[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":154},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,76,104,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100638555","real-life-experience-of-brentuximab-vedotin-plus-chp-as-first-line-treatment-of-cd30-peripheral-t-cell-lymphomas-in-spain-100638555",false,"NCT07624838","Real-life Experience of Brentuximab Vedotin Plus CHP as First-line Treatment of CD30+ Peripheral T-cell Lymphomas in Spain","Inclusion Criteria:\n\n* Diagnosis of CD30-positive peripheral T-cell lymphoma, including anaplastic large cell lymphoma (ALK-positive, ALK-negative, breast implant-associated), peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, or enteropathy-associated T-cell lymphoma.\n* Patients 18 years of age or older at the time of treatment with BV-CHP.\n* Patients treated with brentuximab vedotin plus CHP as first-line therapy between January 2019 and September 2024\n\nExclusion Criteria:\n\n* Patients who have received prior treatment for their lymphoma\n* Patients who have received the combination as part of a clinical trial.","ALL","18 Years",{"count":18,"type":19},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate how well brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (CHP) works and how safe it is when used as first-line treatment in adults with CD30-positive peripheral T-cell lymphoma in Spain during routine clinical care.\n\nThe main questions this study aims to answer are:\n\n* How long do participants live without their lymphoma getting worse after starting treatment?\n* How well does this treatment reduce or eliminate the lymphoma?\n* How long do participants live after receiving this treatment?\n* What side effects do participants experience, including nerve problems and low white blood cell counts?\n\nParticipants have already received brentuximab vedotin plus CHP as part of their usual medical care. Researchers will collect information from existing medical records to better understand treatment outcomes and safety in real-world clinical practice across multiple centers in Spain.",[23],"CD30-Positive Peripheral T-Cell Lymphoma",[25,26,27,28,29,30],"Peripheral T-Cell Lymphoma","CD30","Brentuximab Vedotin","BV-CHP","Real-World Evidence","Observational Study","RECRUITING","2026-05-29",{"date":34,"type":35},"2026-06-03","ACTUAL",{"date":37,"type":35},"2026-02-15",{"date":39,"type":19},"2027-05",{"name":41,"class":42},"Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea","OTHER",37,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100614899","phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-pirtobrutinib-with-rituximab-in-patients-with-mantle-cell-lymphoma-100614899","NCT07285590","Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma","International Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Pirtobrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of Mantle Cell Lymphoma","IMCL-2023","Inclusion Criteria:\n\n1. Adult patients (≥18 years of age).\n2. Written informed consent must be obtained before any study-specific assessment is performed.\n3. Subjects with confirmed diagnosis of Mantle Cell Lymphoma according to the International Consensus Classification, (ICC) 2022\\] or World Health Organization (WHO) Classification 2022. Classical, small-cell variants and marginal-zone variants can be included.\n4. Naïve patients for MCL management (no prior therapies, excluding diagnostic splenectomy)\n5. Asymptomatic patients\n6. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2 (0-1)\n7. Clinical stage I-IV according to the Ann Arbor classification with no symptoms attributable to MCL\n8. Patients with a leukemic non-nodal presentation with mainly bone marrow or peripheral blood involvement are eligible. Other asymptomatic clinical presentations are acceptable in case of low tumour burden, including MCL with lymph node enlargement ≤ 3 cm in the largest diameter and with low proliferation index (Ki67 \\\u003C 30%)\n9. The following laboratory values at screening:\n\n   * Neutrophil count ≥ 1×109\u002FL, Haemoglobin level ≥ 100 g\u002FL and platelet count ≥100×109\u002FL\n   * Transaminases (AST and ALT) ≤ 3 x ULN\n   * Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's disease\n   * Calculated creatinine clearance ≥ 30 ml\u002Fmin according to Cockcroft\u002FGault Formula (140 - age) × body weight (kg) × 0.85 (if female)\u002F serum creatinine (mg\u002FdL) × 72\n   * 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 ULN.\n10. Stable disease without evidence of clinical progression for at least 3 months. Patients in prolonged observation may be included (over 3 months).\n11. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use highly effective contraception from the start of study treatment (See Appendix 4), during the treatment period and for at least 1 month following the last dose of pirtobrutinib and for 12 months following treatment with Rituximab.\n12. Male patients must use highly effective contraception (if sexually active with a female of child-bearing potential) according to the recommendations provided by the Clinical Trial Facilitation and Coordination Group (CTFG), from start of study treatment, during the treatment period, and for at least 1 month following the last dose of pirtobrutinib and for 12 months following treatment with rituximab.\n13. Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n14. Not included in other clinical trial or treated with an experimental drug unrelated to MCL within the past 2 years\n\nExclusion Criteria:\n\n1. Subjects with aggressive histological variants: blastoid and pleomorphic variants of MCL\n2. B-cell monoclonal lymphocytosis with MCL phenotype\n3. Presence of B symptoms or any relevant symptoms related to the MCL.\n4. Nodal clinical forms with lymph node enlargement \\> 3 cm (largest diameter).\n5. Organ dysfunction related to MCL including creatinine level \\> 2 mg\u002Fdl or altered liver biochemistry (\\> 3x ULN).\n6. Serum LDH over ULN\n7. Known central nervous system (CNS) infiltration.\n8. Expected MCL therapy requirement in a short time (\\\u003C 3 months)\n9. Anticoagulation requirement with vitamin K antagonists\n10. History of bleeding diathesis\n11. Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion.\n12. Significant cardiovascular disease defined as: i) unstable angina or acute coronary syndrome within the past 2 months prior to randomization; ii) history of myocardial infarction within 3 months prior to randomization or documented LVEF by any method of ≤ 40% in the 12 months prior to inclusion; iii) ≥ Grade 3 NYHA functional classification system of heart failure; iv) Uncontrolled or symptomatic arrhythmias.\n13. 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). 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. Correction for underlying bundle branch block (BBB) allowed.\n\n    NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n14. Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrolment.\n15. Known active hepatitis B virus (HBV) infection based on criteria below: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before inclusion. Patients who are HBV DNA PCR positive will be excluded. Prophylactic antiviral treatment will be required in the patients with positive anti-HBc finally eligible.\n16. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before inclusion. Patients who are hepatitis C RNA positive will be excluded.\n17. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.\n18. Concomitant or previous malignancies the last 2 years other than basal skin cancer or in situ uterine cervix cancer.\n19. Major surgery within 4 weeks of inclusion.\n20. Vaccinated with live, attenuated vaccines within 4 weeks of inclusion.\n21. Active uncontrolled auto-immune cytopenia (e.g., autoimmune haemolytic anaemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrolment to maintain adequate blood counts.\n22. 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 any other clinically significant active disease process which in the opinion of the investigator may pose a risk for patient participation (screening for chronic conditions is not required).\n23. Known hypersensitivity to any of the excipients of Pirtobrutinib or Rituximab or any intended study medications.\n24. Females who are pregnant or breastfeeding or plan to become pregnant or initiate breastfeeding during the study or within 1 month of the last dose of pirtobrutinib or 12 months of the last dose of rituximab.\n25. Patients unable to take oral medication or with clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.",{"count":53,"type":19},50,"INTERVENTIONAL",[56],"PHASE2","This is a multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.",[59],"Mantle Cell Lymphoma (MCL)",[61,62,63,64,65,66],"lymphoma","Geltamo","Rituximab","Pirtobrutinib","Mantle cell lymphoma","MCL","2025-12-02",{"date":69,"type":35},"2025-12-16",{"date":71,"type":35},"2025-09-30",{"date":73,"type":19},"2032-12",{"name":41,"class":42},16,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":54,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100612528","phase-2-study-to-evaluate-the-efficacy-of-axicabtagene-ciloleucel-in-patients-with-late-relapse-of-diffuse-large-b-cell-lymphoma-100612528","NCT07254754","Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma","LATE-R Trial. A Phase II, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy of Axicabtagene Ciloleucel in Patients With Late Relapse of Diffuse Large B-Cell Lymphoma","LATE-R-GEL-23","Inclusion Criteria:\n\n1. Signed written Informed Consent Form\n2. Age \\> 18 years\n3. Patient who understands and speaks one of the country official languages\n4. Histologically proven relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL) of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL) and follicular lymphoma Grade 3B per WHO 2016 classification. Indolent B-NHL who transformed into aggressive B-NHL and were previously treated with R-CHOP-like after transformation are eligible. Primary mediastinal B-cell lymphoma are not eligible.\n5. Positron-emission tomography (PET)-positive disease\n6. Patients must have received adequate first-line therapy including at a minimum:\n\n   * An anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and\n   * CHOP or CHOP-like chemotherapy Note: CHOP-like chemotherapy corresponds to ACVBP, EPOCH, or COPADEM. Dose-reduced CHOP (i.e., miniCHOP) is excluded except for dose-reductions of vincristine due to peripheral neuropathy. Patients who have received additional drugs in combination with CHOP or CHOP-like regimen are eligible.\n7. Relapsed disease after first line chemo immunotherapy (full dose of R-CHOP or R-CHOP-like regimen), documented by PET-scan and biopsy:\n\n   • Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse after 12 months and up to 5 years from end of first-line therapy.\n8. Patients must meet CAR-T-eligible criteria as defined by:\n\n   * Patient deemed eligible for CAR T-cells therapy by the CAR-T physician\n   * AND all the following criteria:\n\n     * ECOG performance status of 0, 1 or 2\n     * Adequate vascular access for leukapheresis procedure (either peripheral or central venous line)\n     * Absolute neutrophil count (ANC) ≥ 1 x 109\u002FL\n     * Platelets ≥ 75 x 109\u002FL\n     * Absolute lymphocyte count ≥ 0.1 x 109\u002FL\n     * Creatinine clearance (CrCl) as estimated by Cockcroft Gault or MDRD ≥ 40 mL\u002Fmin\n     * Serum alanine aminotransferase\u002Faspartate aminotransferase (ALT\u002FAST) ≤ 2.5xULN\n     * Total bilirubin \\\u003C1.5 mg\u002FdL, except in patients with Gilbert's syndrome\n     * Cardiac ejection fraction ≥ 45%\n     * Baseline oxygen saturation ≥ 92% on room air\n9. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential).\n\nExclusion Criteria:\n\n1. Patients who received more than one prior line of systemic therapy\n2. Early relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapse before 12 months from end of first-line therapy.\n3. Refractory disease defined as:\n\n   * Progressive disease (PD) during first-line therapy\n   * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP)\n   * Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease\n4. Patients who received first line of R-CHOP or obinutuzumab-CHOP for an indolent B-NHL who relapse as transformed aggressive B-NHL after a year from the end of first-line therapy are NOT eligible.\n5. Prior CD19 targeted therapy\n6. Patients with cardiac atrial or cardiac ventricular lymphoma involvement\n7. Requirement for urgent therapy due to tumor mass effects, such as bowel obstruction or blood vessel compression\n8. Patient with clinically significant pleural effusion\n9. History of another primary malignancy that has not been in remission for at least 3 years (except for nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast)). A maintenance treatment is not allowed.\n10. Patients with detectable Central Nervous System (CNS) lymphoma. Patients with a history of CNS lymphoma but no active CNS disease (after systematic MRI and lumbar puncture) at the time of enrolment will be eligible.\n11. Presence of CNS disorder such as dementia, autoimmune disease with CNS involvement, cerebral edema with confirmed structural defects by appropriate imaging, or seizure disorders requiring active anticonvulsive medication. History of stroke, transient ischemic attack, or posterior reversible encephalopathy syndrome (PRES) within 12 months prior to enrolment.\n12. Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural\u002Fperitoneal\u002Fpericardial catheter). Ommaya reservoirs and dedicated central venous access catheters, such as a Port-a-Cath or Hickman catheter, are permitted.\n13. History of acute or chronic active hepatitis B or C infection (seropositivity). If there is a positive history of treated hepatitis B or hepatitis C (negative HBsAg and positive Anti-HBc\u002F positive anti-HCV), the viral load HBV DNA\u002F HCV RNA) must be undetectable per quantitative polymerase chain reaction (PCR) and\u002For nucleic acid testing\n14. Positive for human immunodeficiency virus (HIV) unless taking appropriate anti-HIV medications, with an undetectable viral load by PCR and with a CD4 count \\> 200 cells\u002FuL.\n15. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antimicrobials or other treatment at the time of leukapheresis or axicabtagene ciloleucel administration\n16. History of any one of the following cardiovascular conditions within the past 12 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease\n17. Presence of primary immunodeficiency\n18. History of any medical condition including but not limited to autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression and\u002For systemic disease modifying agents within the last year. Endocrine conditions that require maintenance with physiologic dose steroids are allowed.\n19. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed.\n20. History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study\n21. History of severe, immediate hypersensitivity reaction attributed to aminoglycosides, cyclophosphamide or fludarabine\n22. Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment or anticipation of need for such a vaccine during the study\n23. Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of lymphodepletion chemotherapy on the fetus or infant.\n24. Patients of either sex who are not willing to practice birth control from the time of consent during treatment and for at least 12 months after conditioning chemotherapy dosing or axicabtagene ciloleucel dosing, whichever is later\n25. In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation\n26. Adult person unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.",{"count":85,"type":19},45,[56],"Single-arm, open-label, multicenter, phase II trial aiming to include approximately 45 patients over 24 months. Patients will receive axicabtagene ciloleucel infusion and will be followed up to 5 years.\n\nThe total duration of the study is therefore of 7 years.",[89],"DIFFUSE LARGE B-CELL LYMPHOMA",[61,91,92,89,93,94],"axicabtagene","geltamo","DLBCL","RELAPSE","2025-11-20",{"date":97,"type":35},"2025-11-28",{"date":99,"type":35},"2024-11-20",{"date":101,"type":19},"2031-12-31",{"name":41,"class":42},15,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":54,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":103},"100602647","phase-2-response-adaptive-to-epcoritamab-in-first-relapse-study-to-evaluate-the-efficacy-of-eptoritamab-in-patients-with-relapserefractory-large-b-cell-lymphoma-100602647","NCT07126236","Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse\u002FRefractory Large B Cell Lymphoma","Response-adaptive to Epcoritamab In First Relapse: A Phase II, Response-adaptive, Open-Label, Multicenter Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse\u002FRefractory Large B Cell Lymphoma","REPIFIR","Inclusion Criteria:\n\n1. Written informed consent must be obtained before any study-specific assessment is performed.\n2. Age \\>18 years\n3. Patients with Relapse\u002FRefractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL), High-grade B-cell lymphoma (HGBCL); and grade 3B Follicular Lymphoma.\n\n   Relapsed disease is defined as complete remission to first line therapy followed by a recurrence of the disease after a minimum of 6 months of completion of first-line therapy. A biopsy at the time of relapse is recommended but not mandatory.\n\n   Refractory disease is defined as no objective response to first line therapy (biopsy not mandatory if diagnostic sample available). Four groups of patients are eligible:\n   * PD as best response to first line therapy.\n   * SD as best response after at least 4 cycles of first line therapy.\n   * PR as best response after at least 6 cycles of first line therapy.\n   * CR and disease recurrence within \\\u003C 6 months from the completion of first-line therapy.\n4. Patients must have received adequate first-line therapy including at a minimum: an anti-CD20 monoclonal antibody (rituximab or obinutuzumab), and CHOP (cyclophosphamide, hydroxydaunomycin, oncovin, and prednisone) or CHOP-like chemotherapy.\n5. At the investigator's discretion, the patient should not be a candidate for 1st relapse CAR-T therapy or unwilling to receive CAR-T therapy.\n6. Patients must be autologous stem cell transplantation (ASCT)-ineligible: Age ≥65 and\u002For HTC-CI ≥3 or or unwilling to receive transplant.\n7. PET positive disease.\n8. Performance status according to Eastern Cooperative Oncology Group (ECOG) 0 to 2.\n9. Patients meeting with the following hematology values:\n\n   * Hemoglobin ≥8 g\u002Fdl (transfusion support permitted but not within 7 days of screening lab collection)\n   * Absolute neutrophil count (ANC) ≥ 1\u002F109\u002FL (growth factor support allowed in case of bone marrow involvement).\n   * Absolute lymphocyte count ≥ 0.1\u002F109\u002FL,\n   * Platelet count ≥ 70\u002F109\u002FL (unless secondary to bone marrow involvement, OR ≥50x\u002F109\u002FL if documented bone marrow involvement). Platelet transfusions permitted but not within 7 days of screening lab collection.\n10. Female patients of child-bearing potential must have a negative urine or serum pregnancy test at screening and agree to use highly effective methods of contraception (e.g., established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS) upon enrollment according to the recommendations provided by Clinical Trial Facilitation Group (CTFG), during the treatment period and for 4 months after the last dose of study medication. Moreover, the patient must agree to ongoing pregnancy testing during the course of the study, and after study therapy has ended. This applies even if the patient practices complete and continued sexual abstinence.\n\n    Women not of childbearing potential are defined as: premenarchal; postmenopausal (greater than 50 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level greater than 40 IU per L or milli-International unit (mIU) per mL); permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy.\n11. Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment according to the recommendations provided by CTFG, during the treatment period, and for 4 months following the last dose of investigational drug or agreement to remain abstinent. Agreement to refrain from donating blood or sperm during the study participation and for 4 months after the last dose of study medication.\n12. Women must agree not to donate blood or oocytes during the course of the study and for 4 months after the last dose of study medication. Restrictions concerning blood donation apply as well to females who are not of childbearing potential. Men must also not donate sperm during the trial and for 4 months after receiving the last dose of study drug.\n13. Females of childbearing potential must refrain from breastfeeding during the course of the study and for 4 months after the last dose of study medication.\n14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n15. Not included in other clinical trial or treated with an experimental drug.\n\nExclusion Criteria:\n\n1. Patients who received more than one prior line of systemic therapy\n2. Patients with detectable Central Nervous System (CNS) lymphoma\n3. Significant organ function impairment:\n\n   * creatinine clearance calculated by Cockcroft-Gault ≤ 45 ml\u002Fmin\n   * direct bilirubin level \\\u003C 2 x ULN (except in patients with Gilbert's syndrome),\n   * alanine transaminase (ALT) and aspartate aminotransferase (AST) \\>3 × ULN or \\>5 × ULN in cases of documented liver involvement.\n   * clinically relevant pleural effusion,\n   * left ventricular ejection fraction (LVEF) ≤ 45%\n4. Serious accompanying disorder leading to impaired organ function causing significant clinical problems and reduced life expectancy of less than 3 months.\n5. Have a history of deep venous thrombosis\u002Fembolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing\u002Fable to take venous thromboembolic event prophylaxis during the entire treatment period\n6. Known clinically significant cardiac disease, including:\n\n   * Onset of unstable angina pectoris within 6 months of signing the patient informed consent form.\n   * Acute myocardial infarction within 6 months of signing the patient informed consent form.\n   * Congestive heart failure (grade III or IV as classified by the New York Heart Association.\n   * Left ventricular ejection fraction ≤45%.\n7. Known past or current malignancy other than inclusion diagnosis, except for: Cervical carcinoma of Stage 1B or less; Non-invasive basal cell or squamous cell skin carcinoma; Non-invasive, superficial bladder cancer; Localized low grade prostate cancer (up to Gleason score 6); DCIS of the breast; Other malignancy that has been treated with curative intent and has remained in remission for 3 years.\n8. Previous ASCT.\n9. Prior anti-CD3 and CD20 bispecific antibodies therapy or prior treatment with tafasitamab.\n10. Presence of severe infection that is uncontrolled or requiring IV antimicrobials for management.\n11. History of HIV infection or acute or chronic active hepatitis B or C infection.\n\n    * Individuals with positive HIV serology may be included if negative viral load and CD4 \\>200\u002Fmm3. For being included, patients should have controlled disease and been on treatment for at least 1 year\n    * Individuals with history of hepatitis infection with positive antibodies (anti-HB and anti-HV) might be included if negative viral load (negative hepatitis B PCR). Patients who are HBcAb positive must receive HBV prophylaxis while on treatment. Patients with positive HbsAg are excluded. Patients who are hepatitis B PCR positive will be excluded. Patients who are hepatitis C RNA positive will be excluded.\n12. Females who are pregnant or breastfeeding.\n13. Richter's transformation or prior chronic lymphocytic leukemia (CLL).\n14. Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 4 weeks prior to Cycle 1 Day 1.\n15. Recent major surgery (within 4 weeks before the start of Cycle 1 Day 1) other than for diagnosis.\n16. Vaccination with a live vaccine or COVID-19 vaccination within 4 weeks prior to treatment.\n17. History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure. History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.\n18. Close affiliation with the investigator (e.g. a close relative) or persons working at the study site.",{"count":113,"type":19},80,[56],"phase II, response-adaptive, open-label, multicenter study aiming to include 80 patients in 78 months. Patients will receive 3 cycles of epcoritamab monotherapy and, since cycle 4, they can continue with epcoritamab monotherapy until cycle 12 or change to combination therapy (epcoritamab + tafasitamab + lenalidomide) until cycle 15. Patients will be followed up to 5 years.",[117],"Large B Cell Lymphoma",[61,92,89,93,94,119,120,121],"epcoritamab","tafasitamab","lenalidomide","2025-08-09",{"date":124,"type":35},"2025-08-17",{"date":126,"type":35},"2025-08-04",{"date":128,"type":19},"2031-12",{"name":41,"class":42},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":54,"phases":141,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100391566","phase-2-brentuximab-vedotin-in-second-line-therapy-before-transplant-100391566","NCT04378647","BREntuximab Vedotin in SEcond LIne Therapy BEfore Transplant","A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy With Brentuximab Vedotin-ESHAP vs ESHAP in Patients With Relapsed \u002F Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (Instead of Autologous Hematopoietic Stem Cell Transplantation) in Those Who Attained a Metabolic Complete Remission After Salvage Therapy","BRESELIBET","Inclusion Criteria:\n\nPatients with classical HL CD30+ confirmed histologically (either at the time of diagnosis \u002F at the time of first relapse) will be included in the trial\n\n* Male or female patients 18 to 65 years of age\n* Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care\n* Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse\n* Male patients, even if surgically sterilized, (i.e., status post-vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse\n* ECOG 0 to 2\n* Measurable disease at time of enrolment (lymphadenopathy\u002F extranodal mass of at least 1.5 cm)\n* No evidence of neuropathy grade ≥2\n* Clinical laboratory values as specified in the protocol below within 7 days before the first dose of study drug\n\nExclusion Criteria:\n\n* Lymphocyte predominant nodular Hodgkin's lymphoma\n* Prior treatment with brentuximab vedotin\n* Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug\n* Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol.\n* Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML)\n* Symptomatic neurologic disease compromising normal activities of daily living or requiring medic\n* Any sensory or motor peripheral neuropathy greater than or equal to Grade 2\n* Known history of any of the following cardiovascular conditions defined in the protocol\n* Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose\n* Patients that have not completed any prior treatment chemotherapy and\u002For other investigational agents within at least 5 half-lives (or 28 days if the half-lives are unknown) of last dose of that prior treatment\n* Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.\n* Known human immunodeficiency virus (HIV) positive\n* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection\n* Focal radiation therapy within 30 days prior to study recruitment\n* Major surgery within 28 days prior to randomization\n* Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease.\n* Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.","65 Years",{"count":140,"type":19},150,[56],"A Randomized Phase IIb Study, Evaluating Efficacy of Salvage Therapy with Brentuximab Vedotin-ESHAP vs ESHAP in Patients with Relapsed \u002F Refractory Classical Hodgkin's Lymphoma, Followed by Brentuximab Vedotin Consolidation (instead of Autologous Hematopoietic Stem Cell Transplantation) in Those who Attained a Metabolic Complete Remission after Salvage Therapy",[144],"Hodgkin Lymphoma, Adult","2024-02-23",{"date":147,"type":35},"2024-02-26",{"date":149,"type":35},"2020-06-01",{"date":151,"type":19},"2026-08-30",{"name":41,"class":42},19,""]