[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-cns-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-cns-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,69,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100410687","phase-2-study-of-lenalidomiderituximab-maintenance-for-transplantation-ineligible-patients-with-pcnsl-100410687",false,"NCT04627753","Study of Lenalidomide\u002FRituximab Maintenance for Transplantation Ineligible Patients With PCNSL.","Phase II Study of Lenalidomide\u002FRituximab Maintenance for Transplantation Ineligible Patients With Primary CNS Diffuse Large B-cell Lymphoma (Nickname: Lemon-C Study)","Lemon-C","Inclusion Criteria:\n\n1. Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for induction of remission of primary central nervous system lymphoma have reached a complete or partial response.\n2. Those who are unable to transplant autologous hematopoietic stem cells for the following reasons\n\n   * If you are 65 years of age or older or if you are judged to have a weak systemic condition before receiving high-dose chemotherapy\n   * Refusal of autologous hematopoietic stem cell transplantation after high-dose chemotherapy\n3. Adequate laboratory functional values\n\n   * Absolute neutrophil count ≥ 1000\u002Ful\n   * Platelet count ≥ 50,000\u002Ful\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Serum calcium ≤ 12.0mg\u002FdL\n   * Serum creatinine ≤ 1.5 X UNL\n   * AST\u002FALT ≤ 2.5 X UNL\n   * Total bilirubin ≤ 1.5 X UNL\n4. Hepatitis B patients with combination of prophylactic antiviral therapy\n5. ECOG PS 0-2\n6. Those who can take oral medication\n7. Written informed consent under institutional guidelines.\n8. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU\u002FmL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide.\n9. Effective method of contraception should be used during and for 28 days following the last dose of the drug\n\n   \\- FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n10. Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP.\n\nExclusion Criteria:\n\n1. If autotransplantation is planned after chemotherapy\n2. Active congestive heart failure (New York Heart Association \\[NYHA\\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle.\n3. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents.\n4. Uncontrolled hepatitis C infection and\u002For hepatitis B (except for patients with hepatitis B surface antigen \\[SAg\\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).\n5. . Known human immunodeficiency (HIV) seropositive\n6. Those who are unable to take oral medication\n7. Patients with a history of malignant tumors other than the target diseases except for the following cases\n\n   * If the tumor has not been treated for at least 5 years or is disease-free\n   * Patients at least 1 year after complete resection of basal cell carcinoma \u002F squamous cell carcinoma or successful treatment of cervical epithelial cancer\n8. Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria\n9. Occurrence of blood clots or embolism within 6 months before starting screening\n10. Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.)\n11. Patients with seizure disorder requiring medication\n12. Female patients who are pregnant or lactating.\n13. Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.\n14. Patients with hyperreactivity to rituximab.","ALL","19 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment.\n* The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration\n* Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone.\n* However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half.\n* Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).",[27],"Primary CNS Lymphoma","RECRUITING","2026-04-22",{"date":31,"type":32},"2026-04-23","ACTUAL",{"date":34,"type":32},"2020-11-02",{"date":36,"type":21},"2028-11-02",{"name":38,"class":39},"Kim, Seok Jin","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":40},"100442067","diagnosis-objective-response-therapy-100442067","NCT05036564","Diagnosis; Objective RespOnse; THErApy","Mutational Analysis in the Cerebrospinal Fluid to Improve Diagnostic Sensitivity, Response Definition and Precision Treatment in Primary Central Nervous System Lymphoma","DOROTHEA","Inclusion Criteria for study population:\n\n1. Age ≥18 years\n2. Newly diagnosed PCNSL with available clinical and radiological data, CSF and histopathological brain biopsy material fresh and\u002For formalin fixed and paraffin embedded;\n3. No contraindications to stereotactic or open brain biopsy and lumbar puncture;\n4. No formal contraindications to intravenous chemo-immunotherapy or whole-brain irradiation;\n5. Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without any prejudice.\n\nExclusion Criteria for study population:\n\n1. Patients with concomitant CNS and systemic involvement at presentation (potentially eligible as \"control\"; see below)\n2. Patients with CNS lymphoma other than DLBCL subtype\n3. Any other serious medical condition which could impair the ability of the patient to participate in the trial\n4. Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation.\n5. Previous or concurrent malignancies at other sites diagnosed or relapsed within the last 3 years before PCNSL diagnosis. Patients with surgically cured in situ carcinomas and basal cell carcinoma of the skin are allowed.\n6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n\nInclusion criteria for controls:\n\n1. Age ≥18 years\n2. Newly diagnosed DLBCL with a high risk for relapse\u002Fprogression in the CNS or High-grade B-cell (HGBC) lymphoma with available clinical and radiological data, CSF and diagnostic histopathological specimen. 3. Newly diagnosed and\u002For relapsed SCNSL with available clinical and radiological data, CSF and diagnostic histopathological specimen. 4. Newly diagnosed lymphoma confined to CNS other than DLBC subtype 5. Neoplastic and non-neoplastic neurological disorders (neurodegenerative and neuroinflammatory disorders, toxic or infective encephalitis, primary CNS tumors other than lymphomas (mainly gliomas)) with available clinical and radiological data, CSF samples and, where possible, histo-pathological brain biopsy material formalin fixed and paraffin embedded.\n\n6\\. No contraindications to stereotactic or open brain biopsy and lumbar puncture; 7. Given written informed consent prior to any study specific procedures, with the understanding that the patient has the right to withdraw from the study at any time, without any prejudice.\n\nExclusion criteria for controls:\n\n1. Patients with extra-CNS lymphoma other than DLBC or HGBC subtypes, and not classified as high risk of CNS relapse;\n2. Any other serious medical condition which could impair the ability of the patient to participate in the trial;\n3. Pregnant and lactating female patients. Sexually active patients of childbearing potential must implement adequate contraceptive measures during study participation;\n4. Previous or concurrent malignancies at other sites diagnosed or relapsed within the last 3 years of follow-up. Patients with surgically cured in situ carcinomas and basal cell carcinoma of the skin are allowed;\n5. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.","18 Years",{"count":51,"type":21},70,[53],"NA","Thi is a prospective and low-intervention clinical trial. We propose to design a panel of \"core\" genetic alterations by sequencing Cerebral Spinal Fluid (CSF) DNA in patients with confirmed or suspicious Primary Central Neurvous System Lymphoma (PCNSL) with the aim to improve diagnostic sensitivity, response assessment and monitoring early CNS relapse in routine practice.\n\nEnrolled patients will receive conventional treatments according to well-established international guidelines, DNA assessments will not influence the treatment choices.",[27],[57,58,59],"PCNSL","ctDNA","CSF","2025-05-27",{"date":62,"type":32},"2025-05-31",{"date":64,"type":32},"2020-10-16",{"date":66,"type":21},"2027-04-30",{"name":68,"class":39},"IRCCS San Raffaele",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100363003","prospective-neurobehavioral-functions-in-newly-diagnosed-patients-with-primary-cns-lymphoma-treated-with-hyperfractionated-conformal-whole-brain-radiation-therapy-plus-simultaneous-integrated-boost-100363003","NCT04006561","Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost","Prospective Neurobehavioral Evaluation in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionated Conformal Whole-brain Radiation Therapy Plus Simultaneous Integrated Boost","Inclusion Criteria:\n\n* All patients must have a histopathologic diagnosis of non-Hodgkin's lymphoma (NHL) by brain biopsy\n* A typical MRI\u002FCT scan for primary CNS lymphoma is defined as the presence of hypo, iso, or hyperintense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)\n* Patients must have a normal or negative pre-treatment systemic evaluation including: i. A bone marrow aspirate and biopsy ii. CT scans of the chest, abdomen and pelvis iii. Patients must have adequate bone marrow reserve\n* Patients must be HIV-1 negative\n* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment\n\nExclusion Criteria:\n\n* A past history of major psychiatric disease\n* Prior cranial irradiation for any reasons\n* Other active primary cancer with the exception of basal cell carcinoma of skin and cervical carcinoma in situ\n* Pre-existing immunodeficiency such as renal transplant recipient","80 Years",{"count":78,"type":21},36,"OBSERVATIONAL","Primary central nervous system lymphoma (PCNSL) is an uncommon disease. Conventional treatment has consisted of either whole-brain radiation therapy (WBRT) or methotrexate (MTX)-based combined modality therapy integrating chemotherapy with cranial irradiation in a sandwiched manner. No matter whether the dosage of MTX is high or conventional, combining chemotherapy with WBRT greatly improves intracranial tumor control and even survival outcomes. However, delayed treatment-related neurotoxicity and neurocognitive sequelae emerged as a significant debilitating complication in PCNSL patients, especially when effective combined chemoradiation can achieve disease control and long-term survival rates. Therefore, by delivering hyperfractionated conformal WBRT plus SIB, this prospective cohort study aims to accomplish both optimal intracranial control and minimal WBRT induced neurocognitive decline. Additionally, by administering objective multi-domain neurobehavioral\u002Fneurocognitive assessments, the change in neurocognitive functions (NCFs) before and after the course of hyperfractionated conformal WBRT will be investigated and analyzed.\n\nAccording to the treatment guidelines for treating newly-diagnosed PCNSL patients, combined chemoradiation in which the WBRT course is sandwiched between initial courses of MTX and the later courses of chemotherapy with Ara-C is the treatment of mainstay at our institute. Employing the technique of a conformal CT treatment planning, the WBRT course is delivered in the manner of hyperfractionation with a reduced cumulative dose of 3600 cGy in 30 fractions during 3-4 weeks, administered twice daily in 1.2 Gy - fractions with at least 6 hours between fractions. By virtue of multidisciplinary management and teamwork including neurosurgery, hematology, radiation oncology, and neuroimaging expertise, it is attempted to recruit all potentially eligible patients with newly-diagnosed PCNSL. Most importantly, a professional neuropsychologist participates in this research project to integrate neurobehavioral outcomes into the prospective study. Accordingly, a battery of neuropsychological measures is used to evaluate predetermined NCFs for the studied patients. The test battery is composed of six standardized neuropsychological tests, covering four domains sensitive to disease and treatment effects (executive function, attention, verbal memory, information processing). The primary outcome measure is the change in patients' capability of information processing indicated by the Paced Auditory Serial Addition Test-Revised (PASAT-R), from the baseline before receiving the WBRT course to the follow-up after undergoing the entire courses of combined chemoradiation.\n\nThis prospective cohort study aims to thoroughly examine newly diagnosed PCNSL patients by using a standard battery of neurobehavioral\u002Fneurocognitive functions. Additionally, a better intracranial disease control is expected since the WBRT course relies on a highly conformal treatment planning integrated with the individualized arrangement of simultaneous integrated boost (SIB) to escalate the focal dose irradiating the originally involved site(s). Moreover, WBRT-related neurocognitive sequelae might be significantly less likely to occur because the WBRT course is delivered in the fashion of hyperfractionation, indicating a significantly lower dose per fraction and a reduced cumulative dose. Furthermore, it is anticipated the investigators will analyze which neurobehavioral domain would predict the treatment-related neurocognitive impacts to the largest extent in newly diagnosed PCNSL patients treated with cranial RT combined with or without MTX based chemotherapy according to the multidisciplinary treatment guidelines implemented at a single institute.",[27,82],"Brain Lymphoma",[27,84,85,86,87,88,89,90,91],"Neurobehavioral Assessment","Neurocognitive Function (NCF)","Whole-Brain Radiation Therapy (WBRT)","Simultaneous Integrated Boost (SIB)","Hyperfractionation","Radiotherapy","Chemotherapy","Neurotoxicity","2023-04-27",{"date":94,"type":32},"2023-05-01",{"date":96,"type":32},"2019-03-01",{"date":98,"type":21},"2029-02-18",{"name":100,"class":39},"Chang Gung Memorial Hospital",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":49,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":40},"100479084","phase-4-b-cell-mature-non-hodgkins-lymphoma-treatment-protocol-in-children-and-adolescents-2021-100479084","NCT05518383","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)","Inclusion Criteria:\n\n* Age at diagnosis 0 to 18 years.\n* The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL\n* Informed consent of the patient parents (guardians) to be treated\n\nExclusion Criteria:\n\n* previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency\n* hypersensitivity to rituximab or to ingredients of other IMPs.\n* no informed consent of the patient parents (guardians) to be treated","1 Day",{"count":110,"type":21},300,[112],"PHASE4","The aim of the trial is to evaluate the molecular characteristics and MDD\u002FMRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET\u002FCT in assessment of the completeness of remission.\n\nThe following primary study questions are going to be analyzed:\n\n* the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by \"second-line\" block VICI in order to improve results\n\nSecondary study questions will address\n\n* additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates\n* kinetics of immune reconstitution after treatment",[115,116,117,27,118],"Non-hodgkin Lymphoma,B Cell","Burkitt Lymphoma","Primary Mediastinal Lymphoma","Diffuse Large B-cell Lymphoma",[120,121,122,123,124,125,126],"B-cell mature non-Hodgkin's lymphoma","Burkitt's lymphoma","Diffuse large B-cell lymphoma","primary mediastinal lymphoma, primary CNS lymphoma","rituximab","children, adolescents","treatment","2022-08-25",{"date":129,"type":32},"2022-08-26",{"date":131,"type":32},"2022-05-25",{"date":133,"type":21},"2027-05-16",{"name":135,"class":39},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology"]