hemoglobin level \\\u003C 8g\u002FdL; Absolute Neutrophil count \\\u003C1 G\u002FL (\\\u003C0,5G\u002FL if related to lymphoma); Platelets \\\u003C 75 G\u002FL (\\\u003C 50 G\u002FL if related to lymphoma),\n9. Major surgery within 28 days before screening.\n10. Require the use of anticoagulation by warfarin or equivalent vitamin K antagonists (e.g., phenprocoumone)\n11. Requires treatment with a moderate or a strong CYP3A inhibitor or inducer..\n12. Vaccinated with live, attenuated vaccines within 4 weeks of enrollment (except COVID vaccine) or anticipation that such a live attenuated vaccine will be required during the study.\n13. Known hypersensitivity to active substances or to any of the excipients. Or Contraindication to any study treatments.\n14. Known allergy to all xanthine oxidase inhibitors or rasburicase.\n15. Previously documented G6DP deficiency.\n16. Severe prior reactions to anti CD20 monoclonal antibodies or prior significant toxicity (other than thrombocytopenia) with Bcl-2 inhibitor.\n17. Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment.\n18. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n19. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.\n20. Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease: or intracranial hemorrhage: Subjects with a history of stroke or intracranial hemorrhage who have not experienced a stroke or transient ischemic attack or intracranial hemorrhage within the past 2 years and have no residual neurologic deficits, as judged by the investigator, are allowed.\n21. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment.\n22. Known Human Immunodeficiency Virus (HIV), for subjects with unknown HIV status, HIV testing will be performed at screening if required by local regulations.\n23. Positive test results for hepatitis C virus (HCV) antibody: Subjects who are positive for HCV antibody are eligible only if PCR is negative for HCV RNA.\n24. Positive test results for hepatitis B virus (HBV) infection (defined as positive HbsAg serology) Subjects with occult or prior HBV infection (defined as negative HbsAg and positive HbcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy.\n25. Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.\n26. Documented SARS-CoV-2 infection within 6 months of first study treatment (Cycle 1 Day 1): Subjects may be eligible if they have no persistent respiratory symptoms, no evidence of lung infiltrates on chest CT, and have a negative PCR during the first 30 days prior to first study treatment (Cycle 1 Day 1)\n27. Suspected or latent tuberculosis (confirmed by positive interferon-γ release assay)\n28. Known or suspected chronic active Epstein-Barr viral infection.\n29. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study treatments, or put the study outcomes at undue risk.\n30. Prior allogenic SCT is allowed if no active GVHD and no active immune-suppressive treatment (to be discussed with the medical monitor).\n31. Active autoimmune disease requiring treatment:\n\n    1. Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible.\n    2. Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    3. Subjects with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded.\n    4. Subjects with a history of immune thrombocytopenic purpura, autoimmune hemolytic anaemia, Guillain-Barré syndrome, myasthenia gravis, myositis rheumatoid arthritis, vasculitis, or other autoimmune diseases will be excluded unless they have not required systemic therapy in the last 12 months.\n32. Subject with history of confirmed progressive multifocal leukoencephalopathy (PML)\n33. Active malignancy other than the one treated in this research. Prior history of malignancies unless the subject has been free of the disease for ≥ 2 years. However, subjects with the following history\u002Fconcurrent conditions are allowed:\n\n    1. Basal or squamous cell carcinoma of the skin\n    2. Carcinoma in situ of the cervix\n    3. Carcinoma in situ of the breast\n    4. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis \\[TNM\\] clinical staging system.\n34. Pregnant, planning to become pregnant or lactating WOCBP.\n35. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation or understanding of study requirements (according to the investigator's decision).\n36. Severe or debilitating pulmonary disease, history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases, including but not limited to pulmonary fibrosis and acute lung diseases.\n37. Known or suspected history of HLH unless related to lymphoma.\n38. Clinically significant history of cirrhotic liver disease, ongoing, drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.\n39. INR or PT \\> 1.5 x ULN, or Quick percentage \\\u003C 70% (if Quick percentage used in lieu of time-based units for reporting PT), in the absence of therapeutic anticoagulation.\n40. aPTT \\>1.5 x ULN in the absence of therapeutic anticoagulation or a lupus anticoagulant.\n41. Prior solid organ transplantation.\n42. Person deprived of his\u002Fher liberty by a judicial or administrative decision.\n43. Person hospitalized without consent.\n44. Adult person under legal protection.\n\nNB: for 42, 43, 44 if there is an individual benefit for such subjects, an Ethics Committee will have to be informed case by case.\n\n\\-","79 Years",{"count":91,"type":21},100,[93],"PHASE2","This open-label, multicenter, three cohorts, phase II study is designed to assess a combination of Zanubrutinib\u002FVenetoclax\u002FGlofitamab or Venetoclax\u002FGlofitamab in high-risk subjects with either first line or R\u002FR Mantle Cell Lymphoma (MCL).\n\nThree independent cohorts will be run:\n\n* Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment (POD 24).\n* Cohort B will be open for subjects with R\u002FR MCL and refractory or progressive to a BTK inhibitor given previously (\\>24 months if first line).\n* Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features.",[66],[97,98,99,100],"POD24","BTKI failure","High risk","18 to 79 years","RECRUITING","2026-02-09",{"date":104,"type":41},"2026-02-11",{"date":106,"type":41},"2025-02-21",{"date":108,"type":21},"2032-03",{"name":110,"class":79},"The Lymphoma Academic Research Organisation",16,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100489946","phase-1-a-study-of-pep07-checkpoint-kinase-1-inhibitor-in-patients-with-advanced-cancer-100489946","NCT05659732","A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer","A Phase 1b Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer","Inclusion Criteria:\n\n1. Must be ≥ 18 years of age.\n2. Must have histological or cytological confirmation advanced hematologic malignancy including:\n\n   * Relapsed or refractory AML (by the 5th edition of World Health Organization \\[WHO\\] classification of Hematolymphoid tumors)\n   * OR Relapsed or refractory MCL and have received at least two prior lines of treatment, including chemoimmunotherapy and BTKi and at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma.\n3. Must have Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.\n4. Must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.\n5. Must have adequate liver function as demonstrated by:\n\n   * aspartate aminotransferase (AST) ≤ 2.5 × ULN\n   * alanine aminotransferase (ALT) ≤ 2.5 × ULN\n   * bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement. Patients with Gilbert's Syndrome may have had a bilirubin \\> 1.5 × ULN per discussion between the PI or designee and sponsor)\n6. Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram.\n7. Previous AEs have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0.\n8. Female patients with reproductive potential must have a negative serum pregnancy test 7 days prior to the administration of PEP07.\n9. Patients will be required to have a Covid negative test either via reverse transcriptase polymerase chain reaction (RTPCR) or a rapid antigen test (RAT) test on Day -7\u002FDay 1.\n10. Provision of signed and dated informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females\n2. Females of childbearing potential and males whose partners are of childbearing potential who do not agree to the use of 2 forms of highly effective contraception during the treatment period and for 120 days after the last dose of PEP07.\n3. Patients who have received anti-cancer therapy including chemotherapy, radiotherapy, hormonal, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter), or immunotherapy within 30 days prior to the first dose of PEP07. Patients who have received hydroxyurea or dexamethasone at any time prior to the start of study treatment is an exception to this criterion.\n4. Patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) within 60 days of PEP07 treatment.\n5. Patients who have received strong or moderate CYP3A4 inhibitors or inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within 5 half-lives or 7 days (whichever is the shortest) prior to the initiation of study treatment.\n6. Viral infection with HIV or viral hepatitis type B or C which require antiviral therapy and\u002For have positive serology test of hepatitis B surface antigen \\[HBsAg (+)\\] with HBV DNA ≥ 1000 IU\u002FmL, or hepatitis C virus antibody \\[anti-HCV Ab (+)\\] with HCV RNA (+). If a patient is HBsAg (+) then HBV DNA needs to be tested. If a patient is anti-HCV Ab (+) then the patient needs to be followed for HCV RNA (-) to be enrolled.\n7. Uncontrolled systemic infection \u002For requiring isolation.\n8. Patients with previous history of other malignant diseases within the last 5 years (other than adequately treated non-melanotic skin cancer, in-situ carcinoma of the uterine cervix or myelodysplastic syndromes).\n9. Patients with ongoing ≥ Grade 2 (CTCAE v5.0) toxicity (except alopecia and hot flashes) related to previous treatment.\n10. Patients with baseline QTc interval \\> 450 msec (i.e., CTCAE Grade ≥ 2) at screening (within 28 days prior to 1st dose of PEP07, mean of triplicate readings within approximately 5 minutes).\n11. Patients with cardiovascular disability status of New York Heart Association (NYHA) ≥ Class III, left ventricular ejection fraction \\\u003C 45 % at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment.\n12. Patients who have undergone any major surgery within 3 weeks prior to first study drug administration after enrollment.\n13. Patients with known active central nervous system (CNS) or leptomeningeal involvement.\n14. Patients who have had any of the following within 6 months prior to first administration of PEP07 after enrollment: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or seizure disorder.\n15. Have a history of hypersensitivity reactions or allergic reactions to PEP07 excipients and components.\n16. Patients with other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results.\n17. Others who are ineligible to participate in this clinical study as determined by the PI or designee.",{"count":120,"type":21},32,[24],"The goal of this clinical trial is\n\n* To assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in patients with Acute Myeloid Leukemia (AML) and Mantle Cell Lymphoma (MCL).\n* To determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of PEP07 monotherapy.\n\nParticipants will receive PEP07 administered orally once daily (QD) for 2 consecutive days and 5 days off, every week for 4 weeks until disease progression, intolerable toxicity, confirmed pregnancy, death, consent withdrawal, HSCT or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.",[124,66],"Acute Myeloid Leukemia","2025-07-28",{"date":127,"type":41},"2025-07-31",{"date":129,"type":41},"2023-07-17",{"date":131,"type":21},"2026-12-31",{"name":133,"class":48},"PharmaEngine",5,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":142,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100519619","phase-1-a-phase-iii-trial-of-aleta-001-for-the-treatment-of-participants-with-b-cell-malignancies-100519619","NCT06045910","A Phase I\u002FII Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies","A Cancer Research UK Phase I\u002FII Trial of ALETA-001 in Participants Who Have Received an Anti-CD19 CAR T-Cell Therapy for the Treatment of B-cell Malignancies","Inclusion Criteria:\n\nFor all participants\n\nCriteria to be met prior to enrolment in the trial:\n\n* Aged 16 years or over.\n* Written (signed and dated) informed consent and be capable of co-operating with ALETA-001 administration and follow-up.\n* Confirmed diagnosis of B-cell NHL according to World Health Organization (WHO) 2016 criteria.\n* Eastern Cooperative Oncology Group performance status of 0, 1 or 2.\n* Biochemical indices within protocol specified ranges.\n\nCohort Specific Inclusion criteria (for Phase I Cohorts A \\& B) Criteria to be met prior to enrolment in the trial.\n\n* Histologically confirmed diagnosis of relapsed\u002Frefractory LBCL or MCL.\n* Have received an approved anti-CD19 CAR T-cell therapy.\n* Objectively evaluable or measurable disease at 4 weeks (±1 week) post CAR T, which demonstrates:\n\n  * inadequate or incomplete response (PR or SD), or\n  * PD if there is a reasonable expectation of deriving benefit from trial treatment, or\n  * initial response followed by relapse within 9 months assessed according to Lugano Criteria.\n* Haematological indices within protocol specified ranges.\n\nCohort Specific Inclusion criteria (for Phase I Cohorts C \\& D) Criteria to be met prior to lymphodepleting chemotherapy for CAR T therapy.\n\n* Histologically confirmed diagnosis of relapsed\u002Frefractory LBCL or MCL.\n* Approved by the UK national CAR T Clinical Panel (NCCP) to receive an approved anti-CD19 CAR T-cell therapy.\n* Haematological indices within protocol specified ranges.\n* Adequate cardiac function within protocol specified ranges with no clinical symptoms or signs of heart failure.\n* Resting O2 saturation of ≥92% on room air.\n\nEligibility for participants in Phase II of the trial will depend on timing of administration of ALETA-001 which will be recommended by the Safety Review Committee (SRC).\n\nExclusion Criteria for all participants:\n\n* Active or previous malignancies of other types that, in the opinion of the Investigator, should exclude the participant. Exceptions include adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin and patients with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or who require only hormonal therapy and have had normal prostate specific antigen for \\>1 year prior to the start of therapy. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for 2 years or more and are deemed at negligible risk for recurrence, are eligible for the trial.\n* Any ongoing toxic manifestation of previous anti-cancer treatment that, in the opinion of the Investigator, should exclude the participant.\n* Ongoing need for systemic immunosuppressive therapy other than replacement dose of corticosteroids. Intermittent topical, inhaled or intranasal corticosteroids are permitted.\n* Presence of active infections and\u002F or inflammatory disease requiring active management.\n* Documented current central nervous system involvement by lymphoma.\n* Women of childbearing potential (or are already pregnant or lactating) unless willing to adhere to protocol-defined contraceptive requirements.\n* Male patients with partners of childbearing potential unless willing to adhere to protocol-defined contraceptive requirements.\n* Major thoracic or abdominal surgery from which the participant has not yet recovered.\n* At high medical risk because of non-malignant systemic disease including active uncontrolled infection.\n* Hypersensitivity to any of the ingredients\u002Fexcipients in ALETA-001.\n* Participation in another interventional clinical trial, whilst taking part in this trial of ALETA-001. Participation in an observational trial or interventional clinical trial that does not involve administration of an IMP and that would not place an unacceptable burden on the participant, in the opinion of the Investigator and CDD, would be acceptable.\n* Participants with any congenital or acquired immunodeficiency syndrome or who are receiving immunosuppressive therapy (including any dose of systemic corticosteroids), or who are immunosuppressed post organ transplant. However, participants receiving inhaled corticosteroids and participants with a history of allergy (other than anaphylaxis) are eligible, as are participants with a history of autoimmune disease.\n* Any other condition that, in the Investigator's opinion, would mean that the trial is not in the best interests of the participant.\n* Concurrent radiotherapy (except for palliative reasons).\n\nCohort specific exclusion criteria prior to enrolment in the trial (for Phase I\n\nCohorts A \\& B):\n\n* Participants who have received any other systemic anti-cancer treatment post-CAR T.\n* Potential participants who experienced any of the following because of the initial CAR T treatment:\n\n  * Grade 4 CRS or ICANS post CAR T infusion.\n  * Grade ≥3 CRS or ICANS persisting beyond 7 days despite optimal therapy.\n  * Any Grade ≥1 CRS or ICANS must have fully resolved.\n* Any Grade ≥3 organ toxicity (other than haematologic toxicity) following CAR T infusion must have improved to Grade ≤2 for at least 48 hours prior to ALETA-001 infusion.\n\nCohort specific exclusion criteria prior to ALETA-001 infusion between Day 10-18 post CAR T-cell infusion (for Phase I Cohorts C \\& D):\n\n* Grade 4 CRS or ICANS post CAR T infusion.\n* Grade ≥3 CRS or ICANS persisting beyond 7 days despite optimal therapy.\n* Any Grade ≥2 CRS or ICANS must have improved to Grade ≤1 for at least 48 hours prior to ALETA-001 infusion.\n* ECOG performance status ≥3.\n* Any Grade ≥3 organ toxicity (other than haematologic toxicity) following CAR T infusion must have improved to Grade ≤2 for at least 48 hours prior to ALETA-001 infusion.\n* Any unresolved serious active infection which in the opinion of the Investigator precludes ALETA-001 infusion (ongoing need for IV antimicrobial therapy per se is not an exclusion).","16 Years",{"count":144,"type":21},84,[24,93],"This is a Phase I\u002FII multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability, timing of administration and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in participants with B-cell malignancies post CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 and timing of administration will be evaluated in Phase I in order to define a recommended dosing level and time of administration for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.",[27,29,66,30,148,149],"Lymphoma, B-Cell","Large B-cell Lymphoma",[151,152,153,154,155],"Neoplasms","Immunotherapy, Adoptive","Receptors, Chimeric Antigen","Receptors, Antigen, T-Cell","Antigens, CD19","2025-07-24",{"date":125,"type":41},{"date":159,"type":41},"2024-02-07",{"date":161,"type":21},"2029-12-21",{"name":163,"class":79},"Cancer Research UK",7,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100548916","phase-2-this-is-a-phase-ii-open-label-multicentre-study-of-zanubrutinib-containing-regimens-in-patients-with-newly-diagnosed-mantle-cell-lymphoma-100548916","NCT06427213","This is a Phase II, Open-label, Multicentre Study of Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma","A Study of the Zanubrutinib-containing Regimens in Patients With Newly Diagnosed Mantle Cell Lymphoma","Inclusion Criteria:\n\n1. Voluntary participation in clinical study; Fully understand and understand the study and sign the informed consent form (ICF);Willingness to follow and ability to complete all study steps\n2. Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)，previous untreatment for mantle-cell lymphoma (MCL)\n3. The elderly group ≥65 years old;The young group was ≥18 years old and \\\u003C 65 years old.\n4. ECOG Performance Status 0-3\n5. Life expectancy of at least 3 months\n6. At least one evaluable lesion according to 2014 Lugano criteria;\n7. Proper functioning of the major organs, no major heart, lung, liver, kidney, or immunodeficiency (no blood transfusion, granulocyte colony-stimulating factor, or other medical support within 7 days before starting the study) :Hemoglobin (HB)≥60 g\u002FL;Absolute neutrophil count(ANC)≥0.5×10\\^9\u002FL;Platelet count（PLT）≥50×10\\^9\u002FL;AST and ALT ≤ 2.5 x ULN；Total bilirubin ≤ 1.5 times the ULN;Ccr≥40ml\u002Fmin（Cockcroft-Gault ）；Left Ventricular Ejection Fraction (LVEF) ≥ 50%\n\nExclusion Criteria:\n\n1. The presence of other tumors could affect the study medication or interfere with the results;\n2. Patients require treatment with strong or moderate CYP3A inhibitors;\n3. Pregnant or lactating women;\n4. Known to be allergic to the test drug ingredients;\n5. Subjects of childbearing potential who are unwilling to use highly effective contraceptive methods;\n6. Live vaccination was administered within 28 days prior to treatment\n7. Known human immunodeficiency virus (HIV) infection or suggested active B or C infection The following serologic status of hepatitis C virus infection: 1) Hepatitis B virus (HBV) DNA positive. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) seropositive if HBV DNA is undetectable and willing to accept Monthly surveillance for HBV reactivation was eligible. 2) Hepatitis C virus (HCV) antibody positive. For patients with HCV antibodies present, if undetectable HCV RNA, can be included;\n8. Severe coagulopathy and serious impairment of heart, brain, lung, liver, kidney and other organs\n9. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;\n10. Any risk that is considered by the investigator to be likely to affect the safety of the subjects or to pose a risk to the study And vital diseases, medical conditions, or organ system insufficiency.",{"count":173,"type":21},41,[93],"This is a phase II, open-label, multicentre study of Zanubrutinib-containing regimens in patients with newly diagnosed mantle cell lymphoma.",[66,27],[178],"Zanubrutinib","2024-05-19",{"date":181,"type":41},"2024-05-23",{"date":183,"type":21},"2024-05-20",{"date":185,"type":21},"2029-12-30",{"name":187,"class":188},"Henan Cancer Hospital","OTHER_GOV",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":80},"100526562","phase-2-a-study-of-the-zanubrutinib-given-in-combination-with-bendamustine-and-rituximab-in-elderly-or-tp53-alterations-or-chemotherapy-intolerance-patients-with-newly-diagnosed-mantle-cell-lymphoma-100526562","NCT06136351","A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma","Inclusion Criteria:\n\n* 18 years\n\n  * Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)\n  * FISH with del(17p)\u002FTP53 mutation or ≥65 years; or\\\u003C65 years but chemotherapy intolerance;\n  * Life expectancy of \\> 3 months (in the opinion of the investigator);\n  * Creatinine Clearance Rate (CCR) ≥ 50 mL\u002Fmin or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL\u002F(min·1.73 m\\^2);\n  * International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;\n  * Left Ventricular Ejection Fraction (LVEF) ≥ 50%;\n  * Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Known Hepatitis B Virus (HBV) and\u002For Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \\> detectable limit);\n* With acquired or congenital immunodeficiency;\n* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \\\u003C 50%;\n* Known to be allergic to the test drug ingredients;\n* Diagnosed with or being treated for malignancy other than lymphoma;\n* With severe infection;\n* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;\n* Deemed unsuitable for the group.",{"count":196,"type":21},23,[93],"The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.",[66],"2023-11-24",{"date":202,"type":41},"2023-11-29",{"date":204,"type":41},"2023-11-15",{"date":206,"type":21},"2027-11-01",{"name":208,"class":79},"Ruijin Hospital",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":164},"100432591","phase-2-study-of-pv-in-combination-with-bendamustine-and-rituximab-for-patients-with-rr-mcl-100432591","NCT04913103","Study of PV in Combination With Bendamustine and Rituximab for Patients With R\u002FR MCL","A Phase II, Open-label Study of Polatuzumab-vedotin (PV) in Combination With Bendamustine and Rituximab for Patients With Mantle Cell Lymphoma, Who Relapse After Previous Therapy With Bruton Tyrosine Kinase Inhibitor","CLSGMCLPOLA","Inclusion Criteria:\n\n* Signed written Informed Consent Form\n* Adult patients with relapsed or refractory MCL after failure of BTK inhibitor-containing therapy (e.g. ibrutinib, acalabrutinib, zanubrutinib)\n* Patients previously treated with bendamustine are eligible for the study treatment, in the case they had achieved objective response (CR or PR) and the last dose of bendamustine was administered ≥ 1 year before the estimated study treatment initiation date (C1D1)\n* Tumor tissue at the lymphoma relapse after failure of BTK inhibitor. In case that a re-biopsy is not possible (e.g. urgent need to start study treatment), archival tissue blocks may be used to confirm the diagnosis\n* Bone marrow examination by standard trephine biopsy including flow cytometry analysis within 8 weeks before study entry\n* Age 18-80 years at the time of signing Informed Consent Form\n* ECOG Performance Status of 0, 1, or 2\n* Life expectancy ≥ 2 months\n* Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by MCL per the investigator), defined as follows:\n\n  * Hemoglobin ≥ 80g\u002FL\n  * ANC ≥ 1,500\u002FμL\n  * Platelet count ≥ 75,000\u002FμL Enrollment of patients with lower counts is possible only after consulting the medical monitor.\n* Adequate cardiac functions according to echocardiography (ECHO) within 6 months before study entry\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 12 months after the last dose of study treatment. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\nExamples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n\n* For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing. Women who are considered not to be of childbearing potential are not required to have a pregnancy test.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:\n\nWith female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 5 months after the last dose of polatuzumab vedotin, 3 months after the last dose of rituximab, and for at least 6 months after the last dose of bendamustine to avoid exposing the embryo for the duration of the pregnancy. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment.\n\nExclusion Criteria:\n\n* Prior organ transplantation\n* Current Grade ≥ 2 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* History of other malignancy that could affect compliance with the protocol or interpretation of results Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage\n\n  1 or 2) with no requirement for therapy at any time prior to study are eligible.\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results.\n* Recent major surgery (e.g. within 4 weeks prior to the start of Cycle 1), other than for diagnosis\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1.\n* Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n* Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):\n\nINR \\> 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation aPTT \\> 1.5 x ULN in the absence of a lupus anticoagulant\n\n* Serum AST and ALT \\> 3 x ULN\n* Total bilirubin \\> 2 x ULN Patients with documented Gilbert disease may be enrolled if total bilirubin is \\> 3.0 x ULN.\n* Serum creatinine clearance \\\u003C 40 mL\u002Fmin (using Cockcroft-Gault formula or creatinine levels assessed directly from the collected urine)\n* Patients with suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)\n* Positive test results for chronic hepatitis B infection defined as positive hepatitis B surface antigen (HBsAg) serology\n* Patients with occult or prior hepatitis B infection defined as positive total hepatitis B core antibody and negative HBsAg may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo regular DNA testing and appropriate antiviral therapy as indicated.\n* Positive test results for hepatitis C virus (HCV) antibody serology testing Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* Known history of HIV seropositive status\n* Patients with a history of progressive multifocal leukoencephalopathy\n* Pregnancy or lactation or intending to become pregnant during study\n* CNS lymphoma In patients with clinical signs attributable to CNS lymphoma, CT scan (MRI also acceptable) of the head and examination of cerebrospinal fluid will be required prior to study treatment initiation","80 Years",{"count":219,"type":21},21,[93],"A Czech Lymphoma Study Group, phase II, open-label, study of polatuzumab-vedotin in combination with bendamustine and rituximab for patients with mantle cell lymphoma, who relapse after previous therapy with Bruton tyrosine kinase inhibitor",[66],[224,225,226,227],"refractory\u002Frelapsed mantle cell lymphoma","polatuzumab-vedotin","bendamustine","rituximab","2021-05-28",{"date":230,"type":41},"2021-06-04",{"date":232,"type":21},"2021-09-01",{"date":234,"type":21},"2027-08-31",{"name":236,"class":79},"Czech Lymphoma Study Group","Lymphoma, Mantle-cell"]