[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Italiana Linfomi - ETS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":696},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,45,73,109,140,174,201,221,247,278,309,328,356,377,404,433,458,486,522,544,571,591,621,645,669],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100627781","phase-2-study-with-glofitamab-in-patients-with-mcl-and-inadequate-response-or-relapse-following-car-t-cell-therapy-100627781",false,"NCT07453095","Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy","A Phase II, Multicenter Study of GlOfitamab in Patients With Mantle Cell Lymphoma and inaDequate Response or Relapse Following CAR T-cell Therapy (GOLD)","Inclusion Criteria:\n\n1. Able to provide written informed consent forms approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.\n2. Histologically confirmed MCL after CAR T-cells failure (CD20+ by flow cytometry or immunohistochemistry). Note: Availability of archival material is mandatory for the study to perform central pathology review. Central pathology confirmation is not required to start treatment.\n3. Age ≥ 18.\n4. Patients who received CAR T-cells therapy for R\u002FR MCL at least 30 days prior to signing the informed consent form and who meet one of the following situations:\n\n   * Stable disease (SD) or progressive disease (PD) up to D+90; after CAR T-cells infusion (from D+30 to D+90);\n   * Partial response (PR) at D+90 after CAR-T cells infusion;\n   * Relapsed disease at any time after CAR-T cells infusion.\n5. No persistent CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of severe neurotoxicity grade \\> 3\n6. Adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (hematological toxicities excepted).\n7. Adequate hematological counts are defined as follows:\n\n   * Absolute neutrophil count (ANC) \\> 1.0 x 109\u002FL unless due to bone marrow involvement by lymphoma;\n   * Platelet count ≥ 50.000\u002Fmm3 unless due to bone marrow involvement by lymphoma;\n   * Hemoglobin ≥ 8.0 g\u002FdL.\n8. Adequate renal function defined as follows:\n\n   \\- Creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula).\n9. Adequate hepatic function per local laboratory reference range as follows (unless due to lymphoma):\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN;\n   * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).\n10. Participants must be able to adhere to the study visit schedule and other protocol requirements.\n11. Life expectancy \\> 12 weeks.\n12. ECOG Performance Status of 0, 1, or 2.\n13. Women of childbearing potential must have a negative pregnancy test at screening.\n14. Women of childbearing potential must take necessary precautions to avoid pregnancy while receiving study treatments and for 2 months after the last dose of glofitamab, for 18 months after the last dose of obinutuzumab and for 3 months after the last dose of tocilizumab.\n15. Male patient with a female partner of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 2 months after the last dose of glofitamab, for 3 months after the last dose of obinutuzumab and for 2 months after the last dose of tocilizumab.\n\nExclusion Criteria:\n\n1. Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).\n2. Participants not able to give consent.\n3. History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:\n\n   * Grade ≥ 3 adverse events except for Grade 3 endocrinopathy managed with replacement therapy;\n   * Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation.\n4. Patients with history of macrophage activation syndrome (MAS) \u002F hemophagocytic lymphohistiocytosis (HLH).\n5. Allogeneic hematopoietic stem cell transplantation.\n6. History of progressive multifocal leukoencephalopathy (PML).\n7. History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n8. CNS involvement with lymphoma.\n9. Participant has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug.\n10. Cardiovascular disease \\[NYHA class ≥2\\].\n11. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.\n12. Evidence of other clinically significant uncontrolled condition(s) included, but not limited to:\n\n    1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;\n    2. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) require treatment. Note: participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA;\n13. HIV seropositivity.\n14. If female, the patient is pregnant or breast-feeding.","ALL","18 Years",{"count":19,"type":20},41,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy.",[26],"Mantle Cell Lymphoma",[26,28,29,30,31],"MCL","CAR T cell","Inadequate response","Relapse","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-25","ACTUAL",{"date":38,"type":36},"2026-06-05",{"date":40,"type":20},"2030-06-15",{"name":42,"class":43},"Fondazione Italiana Linfomi - ETS","OTHER",14,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100641676","neurocognitive-assessment-in-long-term-survivors-of-lymphoma-100641676","NCT07652476","Neurocognitive Assessment in Long-Term Survivors of Lymphoma","Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)","FIL_LymDeCo","Inclusion Criteria:\n\n* Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).\n* Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +\u002F- radiotherapy.\n* Age ≥ 25 and ≤ 55 at enrollment.\n* Patients between third and fifth year of follow-up after the end of the first line treatment.\n* Absence of signs or symptoms of disease relapse.\n\nExclusion Criteria:\n\n* Patients with CNS disease localization.\n* Patients that received brain\u002Fneuroaxis radiotherapy.\n* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.","25 Years","55 Years",{"count":56,"type":20},100,"OBSERVATIONAL","This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.\n\nThe assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.\n\nBased on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.",[60,61,62],"Classic Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)","Primary Mediastinal B Cell Lymphoma","NOT_YET_RECRUITING","2026-06-17",{"date":66,"type":36},"2026-06-22",{"date":68,"type":20},"2026-09",{"date":70,"type":20},"2028-03",{"name":42,"class":43},7,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100510652","phase-3-comparison-between-local-radiotherapy-alone-or-combined-with-obinutuzumab-in-early-stage-follicular-lymphoma-the-gazebo-trial-from-the-fondazione-italiana-linfomi-100510652","NCT05929222","Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi","An Open-label, Randomized Phase III Trial Comparing Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi","FIL_GAZEBO","Inclusion Criteria:\n\n1. Histological documented diagnosis of Follicular Lymphoma grade I-IIIA as defined in the 2017 edition of World Health Organization (WHO)\n2. Ann Arbor Stage IA or IIA (includible in one radiation field), or IE, non-bulky (\\\u003C7 cm). Stage must be determined by PET\u002FCT scan (Appendix 2)\n3. Patients performing PET before surgery can also be enrolled without repeating PET after surgery\n4. No previous treatment except for steroid pre-treatment\n5. FLIPI \\\u003C 2, FLIPI2 ≤ 2\n6. Age ≥ 18 years\n7. Negative bone marrow biopsy\n8. Qualitative\u002Fquantitative PCR centralized assessment of BCL2\u002FIGH positive cells in peripheral blood (PB), bone marrow (BM).\n9. Centralized revision of the lymph node biopsy with FISH for t(14;18)\n10. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2\n11. At least one site of measurable nodal disease pre-biopsy ≥ 2.0 cm in the longest transverse diameter as determined by CT scan or ultrasonography\n12. Adequate renal function defined as follows:\n\n    * Creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)\n13. Adequate hepatic function per local laboratory reference range as follows:\n\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x UNL\n    * Bilirubin ≤1.5 x UNL (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n14. Subject understands and voluntarily signs an informed consent form approved by an Independent National Ethics Committee (NEC), prior to the initiation of any screening or study-specific procedures\n15. Subject must be able to adhere to the study visit schedule and other protocol requirements\n16. Life expectancy ≥ 3 months\n17. Fertility and pregnancy prevention criteria\n\n    * Women must be:\n\n      * postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months)\n      * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),\n      * completely abstinent (periodic abstinence from intercourse is not permitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study. They must also be pre-pared to continue birth control measures for at least 18 months after terminating treatment.\n    * Women of childbearing potential must have a negative pregnancy test at screening\n    * Men with female partners of childbearing potential: men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 3 months after the last dose of study treatment. Men must refrain from donating sperm for the same period\n    * Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following\n\n      * practice effective barrier contraception during the entire study treatment period and through 3 months after the last dose of study drug, or\n      * agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner\\] and withdrawal are not acceptable methods of contraception)\n\nExclusion Criteria:\n\n1. Histological diagnosis of Follicular lymphoma grade IIIb\n2. Staging \\>II or B symptoms or bulky disease (\\> 7 cm)\n3. Stage II with distant involved sites, not includible in a single radiation field\n4. Primary cutaneous follicular lymphoma\n5. Known HIV positivity\n6. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RNA on the same sample to confirm the result, if negative, the patient is eligible.\n7. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a quantitative HBVDNA test will be performed and if positive the subject will be excluded. Patients with HBcAb positivity and negative HBV DNA should be prophylactically treated with oral Lamivudine (100 mg \u002Fday). Note: subjects with serologic evidence of prior vaccination to HBV (i.e., hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n8. Central Nervous System (CNS) involvement with lymphoma\n9. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n10. Any history of other active malignancies within 3 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent\n11. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n    * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment.\n12. If female, the patient is pregnant or breast-feeding\n13. Patients participating in other clinical studies.",{"count":82,"type":20},190,[84],"PHASE3","Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinutuzumab.",[87],"Follicular Lymphoma",[89,90,91,92,93,94,95,96,97,98,99],"Lymphoma","Follicular","Immunotherapy","FL","Radiotherapy","Early","Localized","Obinutuzumab","MRD","Minimal residual disease","PET","2026-05-29",{"date":102,"type":36},"2026-06-01",{"date":104,"type":36},"2023-12-14",{"date":106,"type":20},"2031-04",{"name":42,"class":43},49,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100432756","phase-2-study-to-evaluate-combined-treatment-of-daratumumab-bortezomib-and-dexamethasone-in-pbl-patients-100432756","NCT04915248","Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.","An Open Label, Phase 2 Study to Evaluate Activity and Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Plasmablastic Lymphoma (DALYA Trial)","FIL_DALYA","Inclusion Criteria:\n\n1. Histologically confirmed plasmablastic lymphoma according to WHO 2017, CD38-positive by immunohistochemistry (≥5% of positive cells) Local diagnosis of PBL and local CD38 assessment ≥5% will suffice for enrollment and start of treatment.\n2. Patients with plasmablastic lymphoma relapsed or refractory:\n\n   * after at least one line of conventional-dose chemotherapy followed or not by autologous stem cell transplantation;\n   * after at least one line of conventional-dose chemotherapy and not eligible for salvage autologous or allogeneic transplantation;\n3. ECOG Performance Status ≤ 3;\n4. Age ≥ 18 years;\n5. Both HIV-negative and HIV-positive patients are eligible;\n6. HIV infection responsive to ongoing cART (combination antiretroviral therapy);\n7. At least one measurable disease lesion identifiable by imaging:\n\n   * A nodal lesion must be at least 11 mm x 11 mm OR ≥ 16 mm in the greatest transverse diameter (regardless of short axis measurement).\n   * An extranodal lesion must be at least 10 mm x 10 mm.\n8. Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 7 months (for women) o 4 months (for men) after last administration of bortezomib or 6 months after last daratumumab dose, regardless of sex. A woman is considered of childbearing potential, i.e., fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control method (failure rate of less than 1%) e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, and sexual abstinence. The use of condoms by male patients is required unless the female partner is permanently sterile.\n\n   WOCBP must have two negative pregnancy tests as verified by the study doctor prior to starting study therapy and must agree to undergo monthly pregnancy testing during the course of the study and after end of study therapy if clinically indicated. This applies even if the subject practices complete abstinence from heterosexual contact.\n9. Subject understands and voluntarily signs and dates an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures\n10. Subject must be able to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n1. Histologic diagnosis different from confirmed plasmablastic lymphoma according to WHO 2017 and\u002For CD38 expression \\\u003C 5% of positive cells\n2. CNS involvement\n3. Patients with known hypersensitivity to the investigational drug or to product components or severe allergic or anaphylactic reactions to humanized products\n4. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy including targeted small molecule agents within 14 days prior to the first dose of study drug\n5. Concomitant Kaposi sarcoma; however, patients with only skin involvement of KS can be included.\n6. Subject is:\n\n   * Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]. Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[HBcAb\\] ± antibodies to hepatitis B surface antigen \\[HBsAb\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (HBsAb positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR\n   * Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response \\[SVR\\], defined as aviremia at least 12 weeks after completion of antiviral therapy)\n7. Any history of another cancer during the last 5 years with the exception of non-melanoma skin tumors, in situ cervical carcinoma, or in situ breast cancer treated with curative intent with no history of metastatic disease.\n8. Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis or tuberculosis. Drugs for HIV treatment are allowed, as per local investigator prescription.\n9. Active ongoing infection from SARS-CoV-2.\n10. Screening laboratory values (due to causes different than lymphoma):\n\n    * Absolute neutrophil count (ANC) \\\u003C1.0 x 109\u002FL (unless secondary to documented marrow involvement by lymphoma)\n    * Platelet count \\\u003C75 x 109\u002FL\n    * Hemoglobin \\\u003C 7.5 g\u002FdL\n    * Alanine aminotransferase (ALT) and\u002For Aspartate aminotransferase (AST) \\> 3.5 times the upper limit of normal (ULN)\n    * Alkaline phosphatase \\> 3.5 times ULN\n    * Bilirubin \\> 2 times x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n    * Serum Creatinine Clearance \\\u003C 20 ml\u002Fh\n11. Subject has clinically significant cardiac disease, including:\n\n    * Myocardial infarction within 6 months before date of registration, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III-IV)\n    * Cardiac arrhythmia (Common Terminology Criteria for Adverse Events \\[CTCAE\\] current version Grade 2 or higher) or clinically significant ECG abnormalities. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \\> 470 msec\n12. Evidence of any other clinically significant uncontrolled condition(s)\n13. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n14. Breastfeeding women or women with a positive pregnancy test at screening",{"count":118,"type":20},28,[23],"It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.",[122],"Plasmablastic Lymphoma",[124,125,126,127,128,129,130,131],"Relapsed","Refractory","Plasmablastic","lymphoma","PBL","Daratumumab","Bortezomib","Dexamethasone",{"date":133,"type":36},"2026-06-02",{"date":135,"type":36},"2022-07-11",{"date":137,"type":20},"2027-07-01",{"name":42,"class":43},18,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},"100629548","geriatric-guided-care-versus-conventional-care-in-elderly-unfitfrail-patients-with-diffuse-large-b-cell-lymphoma-in-first-line-treatment-100629548","NCT07476105","Geriatric-guided Care Versus Conventional Care in Elderly Unfit\u002FFrail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment","Geriatric-guided Care Versus Conventional Care in Elderly Unfit\u002FFrail Patients With Diffuse Large B-cell Lymphoma in First Line Treatment. The Elderly Project 2.0: Non-randomized Cluster Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of DLBCL or Follicular Lymphoma (FL) grade IIIB.\n2. Age ≥ 70 years.\n3. UNFIT or FRAIL status according to sGA evaluated by the onco-hematologist at baseline.\n4. Patients eligible to a curative intent standard first line chemoimmunotherapy.\n5. Ability to understand and willingness to comply with study procedures.\n6. Signature of a written informed consent.\n\nExclusion Criteria:\n\n1. Patients not meeting at least one of the inclusion criteria listed above.\n2. Refuse to sign a written informed consent.","70 Years",{"count":149,"type":20},170,[151],"NA","The aim of this multicenter, non-randomized, cluster controlled trial study is to evaluate the impact of a geriatric-guided approach with a pro-active rehabilitative\u002Fnutritional plan for elderly unfit\u002Ffrail DLBCL patients eligible for receiving chemoimmunotherapy according to the sGA, versus a conventional approach with onco-hematological treatment alone.\n\nA key innovation element of this project is to use a geriatric-guided approach to improve the global management of all frailty aspects (nutritional, functional, cognitive, social), chasing a better tolerance and completion rate of treatment, tailoring safety and efficacy of therapies in unfit\u002Ffrail DLBCL patients.\n\nThis study may lead to a personalized approach for elderly DLBCL patients, taking into account a multidisciplinary and fully-integrated program, with the primary aim of improving the quality of life of patients and their families.",[154,155],"Diffuse Large B Cell Lymphoma","Follicular Lymphoma Grade 3B",[154,155,157,158,159,160,161,162,163,164],"unfit","frail","cluster","R-CHOP","geriatric","sGA","elderly","caregiver","2026-04-14",{"date":167,"type":36},"2026-04-15",{"date":169,"type":20},"2026-05",{"date":171,"type":20},"2029-05",{"name":42,"class":43},24,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100628874","bv-chp-real-life-and-biological-evidences-in-patients-with-salcl-100628874","NCT07467317","BV-CHP Real-life and Biological Evidences in Patients With sALCL","FIL_BREAL: BV-CHP Real-life and Biological Evidences in Patients With sALCL","FIL_BREAL","Inclusion Criteria:\n\n* Age ≥18 years;\n* Histological diagnosis of sALCL (ALK positive and ALK negative);\n* Have received BV-CHP as front-line therapy in real life setting;\n* Availability of histological material of initial ALCLs diagnosis: a FFPE block from an excisional\u002Fincisional biopsy must be provided for patient enrollment. FNAB and GNAB will not be considered for the study;\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Histological diagnosis other than sALCL;\n* Front line treatment other than BV-CHP;\n* Patients treated with BV-CHP in the contest of a clinical trial;\n* Refuse to sign a written informed consent.",{"count":56,"type":20},"Systemic Anaplastic Large Cell Lymphomas (sALCL) are rare lymphomas for which the cooperation in the collection of biological and clinical data is necessary to improve knowledge on the disease. The addition of a targeted therapy to chemotherapy recently showed to be effective compared to standard chemotherapy. First-line therapy brentuximab vedotin-CHP for sALCL was recently approved in Italy following the published 5-year data from the ECHELON-2 study. Correlations with biological parameters are missing.\n\nWithin the framework of the FIL, Investigators will assess the clinical outcomes-specifically response rates, progression-free survival (PFS), safety-in a retrospective cohort of patients diagnosed with sALCL and treated frontline with BV-CHP in the real-life setting. These outcomes will be correlated with data derived from PET\u002FCT imaging and lymph node biological samples.\n\nFurthermore, Investigators will collect lymph node samples of patients diagnosed with sALCL and treated with BV-CHP at FIL Centers. The study will investigate the prognostic relevance of known molecular alterations (e.g., DUSP22, TP63). Through whole-exome sequencing and transcriptomic profiling, recurrent genetic alterations will be explored, as well as the cell of origin and the tumor microenvironment of sALCL, with particular attention to cell-to-cell interactions. A machine learning model will be validated to identify DUSP22 rearrangements from hematoxylin\\&eosin (H\\&E)-stained slides. Finally, integrated analysis of omics and clinical data using AI will aim to uncover biological signatures predictive of treatment response.",[185],"Anaplastic Large Cell Lymphoma",[185,187,188,189,190,191,192],"ALK","DUSP22","TP63","BV-CHP","Brentuximab vedotin","sALCL","2026-03-27",{"date":195,"type":36},"2026-03-30",{"date":169,"type":20},{"date":198,"type":20},"2028-05",{"name":42,"class":43},19,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":218,"leadSponsor":219,"locationsCount":220},"100628603","neurocognitive-assessment-in-adults-undergoing-cd19-targeted-car-t-cell-therapy-100628603","NCT07463781","Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy","Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy: a Multicenter Observational Prospective Study","NEURO_CAR-T","Inclusion Criteria:\n\n* Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High- Grade B Cell Lymphoma (DLBCL\u002FHGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL).\n* Patients undergoing CD19-targeted CAR-T cell salvage therapy for relapsed\u002Frefractory disease according to AIFA inclusion criteria.\n* Age over 18-years-old at the time of lymphoma diagnosis.\n\nExclusion Criteria:\n\n* Patient with histological diagnosis of mantle cell lymphoma (MCL) or acute lymphoblastic leukemia (ALL)\n* Patients with CNS disease localization.\n* Patients that received brain\u002Fneuroaxis radiotherapy.\n* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.",{"count":56,"type":20},"This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.",[61,212,213],"High Grade B Cell Lymphoma","Primary Mediastinal B-cell Lymphoma (PMBCL)","2026-03-11",{"date":216,"type":36},"2026-03-13",{"date":169,"type":20},{"date":171,"type":20},{"name":42,"class":43},8,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":173},"100553957","phase-2-study-with-mosunetuzumab-and-zanubrutinib-in-rr-follicular-lymphoma-patients-100553957","NCT06492837","Study With Mosunetuzumab and Zanubrutinib in R\u002FR Follicular Lymphoma Patients","A Phase II Trial Investigating MOsunetuzumab and ZAnubrutinib (BGB-3111) in Relapsed\u002FrefracTory Follicular Lymphoma Patients (MOZART)","FIL_MOZART","Inclusion Criteria:\n\n1. Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.\n2. Histologically documented diagnosis of cFL (CD20+ by flow cytometry or immunohistochemistry) as defined in the International Consensus Classification of Mature Lymphoid Neoplasms (Campo E., 2022) and in the World Health Organization Classification (WHO) 5th edition 2022.\n3. Age ≥18 years.\n4. Relapsed or refractory disease. Histologic confirmation of FL relapse is not mandatory but is highly recommended.\n5. At least one and up to three lines of systemic therapy containing an anti-CD20 antibody (anti-CD20 alone and\u002For in combination with radiotherapy is not considered as a line of therapy).\n6. FL requiring systemic therapy assessed by investigator based on tumor size and\u002For Groupe d'Etude des Lymphomes Folliculaires criteria.\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.\n8. Availability of histological material for centralized revision. Central pathology review is not mandatory for start of treatment.\n9. At least one measurable or evaluable site of disease at relapse as documented by CT scan (nodes ≥ 1.5 cm in the longest transverse diameter) or FDG-PET (avid FDG sites). Note: MRI is allowed only if CT scan cannot be performed. Patients with exclusive bone marrow involvement are eligible.\n10. Adequate hematological counts defined as follows:\n\n    * Absolute neutrophil count (ANC) \\> 1.0 x 109\u002FL;\n    * Platelet count ≥ 75 x 109\u002FL;\n    * Hemoglobin ≥ 9 g\u002FdL.\n11. Adequate renal function defined as creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula, normalized to 1.72 m2).\n12. Adequate hepatic function per local laboratory reference range as follows:\n\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN;\n    * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin).\n13. Subject must be able to adhere to the study visit schedule and other protocol requirements.\n14. Subject must be able to swallow capsules or tablets.\n15. Women must be:\n\n    * postmenopausal for at least 1 year (must not have had a natural menses for at least 12 months);\n    * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy);\n    * if they are childbearing potential, completely abstinent (periodic abstinence is not permitted) or if sexually active, be practicing a highly effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g.: condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization), before entry, and must agree to continue to use the same method of contraception throughout the study and for 30 days after receiving the last dose of zanubrutinib and 3 months after receiving the last dose of mosunetuzumab.\n16. Women of childbearing potential must have a negative pregnancy test at screening.\n17. Men must agree to use an acceptable method of contraception for the duration of the study and for 1 week after receiving the last dose of study drug.\n18. Male even if surgically sterilized (i.e., status post vasectomy) must agree to 1 of the following:\n\n    * practice effective barrier contraception (e.g.: condoms) , or\n    * agree to practice abstinence, when this is in line with the usual lifestyle of the subject (periodic abstinence is not permitted).\n\nExclusion Criteria:\n\n1. Histological diagnosis different from cFL (Campo E., 2022).\n2. R\u002FR FL who were treated with more than three lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy; rituximab maintenance as part of a previous line of therapy should not be considered as a line of therapy; radiotherapy alone or in combination with rituximab is not considered a line of therapy).\n3. Patients with stage I or II (limited stage) suitable for RT alone treatment.\n4. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor (BTKi).\n5. Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).\n6. Need of anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon). Requires ongoing treatment with a strong CYP3A inducer.\n7. Evidence or any history of transformation from FL to other aggressive histology.\n8. Prior allogeneic hematopoietic stem cell transplantation.\n9. History of severe bleeding disorder (G\\>3), or history of spontaneous bleeding requiring blood transfusion or other medical intervention. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug\n10. Life expectancy \\\u003C 6 months.\n11. History of progressive multifocal leukoencephalopathy (PML).\n12. History of hemophagocytic lymphohistiocytosis (HLH) or chronic active EBV.\n13. History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n14. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening as confirmed by mandatory brain computed tomography (CT) scan and, if clinically indicated, by lumbar puncture.\n15. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug. If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 10 mg (or equivalent).\n16. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 90 days prior to first therapy administration.\n17. Any uncontrolled or significant cardiovascular disease \\[NYHA class ≥2\\].\n\n    1. Myocardial infarction within 6 months before screening\n    2. Unstable angina within 3 months before screening\n    3. New York Heart Association class III or IV congestive heart failure\n    4. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n18. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.\n19. Any history of other active malignancies within 3 years prior to study entry, except for adequately treated in situ carcinoma of the uterine cervix, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, non-muscle-invasive bladder cancer, localized Gleason score 6 prostate cancer, previous malignancy confined and surgically resected with curative intent.\n20. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n    1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;\n    2. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA;\n21. HIV seropositivity.\n22. Pregnant or lactating women. If female, the patient is pregnant or breast-feeding.\n23. Severe or debilitating pulmonary disease.\n24. 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.\n25. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of toxicity or AEs.\n26. Major surgery within 4 weeks of the first dose of study drug.\n27. Vaccination or requirement for vaccination with a live vaccine within 28 days prior to the first dose of study drug or at any time during planned study treatment.\n28. Ongoing alcohol or drug addiction or any psychiatric condition(s) which would compromise ability to comply with study procedures.\n29. Hypersensitivity to zanubrutinib or mosunetuzumab or any of the other ingredients of the applicable study drugs.\n30. Active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (eg, idiopathic thrombocytopenia purpura).",{"count":230,"type":20},56,[23],"This is a Phase 2, multicenter study evaluating the efficacy and safety of mosunetuzumab + zanubrutinib (M+Z) used as salvage strategy in patients with R\u002FR FL who have received at least one line of prior systemic therapy.",[87],[235,236,237,238],"Follicular lymphoma","Mosunetuzumab","Zanubrutinib","Relapsed\u002Frefractory follicular lymphoma","2026-01-26",{"date":241,"type":36},"2026-01-28",{"date":243,"type":36},"2024-10-23",{"date":245,"type":20},"2033-09-15",{"name":42,"class":43},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":21,"phases":258,"briefSummary":260,"conditions":261,"keywords":263,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100462332","phase-1-study-of-atezolizumab-plus-begev-regimen-in-relapsed-or-refractory-hodgkins-lymphoma-patients-100462332","NCT05300282","Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients","A Phase I\u002FII b (Randomized Controlled) Study of Atezolizumab Combined to BEGEV Regimen as First Salvage Treatment in Patients With Relapsed or Refractory Hodgkin's Lymphoma Candidate to Autologous Stem-Cell Transplantation","FIL_A-BEGEV","Inclusion Criteria:\n\n* 18-60 years old (upper limit valid only for phase I).\n* Histologically confirmed cHL, at first disease relapse or refractory to a first-line treatment or with documented persistent disease at interim positron emission tomography (PET) performed after 2 cycles of first line (ABVD\u002FABVD like\u002FBEACOPP).\n* Only one prior systemic therapy for Hodgkin's lymphoma (HL).\n* First disease relapse or refractory to a first-line treatment.\n* Eligibility for ASCT.\n* Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale.\n* Adequate haematological function, unless abnormalities due to underlying disease, at the moment of signing informed consent, defined as follows:\n\n  * neutrophils \\> or = 1.500\u002Fmmc and\n  * platelets \\> or = 75.000\u002Fmmc and\n  * haemoglobin \\> or = 8,0 g\u002FdL with transfusion independence\n* Capacity and willingness to adhere to study visit schedule and specific protocol procedures.\n* Compliance with effective contraception without interruption, according to physician's judgement, from 28 days before treatment start up to at least 6 months after treatment discontinuation, agreeing not to donate semen\u002Feggs during treatment and for at least 6 months after last treatment dose.\n\nExclusion Criteria:\n\n* More than one prior systemic therapy for HL.\n* Presence of autoimmune disease (based on medical history): systemic lupus erythematosus, autoimmune thyroid disease (Hashimoto's thyroiditis, Basedow's disease), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis (includine bronchiolitis obliterans organizing pneumonia) and inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n* Previous skin toxicity (i.e. Steven-Johnson Sdr, severe skin reactions.\n* Prior allogeneic stem cell transplantation or prior solid organ transplant.\n* History of active tubercolosis.\n* History of leptomeningeal disease.\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment.\n* Central nervous system (CNS) involvement by lymphoma.\n* Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent.\n* Seropositivity for HBV or evidence of active infection. The following categories may be considered for the study:\n\n  * HBsAg positive with HBV DNA \\\u003C 2000 UI\u002Fml (inactive carriers); HBV DNA \\> 2000 UI\u002Fml is criteria of exclusion\n  * HBsAg negative but HBsAb positive\n  * HBsAg negative but HBcAb positive HBsAg positive with HBV DNA \\\u003C 2000 UI\u002Fml and HBsAg negative but HBcAb positive will be eligible for the study only if they accept to receive antiviral prophylaxis for all the period of treatment and at least for 12 months after the end of therapy. Treatment should be stopped in case of hepatitis reactivation. - Seropositivity for HCV. Patients with presence of HCV antibody are eligible only if PCR result are negative for HCV RNA\n* Seropositivity for HIV.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail bed) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics except if for tumor fever) within 2 weeks of the start of Cycle 1.\n* Life expectancy lower than 6 months.\n* Prior history of malignancies, other than HL, unless the patient has been free for at least 5 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix).\n* Any of the following laboratory abnormalities: liver enzymes (AST\u002FSGOT and\u002For ALT\u002FSGPT) \\> 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin \\> 1.5 mg\u002FdL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance \\\u003C 30 mL\u002Fmin.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception (one negative pregnancy test within 14 days prior to initiation of study treatment required).\n* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study.\n\nException to Exclusion:\n\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n* Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n* Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  * Rash must cover \\\u003C 10% of body surface area\n  * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n  * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.","60 Years",{"count":257,"type":20},122,[259,23],"PHASE1","The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule.\n\n6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles.\n\nPatients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT.\n\nThe phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm):\n\n1. arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR.\n2. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks.\n\nAfter the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months.",[262],"Relapsed or Refractory Hodgkin's Lymphoma",[264,265,266,267,268,269,270],"Hodgkin's lymphoma","atezolizumab","BEGEV","phase I\u002FII b study","relapsed","refractory","MTD",{"date":241,"type":36},{"date":273,"type":36},"2023-02-27",{"date":275,"type":20},"2030-04-27",{"name":42,"class":43},32,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100511026","lifestyles-implemented-survivorship-care-plan-in-lymphoma-survivors-100511026","NCT05934084","Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors","Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors: A Randomized Non-pharmacological Clinical Trial By The Fondazione Italiana Linfomi (FIL)","Inclusion Criteria:\n\n* Age 18-50 at initial treatment;\n* Diagnosis of classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL) or Primary mediastinal large B-cell lymphoma (PMBCL);\n* Patients in Complete Remission (CR) after first-line therapy \\[ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, doxorubicin , cyclophosphamide, vincristine, procarbazine and prednisone) or ABVD-BEACOPP Pet-2 guided treatment for cHL; R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine and prednisone) for DLBCL; R-CHOP or R-DA-EPOCH (rituximab- Dose Adapted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) for PMBCL);\n* Patients in remission for a minimum 3 years since the last treatment and a maximum of 10 years;\n* Cumulative doxorubicin\u002F adriamycin dose received of at least 200 mg\u002Fmq (4 cycles of chemotherapy);\n* Availability echocardiogram (ECG) and 2D-STE-echocardiography (Two-dimensional speckle strain echocardiography) performed no later than three months prior to enrollment;\n* Signature of a written informed consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate voluntarily in the study.\n\nExclusion Criteria:\n\n* Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers and adequately treated cone-biopsied in situ carcinoma of the cervix;\n* Second line chemotherapy of stem cell transplant;\n* Not able to perform physical activity;\n* Grade \\>\u002F=3 neuropathy;\n* Vertebral fractures or stenosis of the vertebral canal; other bone fracture;\n* Cardiovascular disease: arrhythmia \\>\u002F= grade 2, hypertension \\>\u002F grade 2, left ventricular dysfunction \\>\u002F= grade 2 pericardial disease\u002Feffusion any grade, myocarditis any grade, pulmonary hypertension any grade, restrictive cardiomyopathy any grade valvular hearth disease \\>\u002F= grade 2, right ventricular dysfunction \\>\u002F= grade 2;\n* Venous thromboembolism or arterial thrombosis during last 6 months;\n* Hemorrhage\u002F bleeding \\>\u002F= grade 2 during last 6 months;\n* Chronic lymphedema (arms and\u002F or limbs);\n* Rheumatic disease or inflammatory bowel disease in systemic treatment;\n* Any pleural effusion;\n* If female, the patient is pregnant;\n* Unwilling to comply to all required visits and procedures for the duration of study participation","50 Years",{"count":287,"type":20},552,[151],"This is a prospective randomized open-label, multicenter, 2-arm study to assess the role of healthy LifeStyle implemented Survivorship Care Plan (LS-SCP) in modifying the Quality of Life (QoL) in a population of long-term lymphoma survivors (in remission for a minimum 3 years since the last treatment and a maximum of 10 years).",[291,61,292],"Classical Hodgkin Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[294,295,296,297,298,299],"Survivorship Care Plan","Lifestyles implemented-Survivorship Care Plan","Quality of Life","Lymphoma Survivors","Nutritional plan","Physical activity","2026-01-09",{"date":302,"type":36},"2026-01-12",{"date":304,"type":36},"2024-02-26",{"date":306,"type":20},"2026-02-01",{"name":42,"class":43},40,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100479539","quality-of-life-on-elderly-patients-with-low-grade-non-hodgkin-lymphoma-100479539","NCT05524298","Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma","Quality Of Life On Elderly Patients With Low Grade Non-Hodgkin Lymphoma Treated With Immunotherapy Or Immunochemotherapy And\u002FOr Radiotherapy: An Observational Prospective Study Of The Fondazione Italiana Linfomi","Inclusion Criteria:\n\n* Local histological diagnosis of indolent B cell non-Hodgkin lymphoma: follicular lymphoma, marginal zone lymphoma (nodal, MALT (Mucosa-Associated Lymphoid Tissue), splenic), lymphoplasmacytic lymphoma\u002F Waldenström macroglobulinemia)\n* Age ≥ 70 years\n* Patient candidates to receive treatment for lymphoma\n* Patient previously untreated for lymphoma\n* Evaluation of Comprehensive Geriatric Assessment at baseline\n* Ability to provide informed consent: subject understands and voluntarily signs an informed consent form approved by an IEC (Independent Ethics Committee), prior to registration into the study\n\nNote: Patient treated in the context of a clinical trial is admitted\n\nExclusion Criteria:\n\n* none",{"count":317,"type":20},150,"Aims of this study are to describe the variation of QoL (Quality of Life) during the clinical management of low-grade lymphoma in elderly subjects and to identify the most important factors at diagnosis and during treatment with an impact on QoL (Quality of Life).",[320],"Low Grade Non-Hodgkin's Lymphoma, Adult",{"date":302,"type":36},{"date":323,"type":36},"2022-12-07",{"date":325,"type":20},"2026-02",{"name":42,"class":43},20,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":327},"100580302","phase-2-a-combination-of-rituximab-and-cc-99282-as-front-line-therapy-for-older-frail-patients-with-diffuse-large-b-cells-non-hodgkin-lymphoma-evaluated-with-a-simplified-geriatric-assessment-sga-a-phase-ii-study-of-the-fondazione-italiana-linfomi-fil-100580302","NCT06835530","A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)","FIL_RICCO","Inclusion Criteria:\n\n1. Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study- specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.\n2. Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022)\n3. Previously untreated\n4. Frail patients defined as follows (Appendix A-D): Age ≥ 80 years: activity of daily living (ADL) \\\u003C 6 residual functions and\u002For Instrumental activity of daily living (IADL) \\\u003C 8 residual functions and\u002For cumulative illness rating scale (CIRS) \\> 5 comorbidities of grade 2 and\u002For one or more comorbidities of grade 3-4\n5. Patient not eligible to anthracycline-based chemotherapy\n6. Ann Arbor Stage I - IV (Appendix E)\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3 (Appendix F)\n8. At least one site of measurable nodal disease at baseline \\[≥ 1.5 cm\\] in the longest transverse diameter as determined by CT scan\n9. Adequate hematological counts defined as follows:\n\n   * WBC \\> 2.5 x 109\u002FL with ANC \\> 1.0 x 109\u002FL unless due to bone marrow involvement by lymphoma\n   * Platelet count ≥ 75 x 109\u002FL unless due to bone marrow involvement by lymphoma\n   * Hemoglobin ≥ 10 g\u002FdL unless anemia related to active lymphoma\n10. Adequate renal function defined as creatinine clearance ≥ 30 mL\u002Fmin (Appendix G). The same CrCl cutoff applies in case of documented renal involvement by lymphoma\n11. Adequate hepatic function per local laboratory reference range, unless secondary to lymphoma, as follows:\n\n    * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 x ULN\n    * Bilirubin ≤ 2 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, i.e. mild and chronic hemolysis)\n12. Subject must be able to adhere to the study visit schedule and other protocol requirements\n13. Subject must be able to swallow capsules or tablets\n14. Life expectancy ≥ 3 months\n15. Male subjects must practice complete abstinence when this is in line with the usual lifestyle (periodic abstinence is not permitted) or agree to use specified contraceptive methods (barrier contraception: condom) during sexual contact with a female of childbearing potential while participating in the study, for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy. Furthermore, they do not have to donate sperm during the study and for at least 28 days after receiving the last dose of study drug. If applicable, male subjects must receive study specific Pregnancy Prevention Plan (PPP).\n\nExclusion Criteria:\n\n1. Histological diagnosis different from DLBCL\n2. Central nervous system (CNS) involvement with lymphoma\n3. Severe heart failure (NYHA grado III-IV and\u002For LVEF \\\u003C 45%), liver disease Child Pugh C, history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or pulse oximetry of \\\u003C 92% while breathing room air, or any other clinical condition that would preclude participation in the study or compromise ability to give informed consent\n4. Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent\n5. Gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy) or any other malabsorption condition\n6. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2\n   2. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative, may participate; patients with positive anti-HBc antibody from previous infection or inactive carriers are eligible only with HBV-DNA negative and with concomitant treatment with Lamivudine or Tenofovir\n   3. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA\n7. Human immunodeficiency virus (HIV) seropositivity\n8. Absence of caregivers in non-autonomous patients\n9. Allergy or intolerance to the active or inactive ingredients of study drugs","80 Years",{"count":337,"type":20},47,[23],"Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like) treatments.",[341],"Diffuse Large B Cell Non-Hodgkin Lymphoma",[343,344,345,346,347],"diffuse large B-cell non-Hodgkin lymphoma","simplified geriatric assessment (sGA)","rituximab","older frail patients","Golcadomide","2025-12-31",{"date":350,"type":36},"2026-01-02",{"date":352,"type":36},"2025-04-09",{"date":354,"type":20},"2030-04",{"name":42,"class":43},{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":376},"100502228","primary-cardiac-lymphoma-italian-multicenter-experience-100502228","NCT05819528","Primary Cardiac Lymphoma: Italian Multicenter Experience","Inclusion Criteria:\n\n* Diagnosis of PCL (any histotype) defined as an extranodal lymphoma involving only the heart with possible involvement of the pericardium.\n* Age ≥18 years.\n* Diagnosis histologically confirmed. Cytofluorimetry analysis of pericardial fluid showing phenotypic features consistent with a primary cardiac lymphoma is permitted if a biopsy sample is not feasible\u002Favailable for diagnosis; monoclonality is not accepted as a surrogate for diagnosis.\n* Date of diagnosis: from 1st January 2000 to 31st December 2020.\n* Only patients treated in first-line with chemoimmunotherapy regimens including an anti-CD20 monoclonal antibody are eligible for the study.\n* Signed written informed consent (in case of unreachable subject please see chapter 11.2)\n\nExclusion Criteria:\n\n* Secondary cardiac involvement from lymphoma; primary mediastinal lymphoma with pericardial infiltration or other lymphomas with involvement of the pericardium\u002Fthe heart by contiguity and primary effusion lymphoma are not included in this study.\n* Patients treated with chemotherapy regimens that did not include an anti-CD20 monoclonal antibody as first-line therapy.\n* Refuse to sign a written informed consent",{"count":363,"type":20},43,"The rationale of this study is to provide an overview on PCL (Primary Cardiac Lymphoma) in Italy, trying to shed light on unknown aspects of the disease and on unanswered questions about its management that could be helpful in clinical practice.",[366],"Primary Cardiac Lymphoma",[368],"PCL",{"date":370,"type":36},"2026-01-05",{"date":372,"type":36},"2024-10-02",{"date":374,"type":20},"2026-06",{"name":42,"class":43},17,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":21,"phases":387,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100458464","phase-2-consolidation-with-loncastuximab-tesirine-after-a-short-course-of-immunochemotherapy-in-btki-treated-or-intolerant-relapsedrefractory-mantle-cell-lymphoma-patients-100458464","NCT05249959","Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed\u002FRefractory Mantle Cell Lymphoma Patients.","Consolidation With ADCT-402 (Loncastuximab Tesirine) After a Short Course of Immunochemotherapy: a Phase II Study in BTKi-treated (or BTKi Intolerant) Relapsed\u002FRefractory (R\u002FR) Mantle Cell Lymphoma (MCL) Patients","FIL_COLUMN","Inclusion Criteria:\n\n* Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification\n* Age ≥ 18 and \\\u003C 85 years\n* Relapsed\u002FRefractory disease after one, two, three or four lines of treatment\n* Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen\n* Previous treatment with BTKi (Bruton Tyrosine Kinase inhibitors) monotherapy or BTKi containing regimens with R\u002FR disease; and\u002For patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment.\n* Previous treatment with any anti-CD19 agents is allowed (included CAR-T treatment) If previous anti-CD19 treatment has occurred, tissue CD19 expression must be assessed by histology or flow cytometry\n* Venetoclax treated patients are allowed.\n* Stem cell transplant eligible patients are allowed.\n* Measurable nodal or extranodal disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions. Note: Patients with bone marrow involvement only are eligible. In case of bone marrow infiltration only, bone marrow aspiration and biopsy are mandatory for all staging evaluations\n* ECOG (Eastern Cooperative Oncology Group)\u002FWHO (World Health Organization) performance status ≤ 2 (unless MCL-related)\n* The following laboratory values at screening (unless due to bone marrow involvement by lymphoma):\n\n  * Absolute Neutrophil count (ANC) \\> 1.0×109\u002FL\n  * Platelet count ≥ 75.000\u002Fmm3\n  * Creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)\n  * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (upper limit of normal)\n  * Bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non- hepatic origin)\n* Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures.\n* Subject must be able to adhere to the study visit schedule and other protocol requirements.\n* Life expectancy ≥ 3 months.\n* Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active.This applies for the time period between signing of the informed consent form and at least 10 months after last loncastuximab tesirine (ADCT-402) dose. Men with female partners who are of childbearing potential must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and at least 7 months after last loncastuximab tesirine (ADCT-402) dose.\n\nExclusion Criteria:\n\n* Subjects who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.\n* Known history of hypersensitivity to human antibodies.\n* Allogenic stem cell transplant within 6 months prior to start of first study drug.\n* Allogenic stem cell transplant with active \u002F uncontrolled graft-versus-host disease.\n* Previous treatment with CD19 targeting agents.\n* More than four lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy).\n* Active second malignancy in the last three years other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or any other tumor that the Sponsor and Coordinating Investigator agree and document should not be considered preclusive to participate in the study.\n* Major surgery or any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to start of study drug (R-BAC). A shorter interval in special settings must be approved by the Sponsor and\u002For Investigator.\n* Cardiovascular disease (NYHA, New York Heart Association, class ≥2).\n* Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n  * Uncontrolled and\u002For active systemic infection (viral including COVID 19, bacterial or fungal);\n  * Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note:\n\nsubjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR results (polimerase chain reaction) negative for HCV RNA.\n\n* HIV seropositivity.\n* Lymphoma with active CNS (central nervous system) involvement at the time of screening, including leptomeningeal disease.\n* Congenital long QT syndrome or a corrected QTcF interval of \\>480 msec at screening (unless secondary to pacemaker or bundle branch block).\n* Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk.\n* If female, the patient is pregnant or breast-feeding.","79 Years",{"count":108,"type":20},[23],"This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R\u002FR (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).",[390,391],"Relapsed Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma",[393,394,395,396],"Relapsed\u002FRefractory Mantle Cell Lymphoma (MCL)","ADCT-402 (loncastuximab tesirine)","BTKi (Bruton Tyrosine Kinase inhibitors) - treated","BTKi (Bruton Tyrosine Kinase inhibitors) intolerant",{"date":370,"type":36},{"date":399,"type":36},"2022-03-21",{"date":401,"type":20},"2029-03",{"name":42,"class":43},21,{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":385,"enrollmentInfo":412,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":414,"conditions":415,"keywords":418,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":327},"100561287","exploring-the-clinical-impact-of-myc-aberrations-and-their-relationship-with-microenvironment-in-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell-lymphoma-100561287","NCT06588205","Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma","Multicenter, Observational, Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma","FIL_MIMYC","Inclusion Criteria:\n\n* Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019\n* Presence of one MYC translocation or gain of copies (GCN: \\> 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH\n* Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67\n* Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified \"Burkitt like\" chemotherapies) as first-line therapy\n* Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.\n* Age between 18 and 79 years\n\nExclusion Criteria:\n\n* Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma\n* Have received palliative treatment",{"count":413,"type":20},200,"This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma",[154,416,417],"High-grade B-cell Lymphoma","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements",[154,416,419,420,421,422,423,424],"MYC","BCL2","BCL6","Double Hit","Triple Hit","lymphoma micro-environment","2025-12-22",{"date":427,"type":36},"2025-12-29",{"date":429,"type":36},"2025-05-05",{"date":431,"type":20},"2027-12",{"name":42,"class":43},{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":457},"100516758","a-prospective-observational-cohort-study-on-the-clinical-impact-of-novel-monoclonal-antibodies-in-b-cell-non-hodgkin-lymphoma-in-italian-clinical-practice-100516758","NCT06008691","A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice","A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian Clinical Practice","FIL_MAB","Inclusion Criteria:\n\n* Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory.\n* Patients aimed to be treated in indication with a \"novel\" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Being involved in a prospective interventional trial outside indication.\n* Patients treated outside approved indications:\n\n  * 648-approved indication.\n  * 5% AIFA support.\n  * Compassionate use.\n* Age less than 18 years.\n* Inability to provide an informed consent.",{"count":442,"type":20},1500,"This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.",[445],"Non-Hodgkin Lymphoma, B-cell",[447,448,449,450],"Non-Hodgkin Lymphoma","B-cell","monoclonal antibodies","novel antibodies",{"date":427,"type":36},{"date":453,"type":36},"2023-12-27",{"date":455,"type":20},"2038-10",{"name":42,"class":43},61,{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":467,"conditions":468,"keywords":469,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":485},"100502022","multilayer-biological-characterization-of-advanced-follicular-lymphoma-a-translational-study-from-filfoll12-trial-100502022","NCT05816850","Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial","FIL_FOLL-BIO","Inclusion Criteria:\n\n* Patient enrolled in the FIL\\_FOLL12 trial (documented by the signature of the study informed consent);\n* Availability of biological samples: bone marrow aspirate, peripheral blood and\u002For FFPE diagnostic sample (nodal or extranodal);\n\nExclusion Criteria:\n\n* None",{"count":466,"type":20},654,"This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated.",[87],[89,90,470,92,471,472,473,474,475,476,477,478],"Immunochemotherapy","Aberration","Mutation","EZH2","CHOP","Bendamustine","Biological","Rituximab","Biomarker",{"date":427,"type":36},{"date":481,"type":36},"2023-09-19",{"date":483,"type":20},"2027-06-01",{"name":42,"class":43},26,{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":21,"phases":496,"briefSummary":497,"conditions":498,"keywords":500,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":521},"100612636","phase-3-pet-guided-dose-reduction-for-involved-site-radiotherapy-in-early-stage-unfavourable-hodgkin-lymphoma-100612636","NCT07256158","PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma","PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma: a Randomized, Phase III, Non-inferiority studY (PRIORITY Study)","FIL_PRIORITY","Inclusion Criteria:\n\n* Age ≥18 years;\n* Histologically confirmed classical HL stage I, II unfavorable according to GHSG criteria;\n* Patient with any nodal mass ≥ than 10 cm can be included\n* No previous treatment for Hodgkin lymphoma;\n* ECOG performance status 0 to 2;\n* Presence of FDG-avid lymphoma lesions on baseline PET scan;\n* Subject understands and voluntarily signs the informed consent form approved by the Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures;\n* Adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count \\> 1.0 x109\u002FL\n  * platelet count \\> 75 x109\u002FL\n  * Total bilirubin \\\u003C 2 mg\u002Fdl without a pattern consistent with Gilbert's syndrome\n  * Aspartate Transaminase and Alanine Transaminase (AST\u002FALT) \\\u003C 3.0 X institutional Upper Limits of Normality (ULN)\n  * Creatinine within normal institutional limits or creatinine clearance \\> 50 mL\u002Fmin\n* Women of childbearing potential must agree to use a highly effective method of contraception (oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device) from the signature of informed consent until six months after the last dose of treatment;\n* Men must agree to use a highly effective method of contraception (barrier contraception or abstinence, when this is in line with the usual lifestyle of the subject) from the signature of informed consent until six months after the last dose of treatment;\n* Women of childbearing potential must have a negative serum pregnancy test at screening.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria are not eligible to enroll:\n* Stage II B- III- IV\n* Hodgkin Lymphoma as \"composite lymphoma\" or nodular lymphocyte prevalence histological subtype\n* Active HBV and HCV infection\n* HIV seropositivity\n* Pre-treatment with chemotherapy or radiation therapy\n* Malignant disease within the last 5 years (excluding basal skin tumors and carcinoma in situ of the cervix)\n* Women who are pregnant or breast feeding\n* Absence of FDG-avid lymphoma lesions on baseline PET scan\n* Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.",{"count":495,"type":20},518,[84],"The final analysis of GHSG HD11 study (not PET driven) showed that 30 Gy IFRT still remains the standard dose after 4 ABVD.\n\nEarly PET negativity might allow safe radiation de-escalation in patients achieving a metabolic complete response after 2 ABVD.\n\nThe aim of Priority trial is to explore whether radiotherapy could be safely deescalated to 20 Gy without loss of efficacy in patients treated with four cycles of ABVD who achieved complete metabolic response after the first two cycles.",[499],"Hodgkin Lymphoma",[501,502,503,504,505,506,507,508,509,510,511,512],"Hodgkin lymphoma","Early stage","unfavourable","untreated","ABVD","chemotherapy","radiotherapy","20 Gy","30 Gy","randomization","PET guided","involved site","2025-12-02",{"date":515,"type":36},"2025-12-09",{"date":517,"type":20},"2026-03-01",{"date":519,"type":20},"2033-03-01",{"name":42,"class":43},38,{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":16,"minAge":530,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":543},"100576135","study-on-plasmablastic-lymphoma-patients-100576135","NCT06781359","Study on Plasmablastic Lymphoma Patients","An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients","FIL_PlaLy","Inclusion Criteria:\n\n* Diagnosis of plasmablastic lymphoma (PBL) between Jan 1st 2000, and Dec 31st 2022\n* Histologically confirmed plasmablastic lymphoma (PBL) diagnosis according to local pathological report\n* Age \\> 18 years old\n* Availability of complete medical records\n* Availability of histopathological material requested by the study\n\nExclusion Criteria:\n\n* Any other histology than PBL\n* Lack of complete medical records\n* Lack of histopathological material requested by the study","15 Years",{"count":413,"type":20},"This is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and\u002For radio-metabolic) in patients affected by PBL.",[122],[535,128],"Plasmablastic lymphoma","2025-12-01",{"date":513,"type":36},{"date":539,"type":36},"2025-02-14",{"date":541,"type":20},"2028-02-01",{"name":42,"class":43},23,{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":554,"conditions":555,"keywords":559,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":139},"100561338","systemic-therapies-in-the-treatment-of-cutaneous-t-cell-lymphoma-100561338","NCT06588868","Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma","Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study","FIL_CTCL","Inclusion Criteria:\n\n* Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.\n* Age ≥18 years.\n* Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.\n* Availability of complete medical records in order to provide protocol required variables\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients not meeting the above-mentioned inclusion criteria.\n* Refuse to sign a written informed consent.",{"count":553,"type":20},400,"The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.",[556,557,558],"Cutaneous T Cell Lymphoma","Cutaneous T-Cell Lymphoma\u002FMycosis Fungoides","Cutaneous T-Cell Lymphoma\u002FSezary Syndrome",[556,560,561,562,563,564],"Mycosis Fungoides","Sézary Syndrome","Retrospective","Systemic therapy","Real world",{"date":513,"type":36},{"date":567,"type":36},"2025-02-27",{"date":569,"type":20},"2026-07",{"name":42,"class":43},{"id":572,"slug":573,"hasResults":11,"nctId":574,"briefTitle":575,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":590,"locationsCount":403},"100528131","sarcopenia-and-simplified-geriatric-assessment-in-lymphoma-patients-undergoing-car-t-cell-therapy-the-filsar-car-project-100528131","NCT06156774","SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project","Inclusion Criteria:\n\n* Adult patients (≥ 18 years old).\n* Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug\n* Availability of a 18F-FDG PET\u002FCT scan or a full dose CT scan (without contrast media) pre-treatment with CART\n* Written informed consent voluntarily provided\n\nExclusion Criteria:\n\n* Patients not fulfilling the eligibility criteria",{"count":578,"type":20},130,"This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.",[581],"Non-hodgkin Lymphoma,B Cell",[581,583,584],"CAR-T","Sarcopenia",{"date":586,"type":36},"2025-12-08",{"date":588,"type":36},"2024-04-18",{"date":569,"type":20},{"name":42,"class":43},{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":16,"minAge":599,"maxAge":4,"enrollmentInfo":600,"targetDuration":4,"studyType":21,"phases":601,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":620},"100514375","phase-2-efficacy-and-safety-of-frontline-tislelizumab-in-patients-with-de-novo-hodgkin-lymphoma-unsuitable-for-standard-frontline-chemotherapy-100514375","NCT05977673","Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy","Efficacy and Safety of Frontline Tislelizumab in Patients With de Novo Hodgkin Lymphoma Unsuitable for Standard Frontline Chemotherapy: a Phase II, Open-label Study","FIL_Tisle-HL","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of de novo classical Hodgkin Lymphoma (cHL). Note: Availability of either block or unstained slides plus stained slides used by the local pathologist to make diagnosis, and of all pathology reports is mandatory for the study to perform central pathology review for confirmation of cHL diagnosis and for biological biomarkers assessments. Central pathology confirmation is not required to start treatment;\n* Patients \\>= 65 years ineligible for frontline standard chemotherapy (mainly due to medical comorbidities);\n* Treatment naïve;\n* Measurable disease defined as presence of both fluorodeoxyglucose-avid nodal involvement and at least one nodal target lesion measurable in two diameters (and at least 1.5 cm in its major diameter); • Indication for systemic treatment, i.e., all stages except IA without a large tumor burden, as radiotherapy is regarded curative in those patients;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C= 2;\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\> 109\u002FL (without growth factor support within 7 days of ANC measurement), unless due to bone marrow involvement by lymphoma\n  * Platelet \\> 50 x 109\u002FL (without growth factor support or transfusion within 7 days of platelets measurement) , unless due to bone marrow involvement by lymphoma\n  * Hemoglobin \\> 8 g\u002FdL (prior transfusion is acceptable)\n  * Creatinine clearance ≥ 30 ml\u002Fmin (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24-hour urine collection)\n  * Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase, and alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase ≤ 3.0 × upper limit of normal (ULN)\n  * Serum total bilirubin \\\u003C 1.5 × ULN (or \\\u003C 3 x ULN in case of documented Gilbert's syndrome)\n* Life expectancy ≥ 6 months;\n* Men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 4 months after last tislelizumab dose. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control method, e.g. vasectomy, use of condoms or complete sexual abstinence, when this is in line with the preferred and usual lifestyle of the subject.The use of condoms by male patients is required unless the female partner is permanently sterile. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner) and withdrawal are not acceptable methods of contraception.\n* Subject voluntarily signs and dates an informed consent form approved by an National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures, indicating that they understand the purpose of and procedures required for the study and are willing to participate in it;\n* Subject must be able to adhere to the study visit schedule and other protocol requirements, and to return to enrolling institution for follow-up (during the active monitoring phase of the study).\n\nExclusion Criteria:\n\n* Nodular lymphocyte predominant HL;\n* Any previous treatment (including radiation therapy) for HL;\n* Any active autoimmune disease requiring systemic treatment (including disease-modifying agents, corticosteroids, immunosuppressants) in the past 2 years; Note: Patients with the following diseases are not excluded and may proceed to further screening: Type I diabetes under control; Hypothyroidism (provided it is managed with hormone replacement therapy only); Controlled celiac disease;\n* Has known history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, acute lung diseases or evidence of dyspnea at rest or pulse oximetry of \\\u003C 92% while breathing room air;\n* A history of previous exposure to anti-PD1, anti-PDL1 or anti-PDL2 or anti-CTLA-4 agents for any disease other than HL;\n* Use of systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications ≤14 days from registration; Note: Inhaled or topical steroids and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease;\n* Known infection with HIV, human T-cell lymphotropic virus-1, -2; • Serologic status reflecting active hepatitis B defined as presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) (mandatory testing). Patients with occult or prior HBV infection (respectively defined as patient with HBsAg-\u002FHBcAb+ and patients HBsAg+ with HBV DNA undetectable) are eligible, provided that they are willing to undergo prophylactic antiviral medication according to local standard of care. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination are eligible;\n* Presence of hepatitis C virus (HCV) antibody (mandatory HCV antibody serology testing). Patients with presence of HCV antibody are eligible only if PCR is negative for HCV RNA;\n* Hypersensitivity to tislelizumab or any of its excipients;\n* Active central nervous system (CNS) involvement or leptomeningeal metastases involvement;\n* Evidence of other clinically significant uncontrolled and\u002For active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens;\n* Major surgery within 4 weeks of the first dose of study drug;\n* Vaccination with a live vaccine within 4 weeks prior to the first dose of study drug;\n* Clinically significant cardiovascular disease including the following:\n\n  * Myocardial infarction within 6 months before screening;\n  * Unstable angina within 3 months before screening;\n  * New York Heart Association Classification III or IV congestive heart failure;\n  * History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes);\n  * QTcF \\> 480 msecs based on Fridericia's formula;\n  * History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;\n  * Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \\> 170 mm Hg and diastolic blood pressure \\> 105 mm Hg at screening;\n* Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent;\n* Any history of other active malignancies within 3 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent;\n* History of severe hypersensitivity reactions to other monoclonal antibodies;\n* Concurrent participation in another therapeutic clinical trial.","65 Years",{"count":118,"type":20},[23],"This is a multicenter, prospective, non-randomized, open-label, phase 2 clinical study to evaluate the efficacy and safety of tislelizumab in patients with de novo Hodgkin Lymphoma deemed ineligible to frontline chemotherapy.",[499],[89,605,606,607,608,609,610,611,612,613],"Hodgkin","Tislelizumab","PD1","Checkpoint","Inhibitor","De novo","Unsuitable","Chemotherapy","Immune",{"date":586,"type":36},{"date":616,"type":36},"2024-05-23",{"date":618,"type":20},"2029-11",{"name":42,"class":43},10,{"id":622,"slug":623,"hasResults":11,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":627,"eligibilityCriteria":628,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":21,"phases":630,"briefSummary":631,"conditions":632,"keywords":633,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":642,"leadSponsor":644,"locationsCount":327},"100608917","phase-2-pirtobrutinib-as-frontline-therapy-for-elderly-unfitfrail-patient-with-mantle-cell-lymphoma-100608917","NCT07207785","PirtobrUtinib as Frontline Therapy for Elderly Unfit\u002FFrail Patient With MAntle Cell Lymphoma","PirtobrUtinib as Frontline Therapy for Elderly Unfit\u002FFrail Patient With MAntle Cell Lymphoma: a Phase II Study of the Fondazione Italiana Linfomi (FIL)","FIL_PUMA","Inclusion Criteria:\n\n1. Histologically documented diagnosis of nodal and extranodal mantle cell lymphoma (MCL) as defined in the 2022 edition of the World Health Organization (WHO) classification\n2. Availability of biopsy material for central pathology revision and mutational analysis including TP53 (Tumor Protein p53) mutations\n3. Age ≥ 70 years\n4. Previously untreated MCL\n5. Active disease in need of treatment according to clinical practice (patients with leukemic with symptomatic leukemic non nodal disease may be included)\n6. Ineligible to standard full-dose induction therapy (i.e. BR, R-CHOP, VR-CAP, RBAC500)\n7. sGA assessment performed before starting treatment\n\n   FRAIL patients defined as follows:\n   * Age ≥ 80 years\n   * Activities of Daily Living (ADL) \\\u003C6 residual functions and\u002For\n   * Instrumental Activities of Daily Living (IADL) \\\u003C8 residual functions and\u002For\n   * Cumulative Illness Rating Scale (CIRS): ≥ 1 comorbidity of grade 3-4 or ≥ 5 comorbidities of grade 2\n\n   UNFIT patients defined as follows:\n   * Age ≥ 80 years:\n   * ADL 6 residual functions and\n   * IADL 8 residual functions and\n   * CIRS 0 comorbidities of grade 3-4 and \\\u003C5 comorbidities of grade 2\n\n   or\n   * Age \\\u003C 80 years:\n   * ADL \\\u003C 5 residual functions and\u002For\n   * IADL \\\u003C 6 residual functions and\u002For\n   * CIRS ≥ 1 comorbidity of grade 3-4 or \\>8 comorbidities of grade 2\n8. Ann Arbor Stage I - IV\n9. At least one bi-dimensionally measurable lesion defined as \\> 1.5 cm in its largest dimension on CT scan\n10. Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2\n11. Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows:\n\n    1. Hemoglobin ≥ 8 g\u002FdL (independent of transfusions within 7 days of screening assessment)\n    2. White blood cells (WBC) \\> 2500\u002Fmmc with polymorphonuclear (cells) PMN≥750\u002F mmc) (independent of growth factor support within 7 days of screening assessment)\n    3. Platelets count ≥ 50000\u002Fmmc (independent of transfusions within 7 days of screening assessment)\n12. Adequate renal function:\n\n    * Creatinine clearance ≥ 30 mL\u002Fmin or\n    * Serum creatinine ≤ 2.5 mg \u002FdL\n13. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x upper limit of normal (ULN)\n14. Adequate hepatic function:\n\n    * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≤ 3 x the ULN or ≤ 5 x ULN with documented liver involvement\n    * Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and\u002For due to Gilbert's Disease\n15. Ability and willingness to comply with the study protocol procedure\n16. Life expectancy \\> 6 months\n17. The patient is able to take oral medications\n18. The patient must give written informed consent\n19. Male subjects must use highly effective contraception during sexual contact with a pregnant female or a female of childbearing potential from the start of study treatment and continuing for at least 3 months after the last dose of pirtobrutinib\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria are not eligible to enroll:\n\n1. Candidate to watch and wait due to indolent presentation\n2. Leukemic non-nodal MCL that has stable asymptomatic disease should not be included in this study\n3. Histological diagnosis different from MCL or leukemic non-nodal MCL\n4. Fit patients according to sGA eligible to standard full dose therapy\n5. Candidate or eligible to full-dose Bendamustine+Rituximab (BR), Rituximab + Cyclophosphamide, Hydroxydaunorubicin (doxorubicin), Oncovin (vincristine) e Prednisone (R-CHOP), bortezomib, rituximab, cyclophosphamide, doxorubicin, prednisone (VR-CAP), Rituximab, Bendamustine, Cytarabine (RBAC500) or any other full dose intensive chemotherapy\n6. Suspect or clinical evidence of central nervous system (CNS) involvement by lymphoma\n7. Contraindication to the use Bruton Tyrosine Kinase Inhibitor (BTKi)\n8. HBsAg positivity; HBsAg-negative patients with anti-hepatitis B core antigen (HBc) antibody can be enrolled if Hepatitis B Virus (HBV)-DNA are negative and prophylactic antiviral treatment is provided\n9. HIV positivity\n10. Active herpes zoster infection; previously infected patients is accepted only with concomitant treatment with Valacyclovir\n11. Major surgery within 4 weeks prior to investigation treatment\n12. Any history of other malignancies unless in remission and with life expectancy \\> 2 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer\n13. Patients who experienced grade ≥ 3 arrhythmia.\n14. History of severe bleeding diathesis (major bleeding event) Note: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2 g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome)\n15. History of stroke or intracranial hemorrhage within 6 months of investigation treatment\n16. History of Chimeric Antigen Receptor T-cell therapy (CAR-T) within 60 days of investigation treatment or presence of any of the following, regardless of prior Stem Cell Transplantation (SCT) and\u002For CAR-T therapy timing:\n\n    1. active graft versus host disease (GVHD);\n    2. cytopenia from incomplete blood cell count recovery post-transplant;\n    3. need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy;\n    4. ongoing immunosuppressive therapy (\\> 20 mg prednisone or equivalent daily)\n17. Evidence of any severe active acute or chronic infection\n18. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, HCV-RNA is required. Only patients with HCV-RNA negative are accepted.\n19. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible\n20. Clinically significant active malabsorption syndrome or other conditions likely to affect gastrointestinal (GI) absorption of the study drug\n21. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required\n22. Active uncontrolled auto-immune cytopenia (e.g., AutoImmune Hemolytic Anemia \\[AIHA\\], Idiopathic Thrombocytopenic Purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts\n23. Significant cardiovascular disease defined as:\n\n    1. unstable angina or acute coronary syndrome within the past 2 months prior to study enrollment\n    2. history of myocardial infarction within 3 months prior to study enrollment or\n    3. documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to study enrollment\n    4. ≥ Grade 3 New York Heart Association (NYHA) functional classification system of heart failure\n    5. Uncontrolled or symptomatic arrhythmias\n24. Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33):\n\n    1. Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n    2. Correction for underlying bundle branch block (BBB) allowed. Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n25. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent\n26. Absence of caregivers in non-autonomous patients\n27. Need of anticoagulation with warfarin or another vitamin K antagonist\n28. Vaccination with live vaccine within 28 days prior to investigation treatment\n29. Have a known hypersensitivity to any of the excipients of Pirtobrutinib or to any intended study medications",{"count":230,"type":20},[23],"This is a prospective, multicenter, phase II study, in elderly patients affected by Mantle cell lymphoma (MCL) defined as unfit\u002Ffrail according to Simplified Geriatric Assessment (sGA) and previously untreated.\n\nPatients will receive a treatment with Pirtobrutinib monotherapy until tumor progression, unacceptable adverse event, or patient decision for interruption.",[26],[634,157,158,635,636,637],"mantle cell lymphoma","monotherapy","pirtobrutinib","Jaypirca","2025-09-26",{"date":640,"type":36},"2025-10-06",{"date":306,"type":20},{"date":643,"type":20},"2030-02-01",{"name":42,"class":43},{"id":646,"slug":647,"hasResults":11,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":653,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":655,"conditions":656,"keywords":657,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":668,"locationsCount":327},"100596530","long-term-assessment-of-chlormethine-gel-in-mycosis-fungoides-100596530","NCT07046663","Long-term Assessment of Chlormethine Gel in Mycosis Fungoides","Long-term Assessment of Chlormethine Gel in Mycosis Fungoides: A Multicenter Retrospective Cohort Study","FIL_CLOR-CTCL","Inclusion Criteria:\n\n* Patients age ≥ 18\n* Histologically confirmed diagnosis of MF based on WHO Classification of Tumours, Haematolymphoid Tumours, 5th edition\n* Patients who are capable of understanding and willing, and able to read and write in Italian\n* Patients who have signed informed consent form\n* Patients who started treatment with chlormethine gel, from September 1, 2019 to September 30, 2024.\n* Patients must have a minimum follow-up period of 6 months following the initiation of chlormethine treatment.\n* Availability of complete medical records in order to provide protocol required variables.\n\nExclusion Criteria:\n\n* Patients for whom retrospective data or information on the type of therapy, duration, and clinical outcomes are not available in the center's medical records.\n* Refuse to sign a written informed consent.\n* Patients not meeting the above-mentioned inclusion criteria",true,{"count":82,"type":20},"The study aims to provide comprehensive insights into the long-term therapeutic outcomes, potential adverse effects, and overall patient experience with chlormethine gel, thereby informing clinical practice and guiding future treatment strategies for mycosis fungoides.",[557],[658,659,660,661],"mycosis fungoides","cutaneous T-cell lymphoma","chlormethine gel","long term assessment","2025-07-01",{"date":664,"type":36},"2025-07-04",{"date":666,"type":20},"2025-09",{"date":374,"type":20},{"name":42,"class":43},{"id":670,"slug":671,"hasResults":11,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":11,"sex":16,"minAge":599,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":21,"phases":679,"briefSummary":680,"conditions":681,"keywords":684,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":108},"100396462","phase-3-prephase-treatment-with-prednisone---vitamin-d-supplementation-followed-by-immunochemotherapy-100396462","NCT04442412","Prephase Treatment With Prednisone +\u002F- Vitamin D Supplementation Followed by Immunochemotherapy","Prephase Treatment With Prednisone +\u002F- Vitamin D Supplementation Followed by Immunochemotherapy in Elderly Patients With Diffuse Large B-Cell Lymphoma (DLBCL) A Randomized, Open Label, Phase III Study by Fondazione Italiana Linfomi.","FIL_PREVID","Inclusion criteria\n\n1. Histologically documented diagnosis of Diffuse Large B-cell Lymphoma or Follicular grade IIIb lymphoma, as defined in the 2017 edition of the World Health Organization (WHO) classification.\n2. Age ≥ 65 years\n3. Comprehensive Geriatric Assessment performed at baseline, before start of any treatment.\n4. Eastern Cooperative Oncology Group performance status (PS) ≤3\n5. Eligibility for anthracycline containing regimen (R-CHOP or R-miniCHOP)\n6. No previous treatment for DLBCL or Follicular grade IIIb lymphoma\n7. Ann Arbor stage I-IV\n8. At least one site of measurable nodal disease at baseline ≥ 1.5 cm in the longest transverse diameter as determined by CT scan ; or one metabolic active site of disease at baseline FDG-PET scan\n9. Serum basic levels of Vitamin D \\[25 (OH) VitD\\] ≤ 40 ng \u002F ml;\n10. Adequate hematological counts defined as follows:\n\n    * Absolute Neutrophil count \\> 1.5 x 109\u002FL unless due to bone marrow involvement by lymphoma\n    * Platelet count ≥ 80.000\u002Fmm3 unless due to bone marrow involvement by lymphoma\n11. Adequate renal function defined as follows:\n\n    \\- Creatinine ≤ 2 mg\u002FdL, unless secondary to lymphoma\n12. Adequate hepatic function defined as follows:\n\n    \\- Bilirubin ≤ 2 mg\u002FdL unless secondary to lymphoma\n13. LVEF \\> 50% at bidimensionally echocardiogram\n14. Life expectancy ≥ 6 months\n15. Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee , prior to the initiation of any screening or study-specific procedures\n16. Subject must be able to adhere to the study visit schedule and other protocol requirements\n17. Men must agree to use one of the below reported acceptable method of contraception for the duration of the study and for 3 months after receiving the last dose of immunochemotherapy, and to not donate sperm while on study.\n\nExclusion criteria\n\n1. Histological diagnosis different from Diffuse large B-Cell Lymphoma or Follicular grade IIIb lymphoma, including diagnosis of HGBL, with rearrangement of MYC, BCL2 and\u002For BCL6 (double-hit)\n2. Use of VitD supplementation as standard of care at dose higher than 10,000 U\u002Fweek\n3. Suspect or clinical evidence of CNS involvement by lymphoma\n4. Contraindication to the use of rituximab\n5. Contraindication to the use of VitD supplementation (Hypercalcemia\u002FHyperphosphatemia)\n6. Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug\n7. Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent\n8. Any history of other active malignancies within 2 years prior to study entry, with the exception of adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin or limited stage surgically removed breast cancer or adequately treated with radiation therapy or limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy or previous malignancy confined and surgically resected with curative intent\n9. Evidence of other clinically significant uncontrolled condition including, but not limited to:\n\n   * Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   * Chronic hepatitis B virus or hepatitis C requiring treatment.",{"count":678,"type":20},430,[84],"This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1 to 1 ratio to Arm A (Standard arm) or Arm B (Experimental arm).\n\nAll patients of both arms will receive a prephase with oral prednisone before 6 cycles Q21 of immunochemotherapy with R-CHOP or R-miniCHOP at standard doses; patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.",[682,683],"Diffuse Large B-Cell Lymphoma","Elderly Patients",[685,686,687],"Vitamin D","prednisone +\u002F- Vitamin D supplementation","randomized, open label, phase III","2022-08-23",{"date":690,"type":36},"2022-08-26",{"date":692,"type":36},"2021-03-23",{"date":694,"type":20},"2030-09-01",{"name":42,"class":43},""]