[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Lymphoma Academic Research Organisation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":277},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,72,102,125,147,172,195,226,253],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100587689","phase-2-study-of-epcoritamab-in-rr-primary-diffuse-large-b-cell-lymphoma-of-the-cns-treated-with-lenalidomide-and-rituximab-100587689",false,"NCT06931652","Study of Epcoritamab in R\u002FR Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab","A Phase 2 Study Evaluating Epcoritamab in Subjects With Relapsed and Refractory Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab","E-REVRI","Inclusion Criteria:\n\n1. Subject (or their legally acceptable representative\u002Ftrusted person) who understand and voluntarily signs and dates an informed consent form prior to any study-specific assessments\u002Fprocedures being conducted.\n2. Subject ≥ 18 years old at the time of signing the informed consent form (ICF)\n3. Confirmed histology of primary diffuse large B-cell lymphoma of the CNS (according to the 2022 WHO classification) or confirmed cytology of primary vitreoretinal diffuse large B-cell lymphoma, with CD20 positivity in immunohistochemical staining or flow cytometry at any point in the disease history.\n4. Subjects with relapsed or refractory (R\u002FR) PCNSL or PVRL after at least one line of systemic therapy. Subject with R\u002FR PCNSL must have previously received at least high dose methotrexate. Subject with R\u002FR PVRL must have received either intravenous high dose methotrexate or intraocular methotrexate (PVRL cohort). Subjects can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or PVRL.\n5. ECOG performance status 0 to 2.\n6. Estimated minimum life expectancy of ≥ 2 months.\n7. R\u002FR PCNSL subjects with evaluable disease on brain MRI.\n8. Able to swallow capsules (stomach tube not allowed)\n9. Adequate hematopoietic function:\n\n   * Absolute neutrophil count of ≥ 1.0 G\u002FL without G-CSF support for at least 7 days before screening\n   * Platelet count of ≥ 50 G\u002FL without platelet transfusion within 7 days before screening\n   * Hemoglobin ≥ 8.0 g\u002FdL without RBC transfusion within 7 days before screening\n10. Adequate renal function: calculated by Cockcroft-Gault equation creatinine clearance \\> 40 ml\u002Fmin. Subjects with calculated creatinine clearance \\> 40 and \\\u003C 60ml\u002Fmin lenalidomide dose will be adjusted.\n11. Adequate liver function: Serum total bilirubin level ≤ 2.0 mg\u002Fdl \\[34 µmol\u002FL\\] (unless bilirubin rise is due to Gilbert's syndrome) and serum transaminases (AST or ALT) ≤ 3 upper normal limits.\n12. Able to understand teratogenic risks of the treatment (Lenalidomide).\n13. Women of childbearing potential (WOCBP) should agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study treatment, 2) while participating in the study, 3) dose interruptions, and 4) for at least 12 months after the final dose of rituximab, or for at least 12 months after the final dose of epcoritamab, or for at least 28 days after the final dose of lenalidomide . WOCBP should also agree to abstain from breastfeeding during study participation and for at least 4 months after discontinuation of all study treatments.\n14. WOCBP should have a negative serum (beta-hCG) pregnancy test at screening and a negative serum or urine pregnancy test before treatment administration on Day 1 of every cycle.\n15. Women should agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire study, until 12 months after the last administration of study treatment.\n16. Man who is sexually active with a female of reproductive potential and has not had a vasectomy should agree to use a highly effective \u002F an acceptable method of birth control (ie, condom) and must agree not to donate sperm, until 28 days after the final dose of lenalidomide and\u002For until 12 months after the final dose of epcoritamab and rituximab.\n17. Subject covered by any social security system (France).\n18. Subject (or their legally acceptable representative\u002Ftrusted person) who understands and speaks one of the country official languages unless local regulation authorizes independent translators.\n\nExclusion criteria:\n\nSubject who meets any of the following criteria should be excluded from enrollment in the study:\n\n1. T-cell lymphoma.\n2. Cerebral localization of a systemic lymphoma.\n3. Prior history of organ transplantation or other cause of severe immunodeficiency.\n4. Known Human Immunodeficiency Virus (HIV) or Positive HTLV1 serology.\n5. Active Hepatitis B Virus (HBV) infection (DNA PCR-positive) or active hepatitis C Virus (HCV) infection (RNA PCR-positive). Subjects with evidence of prior HBV infection but who are PCR-negative are permitted in the study but should receive prophylactic antiviral therapy. Subjects who received treatment for HCV infection that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.\n6. Persistent SARS-CoV-2 infection. Subjects who have had or currently have a SARS-CoV-2 infection must demonstrate symptom resolution and provide a negative nasopharyngeal PCR test at time of inclusion. Both of these requirements must be met for the subject to be considered clear of the virus.\n7. Impossibility to follow the calendar of exams because of geographic, social, or psychological reasons.\n8. Active malignancy other than the one treated in this Study. Prior history of malignancies (other than inclusion diagnosis) 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. Non-invasive basal cell or epidermoid carcinoma\n   2. In situ Carcinoma of the cervix\n   3. In situ Carcinoma of the breast\n   4. Non-invasive, superficial bladder cancer\n   5. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis \\[TNM\\] clinical staging system\n   6. Any curable cancer with a complete response of \\>2 years duration\n9. Known or suspected hypersensitivity to the active substance or to any of the excipients.\n10. Any previous treatment with CAR-T therapy within 30 days prior to enrollment.\n11. Receiving immunosuppressive therapy, including more than the equivalent of 20 mg of prednisolone daily, unless for control of lymphoma or intermittent prophylaxis\u002Ftreatment of allergic reactions.\n12. Any previous treatment with a bispecific antibody targeting CD3 and CD20 and\u002For with lenalidomide, regardless of the time and duration.\n13. Seizure disorder requiring anti-epileptic therapy unless related to lymphoma.\n14. Vaccination with live, attenuated vaccines within 28 days prior of enrollment (except severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine). Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Experimental and\u002For non-authorized SARS-CoV-2 vaccinations are not allowed.\n15. Use of any standard or experimental anti-cancer drug therapy within 28 days of the start (Day 1) of study treatment.\n16. Major surgery within 4 weeks prior to enrollment\n17. Clinically significant cardiovascular disease, including:\n\n    1. Myocardial infarction within 1 year prior to enrollment, or unstable or uncontrol disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV) cardiac arrhythmia (CTCAE Version 5.0 Grade 2 or higher), or clinically significant ECG abnormalities.\n    2. Stroke within 6 months prior to enrollment.\n18. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\>470 msec.\n19. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment at time of enrollment.\n20. Contraindication to all uric acid lowering agents.\n21. Clinically significant liver disease, including active hepatitis, current alcohol abuse, or cirrhosis.\n22. Active tuberculosis or history of treatment for active tuberculosis within the past 12 months.\n23. Receiving immunostimulatory agent.\n24. Prior allogeneic hematopoietic stem cell transplantation.\n25. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision).\n26. Subject deprived of his\u002Fher liberty by a judicial or administrative decision.\n27. Subject hospitalized without consent.\n28. Adult subject under legal protection.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this phase 2 study is to evaluate the efficacy and safety of epcoritamab in subjects with relapsed or refractory primary diffuse large B-cell lymphoma of the Central Nervous System treated with rituximab and lenalidomide.",[27],"Primary CNS Lymphoma (PCNSL)",[29,30,31,32,27],"primary CNS lymphoma","treatment for primary CNS lymphoma","epcoritamab treatment","rituximab and lenalidomide treatment","RECRUITING","2026-06-12",{"date":36,"type":37},"2026-06-15","ACTUAL",{"date":39,"type":37},"2025-09-22",{"date":41,"type":21},"2030-01",{"name":43,"class":44},"The Lymphoma Academic Research Organisation","OTHER",13,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100516561","phase-3-mosunetuzumab-lenalidomide-versus-investigator-choices-in-patients-with-relapsed-or-refractory-marginal-zone-lymphoma-100516561","NCT06006117","Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma","Phase III, Multicenter, Open Label, Randomized, Controlled Study Investigating Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma","Inclusion criteria:\n\n1. Have a biopsy proven diagnosis of MZL, extranodal (EMZL) or nodal (NMZL) Or have a diagnosis of splenic MZL (SMZL) based on mandatory 13 flow cytometry markers: surface immunoglobulins (SmIg), CD5, CD23, FMC7, CD22 or CD79b, CD200, CD180, CD20, CD43, CD11c, CD10,CD103 and CD123 and validated by a centralized review.\n\n   In case of large dissemination, disseminated MZL (as evaluated by investigator; please contact the Sponsor to discuss any doubt) will be included as DMZL and included in NMZL subtype. Participants with high tumor burden criteria are eligible.\n\n   Participants with borderline or related entities, such as splenic diffuse red pulp lymphoma (SDRPL), typical hairy cell leukemia (HCL), and HCL variant (HCLv), are not eligible.\n2. Have been treated with at least one prior systemic treatment and not more than three prior lines. Previous line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles; participants treated with monoclonal antibody monotherapy should have received at least 4 weekly injections) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as BTK inhibitors (at least 1 month). Participants previously treated by lenalidomide are eligible if the last administration of lenalidomide is superior to 12 months before C1D1. When randomized in comparator arm, those participants should require R-chemo. Prior local therapy (including surgery, radiotherapy antibiotics for H. pylori-positive gastric lymphoma, and antiviral for hepatitis C virus) is not considered as one line of treatment\n3. Signed Informed Consent Form\n4. Age ≥ 18 years at the time of signing the informed consent form\n5. Ability to comply with the study protocol and procedures and required hospitalizations, in the investigator's judgement\n6. Eastern Cooperative Oncology Group (ECOG) performance score (PS) of ≤ 2\n7. Have a symptomatic disease requiring a systemic treatment\n8. Not eligible for a local treatment including radiotherapy or surgery\n9. Stage I disease of EMZL, SMZL or NMZL may be eligible only if not candidate to local therapy (surgery or radiotherapy).\n10. Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with ≥ 15 mm in longest transverse diameter or the short diameter must measure ≥ 10 mm regardless of the longest transverse diameter.\n\n    Spleen is considered as a measurable disease if vertical axis is higher than 130 mm.\n11. Adequate hematopoietic function at screening as follows unless cytopenia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune thrombocytopenia:\n\n    11.1. Platelet count ≥ 75 G\u002FL; in cases of thrombocytopenia clearly due to marrow involvement of MZL or hypersplenism or auto-immune thrombocytopenia, platelet count should be ≥ 30 G\u002FL. Washout platelet transfusion is 7 days between transfusion and D1 of starting treatment 11.2. Absolute Neutrophil Count (ANC) ≥ 1 G\u002FL unless neutropenia is clearly due to marrow involvement of MZL or hypersplenism. G-CSF is not allowed within 7 days before starting treatment 11.3. Total hemoglobin ≥ 8 g\u002FdL unless anemia is clearly due to marrow involvement of MZL or hypersplenism or autoimmune hemolytic anemia. Washout erythrocyte transfusion is 7 days between transfusion and D1 of starting treatment\n12. Serum total bilirubin ≤ 1.5 x the upper limit of normal (ULN) (or ≤3 x ULN for participants with Gilbert syndrome),\n13. AST or ALT ≤ 2.5 x ULN, unless directly attributable to the participant's MZL\n14. Measured or estimated creatinine clearance ≥ 40 mL\u002Fmin by institutional standard method\n15. Participants who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation. Participants who are hepatitis B surface antigen (HBsAg) negative, hepatitis B surface antibody (anti-HBsAb) positive and hepatitis B core antibody (HBcAb) negative are eligible,\n16. Contraception:\n\n    16.1. For women of childbearing potential (WOCBP) (refer to section 14.6.1):\n    * must have a negative result for pregnancy test (highly sensitive serum) within 7 days before randomization and within 7 days before initiation of study treatment.\n    * must agree to abstain from becoming pregnant or breastfeeding, and agree to use highly effective contraceptive methods during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP (if applicable), 6 months after the final dose of bendamustine (if applicable) and 12 months after the final dose of rituximab (if applicable).\n\n    16.2. For men: with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 28 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine and 12 months after the final dose of rituximab (if applicable). ). Men must also agree to refrain from donating sperm from the first day of treatment until at least 7 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), and 12 months after the final dose of rituximab (if applicable)\n17. Participants covered by any social security system (France).\n18. Participants who understand and speak one of the country official languages.\n19. LVEF within normal range (i.e. \\> 50% as evaluated by Transthoracic Echocardiography or \\> 45% as evaluated by isotopic method (MUGA scan)).\n\nExclusion criteria:\n\n1. MZL with histologic transformation to high-grade lymphoma\n2. Participants who have received any of the following treatments prior to study entry:\n\n   * Treatment with mosunetuzumab or other CD20\u002FCD3-directed bispecific antibodies\n   * Allogeneic stem cell transplant\n3. Participants who have received any of the following treatments, whether investigational or approved, within the respective time periods prior to initiation of study treatment:\n\n   * Radiotherapy within 2 weeks prior to the first dose of study treatment\n   * Autologous stem cell transplant within 100 days prior to first study treatment\n   * Use of monoclonal antibodies within 4 weeks prior to first study treatment\n   * Systemic immunosuppressive medications (including, but not limited to, Cyclophosphamide, Azathioprine, Methotrexate, Thalidomide, and anti-tumor necrosis factor agents) and corticosteroids on the long run with the following exceptions: inhaled steroids for asthma, topical steroids, or replacement or stress corticosteroids during the study at any time. Participants who require lymphoma symptom control during screening may receive corticosteroid \\\u003C or = 1mg\u002Fkg\u002Fday prednisone or equivalent for a maximum of 10 days prior to first dose of study treatment.\n   * Any other anti-cancer investigational therapy within 4 weeks prior to initiation of study treatment.\n4. Pregnant or breastfeeding or intending to become pregnant during the study or within 28 days after the final dose of lenalidomide, 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP, 6 months after the final dose of bendamustine and 12 months after the final dose of rituximab (if applicable).\n5. Received a live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 6 months after the final dose of study treatment, except for acute pandemic situation such as COVID19\n6. Active or history of CNS lymphoma or leptomeningeal infiltration\n7. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins) - grade 3 and 4\n8. Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including Mannitol\n9. Participants unable to receive adequate prophylaxis and\u002For therapy for thromboembolic events (aspirin or low molecular weight heparin or direct oral anticoagulants)\n10. History of prior malignancy, except for conditions as listed below if participants have recovered from the acute side effects incurred as a result of previous therapy and only with a single occurrence of the following conditions:\n\n    * Malignancies treated with curative intent and with no known active disease present for ≥ 2 years before enrollment\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated cervical carcinoma in situ without evidence of disease\n    * Surgically\u002Fadequately treated low grade, early stage I, localized prostate in situ carcinoma\n11. Participants with infections requiring IV treatment with antibiotics or hospitalization (Grade 3 or 4) within the last 4 weeks prior to inclusion or known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds),\n12. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:\n\n    * Significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association)\\], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)\n    * Significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)\n    * Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis\n    * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible.\n13. History of confirmed progressive multifocal leukoencephalopathy (PML)\n14. Known Positive serologic HIV test at screening\n15. Acute or chronic hepatitis C virus (HCV) infection Participants who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation.\n16. Known or suspected history of hemophagocytic lymphohistiocytosis\n17. Known or suspected chronic active Epstein-Barr virus (EBV) infection within the last 4 weeks prior to inclusion\n18. History of erythema multiforme, Grade ≥3 rash, or blistering following prior treatment with immunomodulatory derivatives\n19. History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis\n20. Active autoimmune disease requiring treatment\n21. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; except:\n\n    * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n    * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible\n    * Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Medical Monitor.\n22. Recent major surgery with risk of bleeding within 4 weeks prior to first study treatment administration (C1D1)\n23. History of solid organ transplantation\n24. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study\n25. Person deprived of his\u002Fher liberty by a judicial or administrative decision\n26. Person hospitalized without consent\n27. Adult person under legal protection\n28. Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness\n29. Participant unable to receive at least one of the three regimens of the comparator arm. As in usual practice, physician has to verify the absence of contraindication to the use of the drugs, hypersensitivity, and to take into account the lymphoma history and previous treatment scheme used\n30. Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment (e.g. very high SUV (SUV \\> 20 or double compared to SUV of other lesions) in at least one lesion that was not biopsied, and discordant with SUV of biopsied lesion, LDH \\> 2.5 ULN in a context of rapidly progressive disease, etc). Please contact the Coordinating Investigators \u002F Sponsor to discuss such cases or if there is any doubt before considering enrollment.\n31. Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment within 48 hours (participants with controlled disease after adequate pleural\u002Fserous drainage and\u002For effective pleurX™ or similar system are eligible only if control system is in place before randomization).\n32. Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure (participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if control system is in place before randomization).",{"count":54,"type":21},260,[56],"PHASE3","This is an open label, multi-center, international, randomized phase III trial to compare the efficacy of Mosunetuzumab-Lenalidomide with investigator choices exclusively in R\u002FR MZL patients. Patients with a proven diagnosis of EMZL, SMZL or NMZL subtypes and previously treated with at least one prior systemic treatment and not more than three prior lines are eligible. Previous treatment line must include at least one systemic line with a drug targeting CD20 (monoclonal antibody at least 2 cycles) with or without chemotherapy (R-CHOP, R-Bendamustine, R-CVP, R-Chlorambucil at least 2 cycles) or targeted treatment such as Ibrutinib.\n\nThe patients will be Randomized as follows:\n\nArm A - Experimental arm:\n\n• Mosunetuzumab-Lenalidomide\n\nArm B - Comparator arms ( Investigator Choices):\n\n* Rituximab-Lenalidomide\n* Rituximab-Bendamustine\n* Rituximab-CHOP",[59],"Marginal Zone Lymphoma",[61,62,59,63,64],"Bispecific antibodies, Subcutaneous","Step-up dosing","Investigator choices","R\u002FR MZL",{"date":36,"type":37},{"date":67,"type":37},"2023-09-05",{"date":69,"type":21},"2032-09",{"name":43,"class":44},48,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100632517","proof-of-concept-for-real-time-multicentric-monitoring-of-mrd-by-pet-and-ctdna-in-aggressive-b-cell-lymphomas-100632517","NCT07514715","Proof of Concept for Real-time Multicentric Monitoring of MRD by PET and ctDNA in Aggressive B-Cell Lymphomas","Proof of Concept for Real-time Multicentric Monitoring of Minimal Residual Disease (MRD) by PET and Circulating Tumor DNA (ctDNA) in Aggressive B-Cell Lymphomas","RT4","Inclusion criteria\n\nParticipants must meet all of the following criteria to be included in the study:\n\n1. Participant who understands and voluntarily signs an informed consent form prior to any study-specific assessment or procedure.\n2. Age 18 or older at the time of signing the Informed Consent Form (ICF)\n3. Histologically confirmed diagnosis, according to the WHO 2022 classification, of any of the following lymphomas:\n\n   Aggressive B-cell lymphoma, including:\n   * Diffuse large B-cell lymphoma, unspecified (DLBCL not specified)\n   * High-grade B-cell lymphoma (LBHG), including:\n\n     1. With rearrangements of the MYC and BCL2 and\u002For BCL6 genes (double\u002Ftriple hit)\n     2. Unspecified (i.e., no double\u002Ftriple rearrangement)\n   * Primary B-cell lymphoma of the mediastinum (PMBL)\n   * Transformed indolent B-cell lymphoma, including:\n\n     1. Transformed follicular lymphoma (LFt)\n     2. Transformed marginal zone lymphoma (t-MZL)\n     3. Transformed, unspecified nodal or splenic B-cell lymphomas (NOS)\n4. Presence of a measurable disease on pre-therapeutic PET imaging, defined as at least one two-dimensional measurable nodal lesion, defined as \\> 1.5 cm in its largest dimension (and FDG-greedy lesion), or at least one two-dimensional measurable extranodal lesion, defined as \\> 1.0 cm in its largest dimension (and FDG-hungry lesion).\n5. Requiring standard first-line systemic treatment with curative intent\n6. Person covered by a social security scheme\n7. Person able to understand and speak French. Exclusion criteria\n\nParticipants who meet any of the criteria below will not be eligible for inclusion \u002F should be excluded from the study:\n\n1. Systemic anticancer treatment of current lymphoma prior to inclusion in the study. All participants must be previously untreated for current lymphoma.\n\n   Note: Short-term corticosteroid therapy (e.g., for symptom control or as part of diagnostic workup) is allowed prior to inclusion and is not an exclusion criterion.\n2. Lymphomas associated with an immuno-privileged site (e.g., primary central nervous system lymphoma, primary testicular lymphoma, primary vitreoretinal lymphoma).\n3. Absence of mandatory blood sampling for the analysis of circulating tumor DNA (ctDNA) during screening (pre-therapeutic sampling).\n4. Absence of 18F-FDG PET examination performed within 2 months ≤ the date of signing the consent (mandatory pre-therapeutic PET imaging).\n5. Pregnant, intending to be pregnant, or breastfeeding woman of childbearing potential\n6. Any significant medical condition, laboratory abnormality, or psychiatric illness that may interfere with participation in this clinical study (in the opinion of the investigator)\n7. Person deprived of liberty by judicial or administrative decision\n8. Person hospitalized without their consent\n9. Adult under legal protection",{"count":81,"type":21},129,"OBSERVATIONAL","RT4 (REAL TIME TAILORED THERAPY) study was designed as a national, multicenter proof of concept aiming to demonstrate the technical and operational capacity of the French Connect network and the Positron Emission Tomography (PET) review network to ensure, within a coordinated framework, real time MINIMAL RESIDUAL DISEASE (MRD) monitoring through ctDNA analysis and centralized review of PET imaging.",[85],"Aggressive B-cell Lymphomas",[87,88,89,90,91],"Circulating Tumor DNA","Measurable Residual Disease","Large B-Cell Lymphoma","PhasED-Seq","PET-Scan in Lymphoma","NOT_YET_RECRUITING","2026-06-09",{"date":95,"type":37},"2026-06-11",{"date":97,"type":21},"2026-06-30",{"date":99,"type":21},"2028-10-01",{"name":43,"class":44},30,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100537922","phase-3-study-of-mosunetuzumab-plus-lenalidomide-compared-to-anti-cd20-anti-body--chemotherapy-in-follicular-lymphoma-flipi2-5-100537922","NCT06284122","Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5","A Phase III Randomized, Open-label, International, Multicenter Study Evaluating the Efficacy and Safety of Mosunetuzumab Plus Lenalidomide in Comparison to Anti-CD20 Monoclonal Antibody Plus Chemotherapy in Subjects With Previously Untreated FLIPI 2-5 Follicular Lymphoma","MorningLyte","Inclusion Criteria:\n\n1. 1\\. Patient with histologically proven previously untreated CD20+ follicular lymphoma grade 1, 2, or 3a (including patient watched during up to 10 years after initial diagnosis) as assessed by the investigators according to the WHO 2016 classification12, or classical follicular lymphoma according to the WHO 2022 classification13. Diagnostic tissue must be available for central pathology review, exploratory endpoints and secondary data use.\n2. FLIPI 2-5.\n3. All Ann Arbor stages (including stage I if FLIPI ≥ 2).\n4. Must need treatment as evidenced by at least one of the following criteria:\n\n   4.1. Bulky disease defined as one of the following: 4.1.1. a nodal or extranodal mass\u002Flesion \\> 70 mm in its largest diameter or, 4.1.2. involvement of at least 3 different nodal or extranodal sites (each with a diameter greater than \\> 30 mm) 4.2. Presence of at least one of the following B symptoms within the prior 6 months: 4.2.1. fever (\\> 38°C) of unclear etiology 4.2.2. night sweats 4.2.3. weight loss greater than 10% 4.3. Symptomatic splenomegaly 4.4. Symptomatic lesion: 4.4.1. painful lesion and\u002For 4.4.2. any compressive syndrome (for example, but not restricted to- ureteral, orbital, gastrointestinal) 4.5. Any one of the following cytopenias due to lymphoma: 4.5.1. hemoglobin \\\u003C 10g\u002FdL (6.25 mmol\u002FL) 4.5.2. platelets \\\u003C100 x 109\u002FL, or 4.5.3. absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL 4.6. Pleural or peritoneal serous effusion (irrespective of cell content) 4.7. Abnormal biological prognostic parameters: (item not applicable for Germany) 4.7.1. β2microglobulin \\> ULN or 4.7.2. LDH \\> ULN\n5. At least one bi-dimensionally measurable nodal lesion, defined as \\> 15 mm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \\> 10 mm in its longest dimension (and FDG-avid lesion).\n6. Participant who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures.\n7. Must be ≥ 18 years old at the time of signing the informed consent form (ICF).\n8. ECOG performance status 0 to 2.\n9. Estimated minimum life expectancy of 3 months.\n10. Adequate hematological function within 28 days prior to randomization, including:\n\n    10.1. Absolute neutrophil count (ANC) ≥ 1 x 109\u002FL 10.2. Platelet count ≥ 75 x 109\u002FL, or ≥ 30 x 109\u002FL if bone marrow infiltration or splenomegaly 10.3. Hemoglobin ≥ 8.0 g\u002FdL (5 mmol\u002FL) unless related to bone marrow infiltration or splenomegaly. Transfusion is allowed before starting treatment (no required window)\n11. Normal laboratory values:\n\n    11.1. Measured or estimated creatinine clearance ≥ 40mL\u002Fmin calculated by institutional standard method (MDRD or Cockcroft-Gault 11.2. AST or ALT ≤ 2.5 x the upper limit of normal (ULN), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 5 x ULN 11.3. Serum total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for patients with Gilbert syndrome), except in patients with documented liver or pancreatic involvement by lymphoma ≤ 3 x ULN\n12. LVEF within normal range (i.e. \\> 50% as evaluated by Transthoracic Echocardiography or \\> 45% as evaluated by isotopic method (MUGA scan).\n13. Participants should be able to receive adequate prophylaxis and\u002For therapy for thromboembolic events (aspirin, low molecular weight heparin or direct oral anticoagulants).\n\n    Patients with a curative anticoagulation therapy can be enrolled. A patient with deep vein thrombosis due to compressive syndrome is eligible if a curative anticoagulation therapy has been started at least 1 week before initiating study treatment: low molecular weight heparin possible at treatment onset, then direct oral anticoagulants according to local practices.\n14. Must be able to adhere to the study visit schedule and other protocol requirements.\n15. No more applicable following SM#14\n16. Negative HIV test before randomization, with the following exception:\n\n    Patients with a positive HIV test before randomization are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.\n17. For women of childbearing potential (WOCBP) :\n\n    * must have a negative result for pregnancy test (highly sensitive serum) within 7 days before randomization and within 7 days before initiation of study treatment.\n    * must agree to abstain from becoming pregnant or breastfeeding, and agree to use highly effective contraceptive methods during study participation, and for at least 28 days after the final dose of lenalidomide (if applicable), 3 months after the final dose of mosunetuzumab and tocilizumab (if applicable), 12 months after the final dose of CHOP (if applicable), 6 months after the final dose of bendamustine (if applicable), 12 months after the final dose of rituximab (if applicable), and 18 months after the final dose of obinutuzumab (if applicable).\n18. For men with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period (including periods of treatment interruption), and for at least 07 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), 12 months after the final dose of rituximab (if applicable), and 3 months after the final dose of obinutuzumab (if applicable). Men must also agree to refrain from donating sperm from the first day of treatment until at least 7 days after the final dose of lenalidomide (if applicable), 2 months after the final dose of tocilizumab (if applicable), 6 months after the final dose of CHOP (if applicable), 3 months after the final dose of bendamustine (if applicable), 12 months after the final dose of rituximab (if applicable), and 3 months after the last dose of obinutuzumab (if applicable).\n19. Participant covered by any social security system (France).\n20. Participant who understands and speaks one of the country official languages, unless local regulation authorizes independent translators.\n\nExclusion criteria:\n\n1. Grade 3b follicular lymphoma according to the WHO 2016 classification12, or follicular large B-cell lymphoma according to the WHO 2022 classification13\n2. Suspicion or clinical evidence of transformed lymphoma at enrollment by investigator assessment.\n\n   Examples: patients with high or intermediate high SUV (\\>20) in any nodal or extranodal site particularly in the bones (vertebrae etc) unless biopsy proven to be genuine FL grade 1,2, 3A ; and\u002For discordant (e.g. SUV doubled) with SUV of other sites including the biopsy site.; and\u002For LDH \\> 2.5 x ULN in a context of rapidly progressive disease, etc. Please contact the Coordinating Investigator \u002F Sponsor to discuss such cases or if there is any doubt before considering enrolment.\n3. Prior localized radiotherapy for the FL.\n4. Prior history of another lymphoma.\n5. Uncontrolled symptomatic pleural or serous effusion requiring urgent treatment (within one week of finding). Participants may only be enrolled after Coordinating investigator \u002F sponsor approval once confirmed participant is durably asymptomatic after adequate pleural\u002Fserous drainage or only if an efficient drainage device (e.g.pleurX™) is in place before randomization.\n6. Uncontrolled symptomatic ureterohydronephrosis resulting in renal failure. Participants with adequate management i.e. ureteral catheter or double J stent allowing renal failure control are eligible only if urinary catheter is in place before randomization.\n7. Presence or history of symptomatic or threatening lymphomatous epidural\u002Fnerve root lesion, even such participants whose disease is controlled by short course of steroids are NOT eligible.\n8. Use of any standard or experimental anti-cancer drug therapy within 45 days of the start (Day 1) of study treatment.\n9. Any contraindication to any drug contained in the study treatment control arms or in the Auxiliary Medicinal Products (AxMPs)\n10. Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) and corticosteroids on the long run with the following exceptions: inhaled steroids for asthma, topical steroids, or replacement or stress corticosteroids during the study at any time. Participants who require lymphoma symptom control during screening may receive corticosteroid \\\u003C or = 1mg\u002Fkg\u002Fday prednisone or equivalent for a maximum of 10 days prior to first dose of study treatment\n11. Received a live, attenuated vaccine within 4 weeks before the first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 6 months after the final dose of study treatment.\n12. Major surgery (excluding surgical documentation of FL) within 28 days prior to signing informed consent.\n13. Seropositive for or active viral infection with hepatitis B virus (HBV):\n\n    * HBsAg positive\n    * HBsAg negative, anti-HBs positive and\u002For anti-HBc positive and detectable viral DNA (Patients who are HBsAg negative, anti-HBs positive and\u002For anti-HBc positive but viral DNA negative are eligible. They should be treated and perform testing at regular interval described in section Anti infectious prophylaxis; Patients who are seropositive due to a history of hepatitis B vaccine (anti-HBs positive) are eligible).\n14. Known seropositive for, or active infection hepatitis C virus (HCV) (Patients who are positive for HCV antibody with a negative viral RNA are eligible).\n15. Known or suspected hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, anti-CD20 mAb, tocilizumab, lenalidomide formulation, including mannitol; or to any of the excipients.\n16. History of solid organ transplantation or allogeneic stem cell transplant (SCT).\n17. Active autoimmune disease requiring treatment.\n18. History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, uveitis, or glomerulonephritis.\n\n    * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n    * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Participants with a remote history of, or well-controlled autoimmune disease, with a treatment-free interval from immunosuppressive therapy for 12 months may be eligible after review and discussion with the Coordinating investigator.\n19. Participants with any active infection such as known active bacterial, viral (including SARS-CoV-2), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds), known or suspected chronic active Epstein-Barr virus (EBV) infection are excluded.\n20. Evidence of any significant, concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to:\n\n    * significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association), myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina)\n    * significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)\n    * clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis\n    * current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 1 year and have no residual neurologic deficits as judged by the investigator are allowed. Participants with a history of epilepsy who have had no seizures in the past 2 years with or without anti-epileptic medications can be eligible.\n21. History of confirmed progressive multifocal leukoencephalopathy (PML).\n22. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n23. History of erythema multiforme, Grade ≥3 rash, or blistering rash following prior treatment with immunomodulatory derivatives.\n24. History of interstitial lung disease (ILD), drug-induced pneumonitis, and autoimmune pneumonitis.\n25. Active malignancy other than the one treated in this research. Prior history of malignancies unless the patient has been free of the disease and therapy for ≥ 3 years. However, patients with a single occurrence of the following conditions that have been treated with curative intent are eligible:\n\n    * Localized non-melanoma skin cancer.\n    * Carcinoma in situ of the cervix.\n    * Carcinoma in situ of the breast.\n    * Incidental histologic finding of prostate cancer (T1a or T1b as per Tumor Node Metastasis \\[TNM\\] staging system) or prostate cancer.\n26. Presence or history of CNS or meningeal involvement by lymphoma.\n27. Pregnant, planning to become pregnant or lactating WOCBP.\n28. Any significant medical conditions, including the presence of laboratory abnormality or psychiatric illness which places the patient at unacceptable risk if he\u002Fshe were to participate in the study, and likely to interfere with participation in this clinical study (according to the investigator's decision) or which confounds the ability to interpret data from the study.\n29. Person deprived of his\u002Fher liberty by a judicial or administrative decision.\n30. Person hospitalized without consent.\n31. Adult person under legal protection.\n32. Patients with absolute lymphocyte count \\> 20 G\u002FL before randomization. Participants circulating lymphoma cell≥ 5 G\u002FL must be discussed with the Sponsor before randomization.\n\nNB: for 29-31., if there is an individual benefit for such patients, an Ethics Committee will have to be informed case by case.",{"count":111,"type":21},790,[56],"This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma.",[115],"Follicular Lymphoma","2026-06-03",{"date":118,"type":37},"2026-06-05",{"date":120,"type":37},"2024-06-07",{"date":122,"type":21},"2034-04",{"name":43,"class":44},116,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":131,"targetDuration":133,"studyType":82,"phases":4,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":101},"100592495","glofitamab-in-real-life-100592495","NCT06994169","Glofitamab in Real Life","Inclusion Criteria:\n\n* patient enrolled in the French Glofitamab EAP for R\u002FR DLBCL before 2024 November 1st, 2024\n* patient who received at least Obinutuzumab pretreatment and one infusion of Glofitamab\n* adult patient\n* patient who is informed of the study and who did not oppose to their data collection\n\nExclusion Criteria:\n\n* none",{"count":132,"type":21},250,"6 Months","To date, more than 300 patients have been treated with Glofitamab in the Expanded Access Programme (EAP) in France. In this study, it is proposed to perform a retrospective analysis of some of these patients. The aim is to describe the efficacy and safety of Glofitamab in the largest reported real-world cohort, with an expected median follow-up of more than 9 months. Particular focus will be given to the relapsed or refractory chimeric antigen receptors-T (CAR-T) population to confirm the response rates (CRR: 35-39%) of Glofitamab in this population and to assess the optimal timing of therapy initiation \\[8, 15\\].",[136],"Large B-cell Lymphoma",[138,139],"CAR-T","Glofitamab","2026-06-02",{"date":116,"type":37},{"date":143,"type":37},"2025-12-01",{"date":145,"type":21},"2026-12-30",{"name":43,"class":44},{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":22,"phases":156,"briefSummary":157,"conditions":158,"keywords":163,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":45},"100536917","phase-2-golcadomide-post-car-t-cell-in-rr-aggressive-large-b-cell-lymphoma-patients-with-high-risk-of-relapse-100536917","NCT06271057","Golcadomide Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Golcadomide (BMS-986369) Post-CAR T-cell in R\u002FR Aggressive Large B-cell Lymphoma Patients With High Risk of Relapse","Inclusion Criteria:\n\n1. Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted\n2. Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)\n3. Eligible for any commercialized market authorized anti-CD19 CAR T-cells\n4. Performance Status 0, 1, or 2\n5. With aggressive large B-cell lymphoma, including:\n\n   * diffuse large B-cell lymphoma\n   * Primary mediastinal B-cell lymphoma\n   * Any transformed follicular or marginal zone lymphoma\n   * high-grade B-cell lymphoma (HGBL) Note: patients with Central Nervous System (CNS) involvement could be included but not patients with primary CNS lymphoma\n6. Available biopsy for centralized review\n7. With a CAR T-cells indication as soon as 2nd line treatment no later than in 4th line, previously validated by the multidisciplinary tumor board Note: Any treatment performed prior to leukapheresis is considered a line of treatment\n8. Total MetabolicTumor Volume (TMTV) \\> 80 ml, measured by centralized review, on standard18FDG-PET (positron emission tomography) done just before starting CAR T-cells procedure (i.e., D-13 +\u002F- 4 days before lymphodepletion)\n9. Creatinine clearance (as estimated by Modification of Diet in Renal Disease (MDRD) if \\> 60-year-old or Cockcroft-Gault if \\\u003C60yo) \\>45 mL\u002Fmin,\n10. Adequate hepatic function:\n\n    * aspartate aminotransferase\u002Falanine aminotransferase (ALT\u002FAST) ≤ 3.0 x ULN. (Note: In the case of documented liver involvement by lymphoma, ALT\u002FAST must be ≤ 5.0 x ULN)\n    * Serum total bilirubin ≤ 2.0 mg\u002FdL (34 μmol\u002FL) (Note: In the case of Gilbert's syndrome, or documented liver or pancreatic involvement by lymphoma, serum total bilirubin must be ≤ 3.0 mg\u002FdL (51 μmol\u002FL))\n11. Patient covered by any social security system (France)\n12. Patient who understands and speaks one of the country official languages, unless local regulation authorizes independent translators\n13. Contraception:\n\n    * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method, as soon as consent is signed, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, Women must refrain from donating eggs during this same period.\n\nExclusion Criteria:\n\n1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years\n2. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor\n3. History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines\n4. Significant pulmonary function impairment and oxygen saturation (SaO2) \\\u003C 92% on room air\n5. Significant cardiovascular disease such as New York Heart Association Class III or IV or Objective Class C or D cardiac disease (see appendix 07)\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n8. Current treatment with strong CYP3A4\u002F5 modulators (see appendix 13)\n9. Pregnant, planning to become pregnant or lactating Women of Child Bearing Potential\n10. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision)\n11. Person deprived of his\u002Fher liberty by a judicial or administrative decision\n12. Person hospitalized without consent\n13. Adult person under legal protection",{"count":155,"type":21},65,[24],"This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.\n\nApproximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.\n\nThe duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.\n\nThe primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.",[159,160,161,162],"Diffuse Large B-cell Lymphoma Refractory","Refractory Primary Mediastinal Large B-Cell Lymphoma","Refractory Transformed B-cell Non-Hodgkin Lymphoma","Refractory High Grade B-Cell Lymphoma",[164],"eligible for CAR T-cells therapy",{"date":166,"type":37},"2026-06-04",{"date":168,"type":37},"2024-06-14",{"date":170,"type":21},"2028-12-31",{"name":43,"class":44},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":182,"studyType":82,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},"100387712","french-register-of-patients-with-hemopathy-eligible-for-car-t-cell-treatment-descar-t-100387712","NCT04328298","French Register Of Patients With Hemopathy Eligible For CAR-T Cell Treatment (DESCAR-T)","Inclusion Criteria:\n\nRetrospective inclusion :\n\n* Patient treated with CAR-T from 1 July 2018 under temporary authorization (ATU) or covered by French health insurance system (under post-ATU or MA) in a qualified center before activation of this register in this center\n* If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive\n\nProspective inclusion :\n\n* Patient eligible for a treatment with CAR-T for an hematological malignancy which is covered by French health insurance (for ATUs \u002F post-ATUs or MA), or as part of a clinical trial with the same indication, after the activation of this register in this center.\n* Patient whose CAR-T indication has been validated during a multidisciplinary tumor board (RCP) of a qualified center, according to the ministerial order of 8 August 2019\n* Patient deemed eligible for a treatment with CAR-T after a medical exam performed in a qualified center according to the ministerial order of 8 August 2019\n* If the patient is alive, the patient has been informed of the collection and use of their data, and the patient has not opposed this use. If the patient has died, the patient did not opposed the use of their data while alive.\n\nExclusion Criteria Patient not registered with the social security in France","0 Years","99 Years",{"count":181,"type":21},5000,"15 Years","This study is a registry including prospective and retrospective data on all patients who have been presented in a Multidisciplinary tumor board or RCP to be eligible for CAR-T cell treatment.",[185],"Hematopathology Eligible or CAR-t Cell Treatment","2026-03-02",{"date":188,"type":37},"2026-03-04",{"date":190,"type":37},"2019-12-19",{"date":192,"type":21},"2038-12-19",{"name":43,"class":44},36,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":224,"locationsCount":225},"100594385","phase-1-a-platform-trial-evaluating-new-drugs-or-combination-in-rr-peripheral-t-cell-lymphomas-100594385","NCT07018752","A Platform Trial Evaluating New Drugs or Combination in R\u002FR Peripheral T-cell Lymphomas","A Platform Trial, Evaluating New Drugs or Combination in Relapsed or Refractory Peripheral T-cell Lymphomas","PlaTform","1. Subject who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments\u002Fprocedures being conducted;\n2. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF);\n3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements;\n4. Subject with histologically proven peripheral T-cell lymphoma according to the criteria of the WHO classification 2017 or 2022 (subjects with mycosis fungoides, Sezary syndrome, lymphoblastic or large granular lymphocytic lymphoma will be excluded). Tumor tissue (initial diagnosis or relapse) should be available for central pathology review and biological characterization;\n5. Subject in relapse\u002Frefractory situation;\n6. ECOG performance status 0 to 2, or 3 if thought to be related to lymphoma;\n7. Adequate bone marrow function as defined by:\n\n   * Absolute Neutrophil Count ≥ 1,5 x 10\\^9\u002FL (≥ 1 x 10\\^9\u002FL if related to lymphoma)\n   * Platelets ≥ 75 x 10\\^9\u002FL (≥ 50 x 10\\^9\u002FL if related to lymphoma)\n   * Hemoglobin ≥ 8 g\u002FdL;\n8. Anticipated life expectancy at least 3 months;\n9. Presence of disease specific criteria allowing response evaluation. Unless otherwise specified, such criteria include:\n\n   1. Baseline fluorodeoxyglucose PET-scan demonstrating at least one positive (FDG-avid) lesion;\n   2. and at least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extra nodal lesion, defined as \\> 1.0 cm in its longest dimension;\n10. Contraception:\n\n    * For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, at screening and within 24 hours prior to initiating study treatment. The WOCBP agree to abstain from becoming pregnant or breastfeeding, to remain abstinent (from heterosexual intercourse) or use at least one highly effective method of contraception and to refrain from donating eggs, during the treatment period (including periods of treatment interruption) and for at least the delay described in the sub-protocol for the concerned molecules;\n    * For men of reproductive potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use at least a condom as method of contraception with a non-pregnant female partner of childbearing potential or a pregnant female partner, and to refrain from donating sperm, during the treatment period (including periods of treatment interruption), and for at least the delay described in the sub-protocol for the concerned molecules;\n11. Subject covered by a social security system;\n12. Subject who understands and speaks one of the country official languages unless local regulation authorizes independent translators;\n\n    Additional inclusion criteria specific to Origina-ly-T sub-study:\n13. For anaplastic large cell lymphoma subjects: failed or ineligible or intolerant to brentuximab vedotin. For extranodal NK\u002FT-cells lymphoma: failed or ineligible or intolerant to asparaginase-containing regimen;\n\n    Additional inclusion criteria specific to Golcaza sub-study:\n\n13\\. Subject had local diagnosed (nodal) follicular helper T cell lymphoma according to WHO classification 2022 or ICC 2022 classification based on a surgical lymph node biopsy or needle core biopsy including any one of the following type:\n\n* angioimmunoblastic type (AITL)\n* follicular T cell type\n* not otherwise specified (NOS);\n\n  14\\. ECOG performance status 0 to 1 (supersedes criterium 6 of the Master protocol);\n\n  15\\. Subjects must have an international normalized ratio (INR) \\\u003C 1.5 x ULN and partial thromboplastin time (aPTT) \\\u003C 1.5 x ULN (for subjects not receiving therapy). Note: Subjects receiving therapy for a thromboembolic event that occurred \\> 3months prior to enrollment are eligible as long as they are on a stable regimen of anticoagulation with warfarin, low-molecular weight heparin, or other approved therapeutic anticoagulation or antiplatelet regimen;\n\n  16\\. Contraception (supersedes criterium 10 of the Master protocol):\n* For women of childbearing potential (WOCBP): must have a negative result for pregnancy test, 10 to 14 days prior to initiating study treatment and within 24 hours prior to initiating study treatment. WOCBP agree to abstain from becoming pregnant or breastfeeding and to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one highly effective method of contraception , at least 28 days before the first dose of study treatment , during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide, and 6 months after the last dose of azacitidine. Women must refrain from donating eggs during this same period;\n* For men: during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of golcadomide and 3 months after the last dose of oral 5-azacitidine male subjects must:\n\n  * With female partners of childbearing potential: use a condom associated with a highly effective method of contraception or remain abstinent (refrain from heterosexual intercourse)\n  * With pregnant female partners: use a condom or remain abstinent (refrain from heterosexual intercourse) Men must refrain from donating sperm during this same period;\n\nExclusion Criteria:\n\n1. Evidence of central nervous system involvement by lymphoma;\n2. Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study (according to the investigator's decision);\n3. Uncontrolled systemic fungal, bacterial, or viral infection;\n4. Known Hepatitis C Virus (HCV) or active Hepatitis B Virus (HBV) infection defined as subject with detectable viral load (respectively detectable viral RNA or detectable viral DNA);\n5. Active malignancy other than the one treated in this research, unless the subject has been free of the disease for 2 years (subjects with a history of a completely resected non-melanoma skin cancer or successfully treated for an in-situ carcinoma are eligible);\n6. Use of any standard or experimental anti-cancer drug therapy within 28 days or a minimum of 5 half-lives of the drug, whatever the shortest prior to first administration of study drug;.\n7. Subject taking corticosteroids within 14 days prior to first administration of study drug, unless administered at a cumulated dose equivalent of prednisone ≤ 20mg \u002Fday (within these 14 days);\n8. Subject with prior autologous hematopoietic cell transplantation (auto-HCT) ≤ 3 months prior to starting investigational product(s). If subject had autologous SCT (Stem Cell Transplant) \\> 3 months prior to the start of investigational product(s), any unresolved (Grade \\> 1) autologous SCT-related toxicity;\n9. Subject with prior allogeneic hematopoietic cell transplantation (allo-HCT) with either standard or reduced intensity conditioning ≤ 3 months prior to starting investigational product(s). If subject had allogeneic SCT \\> 3 months prior to the start of investigational product(s) and still has any unresolved situation including (Grade \\> 1) treatment-related toxicity and\u002For ongoing immunosuppressor therapy and\u002For more than mild (NIH consensus) chronic graft-versus-host disease;\n10. Subject with major surgery ≤ 14 days prior to starting investigational product(s). Subjects must have recovered from any clinically significant effects of recent surgery;\n11. Subject who has received prior localized anticancer therapy (eg. radiotherapy \\[including palliative radiotherapy\\]) ≤ 14 days prior to starting investigational product(s);\n12. Known or suspected hypersensitivity to active substance or to any of the excipients;\n13. Pregnant, planning to become pregnant, or lactating woman;\n14. Person deprived of his\u002Fher liberty by a judicial or administrative decision;\n\n    Exclusion criteria specific to Origina-ly-T sub-study:\n15. Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to HIV within the last 12 months\n16. Impaired renal function (calculated CKP-EPI, MDRD or Cockcroft-Gault Creatinine Clearance \\\u003C 30 ml\u002Fmin) or impaired liver function tests (serum total bilirubin level \\> 34 μmol\u002FL), except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) \\> 3 upper normal limits, unless elevated to up to 5 x ULN due to peripheral T-cells lymphoma);\n17. Significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association)\\], myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina);\n18. Prior exposure to PI3Kdelta inhibitor;\n19. Known or suspected allergies, hypersensitivity, or intolerance to Roginolisib or its excipients;\n20. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications;\n21. Subjects with a diagnosis of cutaneous T-cell lymphoma (CTCL);\n22. Prior solid organ transplantation;\n\nExclusion criteria specific to GolcAza sub-study:\n\n15\\. Evidence of positive HTLV1 serology;\n\n16\\. Positive HIV test at screening, with the following exception: individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to HIV within the last 12 months;\n\n17\\. Impaired renal function (calculated CKD-EPI, MDRD or Cockcroft-Gault Creatinine Clearance \\\u003C 30 ml\u002Fmin) or impaired liver function tests (serum total bilirubin level \\> 34 μmol\u002FL) except in case of Gilbert's Syndrome, or documented liver or pancreatic involvement by lymphoma, serum transaminases (AST or ALT) \\> 3 upper normal limits (except documented liver involvement by lymphoma);\n\n18\\. Prior exposure to golcadomide;\n\n19\\. Refractory to azacitidine;\n\n20\\. Significant cardiovascular disease \\[e.g., Objective Class C or D heart diseases (cf. Classes of Heart Failure \\| American Heart Association)\\], myocardial infarction ≤ 3 months prior to starting golcadomide, unstable angina pectoris ≤ 3 months prior to starting golcadomide), or complete left bundle branch or bifascicular block), congenital long QT syndrome, QTcF ≥ 470 msec on screening, persistent or clinically meaningful ventricular arrhythmias;\n\n21\\. Received strong CYP3A inhibitors, moderate CYP3A inhibitors, strong CYP3A inducers, moderate CYP3A inducers within 7 days prior to initiation of study treatment;\n\n22\\. Vaccinated with live, attenuated vaccines within 6 months of enrollment;\n\n23\\. Known or suspected allergies, hypersensitivity, or intolerance to azacitidine, golcadomide or its excipients;\n\n24\\. Any known malabsorption syndrome or disease associated with malabsorption.",{"count":204,"type":21},49,[206,24],"PHASE1","This study is a platform trial for the evaluation of new drugs or combination of drugs in relapsed or refractory peripheral T-cell lymphomas.\n\nThe objective of the study is to generate exploratory data on new drugs or combination of drugs to treat refractory\u002Frelapse peripheral T-cells lymphoma to better identify the population of interest and design future correct clinical trials.\n\nPrimary objectives of the different sub-studies :\n\n* phase 1 sub-studies: determine the safety and tolerability of escalating doses of the sub-study treatment\n* phase 2 sub-studies: identify drugs that will improve significantly the outcome in target patients Secondary objectives of both sub-studies: analyze the response rate, the clinical benefit rate, the progression-free survival, the duration of response, the time to next treatment or death, the overall survival, the rate of transplantation following study treatment and the safety profile of the drugs used",[209],"Peripheral T Cells Lymphoma (PTCL)",[211,212,213,214,215,216,217],"lymphoma","peripheral T cells lymphoma","roginolisib","azacitidine","refractory peripheral T-cells lymphoma","relapsed peripheral T-cells lymphoma","golcadomide","2026-02-09",{"date":220,"type":37},"2026-02-11",{"date":222,"type":37},"2025-08-20",{"date":41,"type":21},{"name":43,"class":44},20,{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":252},"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":236,"type":21},100,[24],"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.",[240],"Lymphoma, Mantle-Cell",[242,243,244,245],"POD24","BTKI failure","High risk","18 to 79 years",{"date":220,"type":37},{"date":248,"type":37},"2025-02-21",{"date":250,"type":21},"2032-03",{"name":43,"class":44},16,{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":259,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":262,"studyType":82,"phases":4,"briefSummary":263,"conditions":264,"keywords":266,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},"100379468","breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl-registry-100379468","NCT04220970","Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) Registry","Inclusion Criteria:\n\n* Adult patients with an anaplastic large cell lymphoma associated with breast implants\n\nExclusion Criteria:\n\n\\-","FEMALE",{"count":261,"type":21},150,"13 Years","Anaplastic large cell lymphoma associated with breast implants (BIA-ALCL) is a rare disease seen only in women with a breast implant.\n\nBecause of the low incidence of this disease and the peculiar histological subtype, French authorities, in accordance with the recommendations of an expert group, recommended the implementation of a BIA-ALCL case registry, in connection with a national Multidisciplinary meeting (Réunion de Concertation Pluridisciplinaire nationale de recours- RCP).\n\nThis registry is opened in France and in Belgium",[265],"Anaplastic Large Cell Lymphoma Associated With Breast Implants (BIA-ALCL)",[267],"BIA-ALCL","2026-01-12",{"date":270,"type":37},"2026-01-14",{"date":272,"type":37},"2017-06-07",{"date":274,"type":21},"2032-06-07",{"name":43,"class":44},31,""]