[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-refractory-dlbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-refractory-dlbcl":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100642950","phase-2-radiotherapy-in-combination-with-glofitamab-in-relapsedrefractory-diffuse-large-b-cell-lymphoma-100642950",false,"NCT07634289","Radiotherapy in Combination With Glofitamab in Relapsed\u002FRefractory Diffuse Large B Cell Lymphoma","Radiotherapy in Combination With Glofitamab in Relapsed\u002FRefractory Diffuse Large B Cell Lymphoma: The Phase II Radio-GLO Study","Radio-GLO","Inclusion Criteria:\n\n1. Age 18 years.\n2. Histologically proven relapsed\u002Frefractory CD20+ve DLBCL or a recognised subtype, including follicular large B-cell lymphoma and high grade B-cell lymphoma.\n3. Prior systemic treatment: ≥2 lines OR after 1 line AND autologous stem cell transplant\u002FCAR-T ineligible\n4. Eastern Collaborative Oncology Group (ECOG) performance status 0 to 2.\n5. Measurable FDG avid disease on baseline PET\u002FCT scan\n6. At least one site of active, PET positive disease that can be safely irradiated. Patients with disease only in previously irradiated sites that cannot be safely irradiated again due to tissue tolerance will be excluded.\n7. Adequate bone marrow function including:\n\n   * Haemoglobin \\>8.0 g\u002FdL\n   * White cell count (WCC) ≥2000\u002FμL\n   * Neutrophils \\>1.0 x 109\u002FL\n   * Platelets \\>75 x 109\u002FL at the time of study entry, unless attributed to lymphoma. Red cell transfusion is permitted.\n8. Adequate renal function with serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 45mL\u002Fmin (using Cockcroft-Gault formula, Modification of Diet in Renal Disease Study Equation, 24hr urine collection, eGFR or a formal nuclear medicine technique) unless attributed to lymphoma (e.g. ureteric obstruction).\n9. Adequate hepatic function with AST\u002FALT ≤3x ULN and total bilirubin ≤1.5 x ULN (except subjects with Gilbert syndrome, who can have a total bilirubin ≤3 mg\u002FdL or ≤51.3 μmol\u002FL) unless attributed to lymphoma (e.g. liver infiltration or biliary obstruction).\n10. Adequate left ventricular ejection fraction of \\>40% as demonstrated on a Gated Cardiac Blood Pool Scan or echocardiogram.\n11. Life expectancy \\> 3 months.\n12. Patients of childbearing potential willing to adhere to the following contraceptive precautions:\n\n    For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below:\n\n    Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after the final dose of obinutuzumab and 2 months after the final dose of glofitamab. Women must refrain from donating eggs during this same period.\n\n    A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\n    Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n    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 contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\n    For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n    With a female partner of childbearing potential or pregnant female partners, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C1% per year during the treatment period and for at least 6 months after obinutuzumab, and 2 months after the final dose of glofitamab or tocilizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period.\n\n    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 contraception.\n13. Written, informed consent.\n\nExclusion Criteria:\n\n1. Patient has failed only one prior line of therapy and is a candidate for stem cell\n2. Transplantation or CAR-T cell therapy\n3. Excessively bulky or rapidly progressive disease that, in the opinion of the investigator, requires rapid debulking or is unsafe to be irradiated\n4. Richter's transformation from CLL. Transformation from other low-grade histology (e.g. Follicular lymphoma, Marginal zone lymphoma etc) is permitted\n5. Refractory to prior therapy with glofitamab or other anti-CD3\u002FCD20 bispecific antibodies, defined as progression during or within 3 months of cessation.\n6. Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 4 weeks or 5 half-lives (whichever is shorter) prior to first study treatment.\n7. Current central nervous system, meningeal involvement or spinal cord compression by lymphoma. Previous involvement is permitted if there is currently no active CNS disease.\n8. Patients with active, known or suspected autoimmune disease. Patients with well controlled type I diabetes mellitus, coeliac disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, vitiligo or psoriasis not requiring systemic treatment, or other conditions not expected to recur in the absence of an external trigger are permitted to enrol.\n9. Subjects with a condition requiring systemic treatment with either corticosteroids (\\>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration without prior discussion with the medical monitor. Inhaled or topical steroids, and adrenal replacement therapy are permitted in the absence of active autoimmune disease.\n10. Prior solid organ transplantation or allogeneic bone marrow transplantation within 6 months.\n11. Prior malignancy active within the previous 2 years except for those treated with curative intent and with a \\\u003C20% chance of relapse. Low-grade prostate cancer under observation or well controlled on hormone therapy is permitted. Resected or locally treated non-melanoma skin cancer is permitted.\n12. Uncontrolled or severe cardiovascular disease (NYHA class III or IV heart failure; myocardial infarction within the last 6 months of study entry); unstable angina; unstable cardiac arrhythmias; clinically significant pericardial disease.\n13. Any other serious active disease or infection that in the opinion of the investigator takes precedence over the DLBCL, or will impact on the ability to deliver study treatment.\n14. Any positive test result for hepatitis B or hepatitis C virus during screening indicating acute or chronic infection. Latent hepatitis B with undetectable viral load by PCR is allowable provided appropriate anti-viral prophylaxis is given as per institutional guidelines.\n15. Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) unless the viral load is fully suppressed for \\>2 years with a CD4 count of \\>350x106\u002FL and compliant with antiretroviral therapy.\n16. Any history of severe hypersensitivity reactions to other monoclonal antibodies.\n17. A history of allergy or intolerance (unacceptable AEs) to study drug components.\n18. Patients incarcerated or without Medicare\n19. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed\u002Frefractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is:\n\nIf you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments.\n\nParticipants will have three parts they need to complete over a 5 year period.\n\n* Screening period over a 28 day period\n* Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks)\n* Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.",[27],"Relapsed \u002FRefractory DLBCL",[29,30,31,15,32,33,34],"relapsed\u002Frefractory Diffuse Large B Cell lymphoma","Raditherapy","glofitamab","DLBCL","Obinutuzumab - Gazyva, Gazyvaro","Columvi","NOT_YET_RECRUITING","2026-06-03",{"date":38,"type":39},"2026-06-08","ACTUAL",{"date":41,"type":21},"2026-12",{"date":43,"type":21},"2032-12",{"name":45,"class":46},"Olivia Newton-John Cancer Research Institute","OTHER",5,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":47},"100634668","phase-2-double-t---improving-outcomes-in-high-risk-2nd-line-relapsedrefractory-large-b-cell-lymphoma-patients-eligible-for-car-t-cell-therapy-with-a-glofitamab-based-induction-and-consolidation-concept-100634668","NCT07542678","Double-T - Improving Outcomes in High-risk 2nd Line Relapsed\u002FRefractory Large B-Cell Lymphoma Patients Eligible for CAR-T-cell Therapy With a Glofitamab-based Induction and Consolidation Concept","Inclusion Criteria:\n\n1. Patient\\* has given written informed consent.\n2. Patient is 18-80 years of age at time of signing the written informed consent\n3. Patient has histologically confirmed diagnosis of large B-cell lymphoma by local pathologist at time of relapse.\n4. Patient received R-CHOP based first-line therapy containing a CD20-antibody and anthracyclines.\n5. Patient has relapsed\u002Frefractory disease, defined as follows:\n\n   * Relapsed: disease that had recurred following partial or complete response (PR\u002FCR) within 12 months of adequate first-line therapy\n   * Refractory: disease that did not respond to, or that progressed \\\u003C6 months after, completion of first-line therapy\n6. Patient has at least one FDG-PET positive bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi dimensionally measurable (\\>1 cm extranodal lesion, as measured on computed tomography (CT) scan\n7. Patient has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 2\n8. Patient has an absolute lymphocyte count \\> 200\u002FµL\n9. Patient is eligible for CAR-T cell therapy as per investigator´s discretion meeting all of the following criteria of adequate organ function:\n\n   1. Adequate kidney function, defined as: Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 60 mL\u002Fmin.\n   2. Adequate hepatic function, defined as: ALAT and ASAT ≤ 5 ULN. Bilirubin\n\n      ≤ 2.0 mg\u002Fdl (except for Meulengracht disease)\n   3. Adequate bone marrow function, defined as: Absolute neutrophil count (ANC) ≥ 1000\u002FµL, Platelets ≥ 50.000\u002FµL and Hemoglobin \\> 8.0 g\u002FdL.\n   4. Adequate cardiac function, defined as: Cardiac ejection fraction ≥ 45%.\n   5. Adequate pulmonary function as per investigators discretion\n10. Patient successfully performed MNC-leucapheresis procedure for a commercially available CAR-T-cell product\n11. Patient is willing and able to provide baseline biopsy material (archival or fresh tumor sample) for central review\n12. Male patients with female partners of childbearing potential are eligible to participate if they agree to contraceptive methods throughout the duration of the trial and at least 18 months after obinutuzumab administration, 12 months after lost dose oxaliplatin, 6 months after lymphodepletion or 2 months after last dose glofitamab, whatever is last\n13. Female participants of childbearing potential must agree to use a highly effective method of contraception (e.g., hormonal contraception, intrauterine device (IUD), or surgical sterilization) throughout the duration of the trial and at least 18 months after obinutuzumab administration, 15 months after lost dose oxaliplatin, 6 months after lymphodepletion or 2 months after last dose glofitamab, whatever is last. \\* There are no data that indicate special gender distribution. Therefore, patients will be enrolled in the trial gender-independently\n\nExclusion Criteria:\n\n1. Patient has HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and \u002F or presence of RNA confirmed by PCR during screening\n2. Patient has previous or concurrent malignancies with the following exceptions:\n\n   1. Surgically cured carcinoma in-situ\n   2. Other kinds of cancer without evidence of disease for at least 3 years\n3. Patient has known hypersensitivity to any component of the Glofitamab, Obinutuzumab, Yescarta and\u002For Breyanzi formulation formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and\u002For any known contraindication (including hypersensitivity) to one of the other trial drugs\n4. Patient has severe active infection requiring iv treatment within 14 days prior first dose of study drugs\n5. Patient has congenital or acquired immunodeficiency including previous organ or allogeneic stem cell transplantation\n6. Patient received prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n7. Patient received prior treatment with gemcitabine and oxaliplatin in prior lymphoma treatment line\n8. Patient had a major surgery within 4 weeks prior to first dose of study drugs\n9. Patient has primary or secondary central nervous system (CNS) lymphoma at the time of enrollment or history of CNS lymphoma\n10. Patient has current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n11. Patient has significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina\n12. Patient has an active autoimmune disease requiring systemic treatment\n13. Patient receives ongoing corticosteroid use \\>20 mg\u002Fday of prednisone or equivalent. Patients on stable low-dose corticosteroids (≤20 mg\u002Fday of prednisone or equivalent for at least 7-14 days prior to first IMP administration) or on short courses of higher-dose corticosteroids that are completed before first IMP administration are eligible.\n14. Female patients who are pregnant or breast feeding or planning to become pregnant within up to 18 months after start of treatment. Female patients of childbearing potential must have a negative serum pregnancy test result within 3 days prior to initiation of trial treatment.\n15. Patient has a relationship of dependence or employer-employee relationship to the sponsor or the investigator\n16. Patient lacks accountability and inability to appreciate the nature, meaning and consequences of the trial\n17. Patient is non-compliant, for reasons including, but not limited to the following:\n\n    * Increased alcohol consumption, drug dependency or substance abuse that would interfere with cooperation with requirements of the trial\n    * Refusal of blood products during treatment\n    * Any similar circumstances that appear to make protocol treatment or follow-up impossible","80 Years",{"count":56,"type":21},20,[24],"The Double-T trial is a prospective, randomized, single-arm, open-label, multicenter phase II trial investigating a double T-cell therapy strategy, which includes glofitamab with gemcitabine\u002Foxaliplatin (Glofi-Gem\u002FOx) prior to and glofitamab monotherapy consolidation after standard of care Chimeric Antigen Receptor (CAR)-T cell therapy in high-risk 2nd line relapsed\u002Frefractory Large B-Cell Lymphoma (r\u002Fr LBCL) patients.\n\nData on safety, efficacy, and quality of life (QoL) will be collected and analyzed.",[27],"2026-04-17",{"date":62,"type":39},"2026-04-21",{"date":64,"type":21},"2026-04",{"date":66,"type":21},"2030-04",{"name":68,"class":46},"Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest"]