[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nordic Lymphoma Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100574156","ctdna-for-early-response-assessment-in-pcnsl-treated-with-1st-line-curative-intent-nlg-pcnsl-01-100574156",false,"NCT06755619","CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)","CAPCI","Inclusion Criteria:\n\n* Age 18-70 years at diagnosis\n* Histologically or cytologically verified diffuse large B-cell lymphoma (DLBCL) of the central nervous system (CNS)\n* No prior treatment for PCNSL (pre-treatment corticosteroids are allowed and recommended)\n* Fit for standard of care (SOC) 1st line therapy with a curative intent such as full-dose MATRix, according to local policy\n* Able to give voluntary written informed consent\n* If the patient is temporarily incapacitated to give the voluntary written informed consent, due to PCNSL, the informed consent can be obtained from a legally acceptable representative, according to the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Guideline for Good Clinical Practice (ICH-GCP) guidelines\n\nExclusion Criteria:\n\n* Lymphoma outside the CNS\n* History of prior hematological malignancy e.g. low grade B-cell lymphoma\n* Psychiatric illness or condition, other than PCNSL, which could interfere with the ability to understand the requirements of the study","ALL","18 Years","70 Years",{"count":20,"type":21},60,"ESTIMATED","10 Years","OBSERVATIONAL","This is an international, prospective, multicenter trial with the aim of characterizing circulating tumor DNA (ctDNA) for early response assessment in PCNSL patients treated with standard of care (SOC) 1st line therapy with a curative intent (Figure 1). Secondary endpoints are to assess the clinical characteristics, health-related quality of life (HRQoL), neurological status, and outcome of newly diagnosed primary central nervous system lymphoma (PCNSL) patients in the Nordic countries. Patients eligible for a curative intent SOC 1st line therapy, such as MATRix + high-dose chemotherapy and autologous stem cell transplantation (HDCT\u002FASCT), are eligible for the trial. Diagnostic tumor tissue, cerebrospinal fluid (CSF), and plasma samples are collected for ctDNA and translational analyses with the aim describing new prognostic and predictive biomarkers. Treatment responses are assessed with the International PCNSL Collaborative Group (IPCG) response criteria, and diagnostic and response assessment magnetic resonance imaging (MRI) images are centrally analyzed in order to describe new prognostic and predictive markers.",[26],"Primary Central Nervous System (CNS) Lymphoma",[28,29],"PCNSL","ctDNA","RECRUITING","2024-12-31",{"date":33,"type":34},"2025-01-01","ACTUAL",{"date":33,"type":21},{"date":37,"type":21},"2038-12-31",{"name":39,"class":40},"Nordic Lymphoma Group","NETWORK",5,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100388057","phase-3-a-randomized-multicenter-phase-iii-trial-comparing-treatment-with-r-mini-chop-with-r-mini-chp--polatuzumab-vedotin-in-patients-with-diffuse-large-cell-b-cell-lymphoma-100388057","NCT04332822","A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma","R-MINI-CHOP Versus R-MINI-CHP in Combination With Polatuzumab-vedotin, as Primary Treatment for Patients With Diffuse Large B-cell Lymphoma, ≥80 Years, or Frail ≥75 Years - an Open Label Randomized Nordic Lymphoma Group Phase III Trial","POLAR BEAR","Inclusion Criteria:\n\n* Age ≥80 years or frail ≥75 years, according to simplified comprehensive geriatric assessment\n* Histologically confirmed lymphoma belonging to one of the following subtypes:\n\n  1. diffuse large B-cell lymphoma, including transformation from an indolent lymphoma\n  2. follicular lymphoma grade 3B\n  3. T-cell\u002Fhistiocyte-rich LBCL\n  4. primary cutaneous DLBCL, leg type\n  5. EBV-positive DLBCL, NOS\n  6. primary mediastinal LBCL\n  7. high grade B-cell lymphoma with MYC\u002FBCL2 rearrangement\n* Stage II-IV disease\n* At least 1 measurable site of disease (\\>1.5 cm long axis)\n* No previous treatment for lymphoma\n* WHO performance status 0 - 3 (Grade 3 if related to DLBCL)\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe cardiac disease: NYHA grade 3-4\n* CNS involvement at diagnosis\n* Uncontrolled serious infection\n* Impaired liver (transaminases \\> 3x normal upper limit or bilirubin \\> 1.5 x normal upper limit, unless due to Gilbert´s syndrome) , renal (GFR\\\u003C30ml\u002Fmin) or other organ function not caused by lymphoma, which will interfere with the treatment.\n* Absolute neutrophil count (ANC) \\\u003C1000 cells\u002FµL or platelets \\\u003C100,000 cells\u002FµL, unless due to lymphoma\n* Any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma, unless treated with curative intent, and without relapse since 2 years, or low grade prostate cancer, not in need of treatment\n* Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study\n* Known hypersensitivity to rituximab, polatuzumab vedotin, cyclophosphamide, vincristine or doxorubicin, or HACA against rituximab\n* Peripheral neuropathy grade ≥ 2","75 Years",{"count":52,"type":21},300,"INTERVENTIONAL",[55],"PHASE3","This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.",[58,59],"DLBCL","Diffuse Large B Cell Lymphoma",[58,59],"2024-09-10",{"date":63,"type":34},"2024-09-19",{"date":65,"type":34},"2020-08-19",{"date":67,"type":21},"2028-12-28",{"name":39,"class":40},69,""]