[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-central-nervous-system-cns-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-central-nervous-system-cns-lymphoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100603513","phase-1-a-study-of-mb-cart191-cellular-therapy-for-people-with-central-nervous-system-lymphoma-cnsl-100603513",false,"NCT07137494","A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)","A Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed\u002FRefractory Primary and Secondary Central Nervous System Lymphoma (CNSL) Using On- Site Manufacturing With the CliniMACS Prodigy Device","Inclusion Criteria:\n\n* Men and women who are at least 18 years of age on the day of consenting to the study.\n* Histologically documented primary or secondary central nervous system lymphoma of DLBCL subtype\n* Relapsed\u002Frefractory primary or secondary CNSL patients. All relapsed\u002F\u002Frefractory patients need to have received at least one prior CNS-directed methotrexate-based therapy. There is no restriction on the number of recurrences.\n* For relapsed patients, parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) within 21 days of study consent.\n* For refractory patients, there must be residual disease after their last line of therapy.\n* For patients with leptomeningeal disease only, CSF cytology and\u002For flow cytometry must document CSF findings consistent with CSF involvement by lymphoma and\u002For imaging findings consistent with CSF disease within 21 days of study registration (at the discretion of the investigator).\n* Creatinine Clearance ≥ 40 ml\u002Fmin\u002Fm2, direct bilirubin ≤2.0 mg\u002F100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)\n* Adequate pulmonary function as assessed by ≥90% oxygen saturation on room air by pulse oximetry.\n* Must be able to tolerate both MRI and CT scans\n* Must be able to tolerate lumbar puncture and\u002For Ommaya taps\n* Must have been either off corticosteroids, or on a stable or decreasing dose of dexamethasone equivalent ≤ 2 mg daily for 7 days before apheresis and 72 hours prior to CAR T cell infusion o Use of corticosteroids to treat CAR T cell toxicities per MSKCC guidelines is permitted\n\nExclusion Criteria:\n\n* ECOG performance status \\>2\n\n  o Patients with ECOG status of 2 will be enrolled at the discretion of the PI\n* Active systemic lymphoma (i.e. involvement outside of the CNS)\n* If the most recent CSF or brain tissue sample demonstrates absence of CD19 expression\n* Size of any single CNS lymphoma lesion exceeds 3 cm in maximal diameter in eloquent brain structures.\n* Prior treatment of systemic lymphoma with CD19-targeted CAR T cells\n* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.\n* Impaired cardiac function (LVEF \\\u003C40%) as assessed by most recent ECHO in the last 1 year.\n* Patients with autoimmune disease requiring systemic T cell-suppressive therapy.\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment\n* Patients with ocular lymphoma in the absence of other CNS involvement\n* Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C, or 3 months since allogeneic hematopoietic stem cell transplantation, prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.\n* Patients with HIV\n* Patients with active hepatitis B or hepatitis C infection (as manifested by either detectable hepatitis B virus DNA by PCR, hepatitis virus C RNA by PCR, or positivity for hepatitis B surface or core antigen)\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion\n* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin\n* Patients exposed to immune checkpoint inhibitor within 8 weeks\n* Use of herbal supplements are not allowed on study\n* Any other issue which, in the opinion of the treating physician or PI, would make the patient ineligible for the study.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses of MB-CART19.1 to find the highest dose that causes few or mild side effects in participants.",[26,27],"Primary Central Nervous System (CNS) Lymphoma","Secondary Central Nervous System Lymphoma",[29,30,31],"MB-CART19.1 Cellular Therapy","Relapsed\u002FRefractory","CliniMACS Prodigy Device","RECRUITING","2026-06-04",{"date":35,"type":36},"2026-06-05","ACTUAL",{"date":38,"type":36},"2025-08-14",{"date":40,"type":20},"2028-08",{"name":42,"class":43},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100640426","phase-2-r-pmdt-regimen-in-newly-diagnosed-pcnsl-100640426","NCT07604987","R-PMDT Regimen in Newly Diagnosed PCNSL","A Prospective, Multicenter, Open-Label, Single-Arm, Phase 2 Study to Evaluate the Efficacy and Safety of Rituximab, Pirtobrutinib, High-Dose Methotrexate, Dexamethasone, and Thiotepa (R-PMDT) in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n* Newly diagnosed primary central nervous system diffuse large B-cell lymphoma\n* Adequate hematologic function: ANC ≥1.0×10⁹\u002FL, PLT ≥75×10⁹\u002FL\n* Adequate hepatic function: ALT\u002FAST ≤3×ULN; total bilirubin ≤1.5×ULN\n* Adequate renal function: serum creatinine ≤2×ULN or CrCl ≥40 mL\u002Fmin\n* LVEF ≥55% by echocardiography\n* Baseline oxygen saturation \\>92% on room air\n* Expected survival ≥3 months\n\nExclusion Criteria:\n\n* Prior anti-lymphoma therapy other than corticosteroids.\n* Uncontrolled significant cardiovascular or cerebrovascular disease.\n* Uncontrolled active systemic bacterial, fungal, or viral infection.\n* Active hepatitis B and\u002For active hepatitis C (HCV RNA positive). Patients with positive hepatitis B surface antigen and\u002For core antibody but HBV-DNA \\\u003C 1000 IU\u002FmL may be included and should receive concurrent oral antiviral prophylaxis against HBV reactivation.\n* Hypersensitivity to any study drug or its components.\n* Other active malignancy, except for adequately controlled non-melanoma skin cancer, in situ carcinoma, or malignancy that has been in complete remission for ≥5 years.\n* Pregnant or lactating women. Fertile patients unwilling to use effective contraception.\n* Other conditions deemed inappropriate by the investigator.",{"count":53,"type":20},33,[55],"PHASE2","A total of six cycles of the R-PMDT regimen (rituximab, pirtobrutinib, high-dose methotrexate, dexamethasone, and thiotepa) will be administered to patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The primary objective is to assess the overall response rate (ORR) of R-PMDT. Secondary objectives include evaluating the complete response rate, progression-free survival (PFS), overall survival (OS), and safety.",[26],[59,60],"R-PMDT","PCNSL","2026-05-17",{"date":63,"type":36},"2026-05-22",{"date":65,"type":20},"2026-05-20",{"date":67,"type":20},"2030-05-20",{"name":69,"class":43},"Zou Dehui",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":81,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100574156","ctdna-for-early-response-assessment-in-pcnsl-treated-with-1st-line-curative-intent-nlg-pcnsl-01-100574156","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","70 Years",{"count":80,"type":20},60,"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],[60,86],"ctDNA","2024-12-31",{"date":89,"type":36},"2025-01-01",{"date":89,"type":20},{"date":92,"type":20},"2038-12-31",{"name":94,"class":95},"Nordic Lymphoma Group","NETWORK",5]