[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"central-nervous-system-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:central-nervous-system-lymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,73,98,130,152,180,202,234,261,282,309,338,371,387,411,433],{"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":35,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100054189","phase-2-daly-ii-usa-mb-cart20191-for-dlbcl-100054189",false,"NCT04792489","DALY II USA\u002F MB-CART2019.1 for DLBCL","A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and\u002For Refractory Diffuse Large B Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed B-cell non-Hodgkin's lymphoma:\n\n  * DLBCL cohort (both cohorts)\n* DLBCL or associated subtype, defined by WHO 2016 classification\n* DLBCL not otherwise specified (NOS)\n* High-grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements\n* High-grade B cell lymphoma (NOS)\n* Primary mediastinal (thymic) large B cell lymphoma\n* Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)\n\n  o CNS cohort\n* B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)\n\n  o Mantle Cell Lymphoma (MCL) cohort\n* Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation\n\n  o Richter's Transformation (RT) cohort\n* Histologically confirmed RT to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)\n* Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as:\n\nFor DLBCL cohort (after receiving at least two prior lines of therapy): persistent disease after failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either after failed ASCT, or ineligible, not intended for or not consenting to ASCT\n\n* Chemotherapy-refractory disease (applies to all cohorts) is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma\n* Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen\n\nFor disease specific cohorts added after the initial DLBCL cohort the definition of relapsed\u002Frefractory disease is as described below:\n\nCNS cohort: Subjects with relapsed\u002Frefractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.\n\n* First-line therapy is defined as either high dose methotrexatebased therapy, temozolomide, high dose cytarabine, pemetrexed, lenalidomide or Bruton tyrosine kinase (BTK) inhibitor-based therapy.\n* No contraindications for MRI evaluation\n* CNS cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy\n* Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and\u002For with or without an autologous stem cell transplant\n\nMCL cohort: Subjects with relapsed\u002Frefractory disease after at least one prior systemic treatment, that must include:\n\n* Cytotoxic rituximab \\[or equivalent\\] based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND\n* BTK inhibitor\n\nRT cohort: Subject must have relapsed\u002Frefractory disease after at least one prior systemic treatment following Richter's Transformation\n\nDLBCL transplant ineligible 2nd cohort: subject must have failure of first-line chemotherapy (including rituximab or equivalent and anthracycline).\n\n* For this cohort subjects are considered transplant ineligible if they meet one of the following criteria:\n* Age ≥70 years\n* ECOG status is 2 at screening\n* Impaired pulmonary function: diffusing capacity of the lung for carbon monoxide \\[DLCO\\] ≤ 60% adjusted for gender-specific hemoglobin concentration (Coates formula)\n* Impaired cardiac function: left ventricular ejection fraction (LVEF) \\\u003C 50%; must be assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 4 weeks of determination of eligibility\n* Impaired renal function: calculated creatinine clearance (Cockcroft and Gault) \\\u003C 60 mL\u002Fmin\n* Impaired hepatic function: aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 2 x upper limit of normal (ULN)\n\nIn addition, all subjects must have:\n\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to lymphoma\n\n  * Subjects in DLBCL transplant-ineligible 2nd-line cohort with ECOG performance status of 2, regardless of attribution, will be allowed for inclusion\n* Measurable disease will be assessed by FDG-PET\u002FCT in systemic lymphoma . and by brain\u002Fspine MRI for CNS disease\n* Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion. If medically not feasible to obtain a biopsy from the most recent relapse and for cases when the amount of tissue is limited, the sponsor should be consulted, to confirm adequacy of the sample for study required analyses\n* No clinical suspicion of central nervous system (CNS) lymphoma (not applicable to CNS cohort)\n\n  * Subjects in DLBCL transplant-ineligible 2nd-line cohort with SCNSL will be allowed for inclusion\n* If the subject has history of CNS disease (not applicable to CNS cohort), then he\u002Fshe must have no signs or symptoms of CNS disease, have no active disease on magnetic resonance imaging (MRI), have no large cell lymphoma present in cerebral spinal fluid (CSF), regardless of the number of white blood cells (WBCs)\n* If has history of cerebral vascular accident (CVA), the CVA event must be greater than 12 months prior to leukapheresis. Any neurological deficits must be stable\n* A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) \\> 45mL\u002Fmin\n* Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)\n* Subjects in DLBCL transplant-ineligible 2nd-line cohort with a lower ejection fraction of \\> 40% will be allowed for inclusion\n* Resting O2 saturation \\>90% on room air\n* Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST)\\\u003C5 times the Upper Limit of Normal (ULN) for age\n* Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n* Subjects in DLBCL transplant-ineligible 2nd-line cohort with a total bilirubin of \\\u003C 2.0 mg\u002FdL will be allowed for inclusion\n* Absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Absolute lymphocyte count \\> 100\u002FμL\n* Platelet count \\> 50,000\u002FµL\n* Estimated life expectancy of more than 3 months other than primary disease\n\nExclusion Criteria:\n\n* Primary CNS lymphoma (not applicable to CNS cohort)\n* Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL) (not applicable to RT cohort)\n* Unable to give informed consent\n* Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be quantitative polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive\n* Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* Pharmacologically uncontrolled seizures.\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory disease\n* Presence of CNS disorder that, in the judgment of the Investigator, may impair the ability to evaluate neurotoxicity. For CNS Cohort:\n\n  * For CNSL and DLBCL transplant-ineligible 2nd-line cohort patients that have a CNS lesion(s): Midline shift on MRI or Abnormal high CSF opening pressure and or CSF protein ≥150 mg\u002FdL Recent (within 3 months) whole brain radiotherapy (WBRT) are exclusionary\n* Active systemic fungal, viral, or bacterial infection\n* Pregnant or breast-feeding woman\n* Previous or concurrent malignancy with the following exceptions:\n\n  * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to study entry)\n  * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study\n  * Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years\n  * A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n* Severely immunocompromised subjects e.g., due to current treatment of non-neurologic autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).\n* Medical condition requiring prolonged use of systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday. For CNS cohort: Up to 2 mg\u002Fday dexamethasone (or equivalence) may be allowed at any time, higher doses allowed up to 7 days prior to apheresis or after apheresis until lymphodepletion.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* Concurrent radiotherapy (allowed up to time of lymphodepletion). For prior systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.\n* Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Refusal to participate in additional lentiviral gene therapy long-term follow-up (LTFU) protocol\n* Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma\n* Prior allogeneic stem cell transplant for any indication\n* Prior Bispecific T cell engaging (BITE) antibodies for cancer therapy\n* Prior T cell receptor-engineered T cell therapy","ALL","18 Years",{"count":19,"type":20},315,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.",[26,27,28,29,30,31,32,33,34],"Refractory Diffuse Large B Cell Lymphoma (DLBCL)","Relapsed Diffuse Large B Cell Lymphoma","High Grade B-cell Lymphoma (HGBCL)","Primary Mediastinal B-cell Lymphoma (PMBCL)","Transformed Lymphoma","Central Nervous System Lymphoma","Mantle Cell Lymphoma (MCL)","Richter Transformation","Transplant-ineligible 2nd Line DLBCL",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"CD19\u002FCD20-directed CAR-T Cells","Zamtocabtagene autoleucel","B-Cell Non-Hodgkin Lymphoma","Primary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma","NHL","PCNSL","SCNSL","Chimeric Antigen Receptor","CAR","CAR-T Cell","Autologous T Cell Therapy","Central Nervous System Neoplasms","Lymphoma","Lymphoma, Non-Hodgkin","Lymphoma, B-Cell","Lymphoma, Large B-Cell, Diffuse","MCL","RT","CLL","Immunotherapy","T cells","T cell infusion","transplant-ineligible 2nd line DLBCL","RECRUITING","2026-07-09",{"date":63,"type":64},"2026-07-13","ACTUAL",{"date":66,"type":64},"2021-05-25",{"date":68,"type":20},"2028-12-31",{"name":70,"class":71},"Miltenyi Biomedicine GmbH","INDUSTRY",32,{"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":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100562775","phase-1-loncastuximab-tesirine-and-rituximab-following-stereotactic-radiosurgery-in-patients-with-central-nervous-system-lymphomas-solar-100562775","NCT06607549","Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery in Patients With Central Nervous System Lymphomas (SOLAR)","A Phase 1 Study of Loncastuximab Tesirine and Rituximab Following Stereotactic Radiosurgery (SRS) in Patients With Primary and Secondary Central Nervous System Lymphomas","SOLAR","Inclusion Criteria:\n\n* Participant aged ≥ 18 years\n* ECOG Performance Status ≤ 3\n* Histologically confirmed primary CNS lymphoma or secondary diffuse large B-cell lymphoma (DLBCL) with CNS involvement with either:\n\n  * Relapsed or refractory disease with at least 1 prior therapy OR\n  * Ineligible for high-dose methotrexate-based therapy as determined by the treating physician, including previously untreated patients. Examples of medical conditions for which a patient could be considered ineligible for high-dose methotrexate include but not limited to renal impairment, liver disease, heart failure.\n\n    * Note: For patients with a history of histologically documented systemic DLBCL with CNS relapse, a biopsy of the CNS lesion is recommended but not required.\n* Must be a candidate for SRS. Lesion size must be \\\u003C 6 cm and the number of lesions must be \\\u003C 10.\n* Must have evaluable disease. This includes radiographic evidence of parenchymal disease or parenchymal disease and disease detected in the CSF.\n\n  * Patients with vitreous or retinal involvement alone are not eligible.\n  * Patients with leptomeningeal disease or spinal cord disease are not eligible.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count ≥ 1000 cells\u002Fmm3 (1.00 x 109\u002FL) independent of G-CSF support (i.e. no G-CSF within the past 3 days) unless there is documented bone marrow involvement.\n    * Platelet count ≥ 75,000 cells\u002Fmm3 (75 x 109\u002FL) independent of transfusion support (i.e. no transfusion within the past 3 days) unless there is documented bone marrow involvement.\n    * Hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL) independent of transfusion support (i.e. no transfusion within the past 3 days) unless there is documented bone marrow involvement.\n  * Hepatic:\n\n    ---Total bilirubin ≤ 2.0 mg\u002FdL (unless bilirubin rise is due to Gilbert's syndrome), if total bilirubin is \\> 2.0 mg\u002FdL, the subject is eligible for the study if the direct bilirubin is normal; transaminases (AST\u002FALT) ≤2.5 x upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 30 mL\u002Fmin by Cockcroft-Gault formula:\n\n      * Males: ((140-age)×weight\\[kg\\])\u002F(serum creatinine \\[mg\u002FdL\\]×72)\n      * Females: (((140-age)×weight\\[kg\\])\u002F(serum creatinine \\[mg\u002FdL\\]×72))×0.85\n* For subjects of childbearing potential: Negative pregnancy test or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n* Female participants of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1 until 10 months after last dose of loncastuximab tesirine and 12 months after the last dose of rituximab. Male participants with female partners of childbearing potential must agree to use a highly effective method of contraception when sexually active until 7 months after the last dose of loncastuximab tesirine.\n* Provide written informed consent and comply with the study protocol as judged by the Investigator. Of note, if the subject has an impairment that prevents him\u002Fher from providing consent, the site may follow approved institutional procedures for obtaining consent. The investigator should document when a potential or current participant lacks decision-making capacity and thus requires an LAR to provide consent.\n\nExclusion Criteria:\n\n* Concurrent use of other approved or investigational antineoplastic agents (with the exception of corticosteroids).\n* History of intracranial hemorrhage or clinically significant stroke within 6 months prior to enrollment\n* History of prior radiation to the CNS.\n* Significant medical diseases or conditions, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction in the past 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, severely immunocompromised state, and congestive heart failure, New York Heart Association Class III-IV.\n* Known bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.\n* Known Human immunodeficiency virus (HIV) infection.\n* Prior allogeneic stem cell transplant (autologous stem cell transplant is NOT an exclusion).\n* Prior exposure to loncastuximab tesirine\n* Chemotherapy or targeted small molecule therapy (or other therapy for CNS lymphoma) within 3 weeks prior to the first day of study treatment (or 5 half-lives (whichever is shorter), or 2 weeks prior to the first day of study treatment for monoclonal antibodies.\n* The patient must have recovered to baseline or ≤ grade 1 from prior toxicities of therapy with the exception of alopecia and myelosuppression provided lab criteria met. Recovery to ≤ grade 2 neuropathy is permitted.\n* Cellular therapy within 8 weeks.\n* Presence of clinically significant pericardial or pleural effusions, or third space fluid accumulations (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).\n* Congenital long QT syndrome or a corrected QT measure (QTc) interval of \\>480 ms at screening (unless secondary to pacemaker or bundle branch block).\n* Known history of hypersensitivity to CD19 antibody and\u002For, components of study medication.\n* All subjects must be screened for hepatitis B and C. Patients with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Patients who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing. Subjects with active Hep C patients may be enrolled if other parameters precluding hepatic impairment are met and they are not undergoing active therapy for hepatitis C.\n* Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening.\n* Subjects with chronic liver disease with hepatic impairment Child-Pugh class C\n* Pregnant or lactating or intending to become pregnant during the study.\n* Patients diagnosed with another malignancy within three years or with any evidence of residual prior malignant disease (except nonmelanoma skin cancer, non-metastatic prostate cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ). Patients meeting this exclusion criteria may be enrolled after approval from study PI.\n* Unable to tolerate corticosteroids",{"count":82,"type":20},12,[84],"PHASE1","The purpose of this clinical trial is to learn if drugs loncastuximab tesirine and rituximab (lonca-R) after stereotactic radiosurgery are safe and effective for treatment of central nervous system lymphomas.",[31],"2026-06-24",{"date":89,"type":64},"2026-06-29",{"date":91,"type":64},"2025-03-18",{"date":93,"type":20},"2030-11",{"name":95,"class":96},"University of Utah","OTHER",3,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":114,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100599313","phase-1-a-study-of-epcoritamab-and-ibrutinib-in-people-with-central-nervous-system-lymphoma-cnsl-100599313","NCT07082868","A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)","A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory\u002FRecurrent CNS Lymphoma (EIFEL-Trial)","Inclusion Criteria:\n\n* \\>\u002F= 18 years of age on the day of consenting to the study.\n* Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)\n* Participants must have an ECOG performance status of 0, 1, or 2.\n* Participants must have adequate bone marrow and organ function shown by:\n\n  * Absolute neutrophil count (ANC) ≥ 1 x 109\u002FL\n  * Platelets ≥ 75 x 109\u002FL and no platelet transfusion within the past 21 days prior to study consent\n  * Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 21 days prior to study consent\n  * International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal (unless receiving anticoagulation)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal\n  * Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.\n  * Creatinine clearance (CLCr) ≥ 30 ml\u002Fmin (based on the following formular Creatinine clearance= ((140-age)\\*wt)\u002F(creatinine\\*72); multiply by 0.85 for women)\n* Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose\n* Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry. See section on Pregnancy and Reproduction.\n\n  * Patients must be able to tolerate MRI\u002FCT scans.\n  * Due to the nature of this disease, we will allow patients with impaired decision-making ability to enroll into all cohorts.\n\nExclusion Criteria:\n\n* Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.\n* Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded\n* Patient is concurrently using other approved or investigational antineoplastic agents.\n* Patient has an active concurrent malignancy requiring active therapy\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 prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.\n* Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.\n* Patient requires more than 8 mg of dexamethasone daily or the equivalent\n* Patient is using warfarin or any other warfarin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed. Patients with congenital bleeding diathesis are excluded.\n* Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit for at least 3 days prior to Cycle 1 Day 1\n* Patient is taking a drug known to be a moderate or strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450\u002FCYP3A inhibitors and inducers for at least 5 half-lives or at least two weeks, whichever is shorter, prior to starting the study drug.\n* Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of \\> 5 mg\u002Fday of prednisone or the equivalent (for more than 12 months). Participants must be off of immunosuppressant therapy for at least 28 days prior to the first dose of the study drug.\n* Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening\n* Patient has an ejection fraction of \\\u003C50%\n* Patient has a known bleeding diathesis (e.g. von Willebrand's disease) or hemophilia.\n* Patient is documented to have human immunodeficiency virus (HIV) infection.\n* Patient is documented to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests.\n* Patient is known to have an uncontrolled active systemic infection.\n* Patient is unable to swallow capsules or has a disease or condition significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.\n* Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.\n* Patient has not received vaccination with live vaccines within 28 days prior to first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the last dose of study treatment. Note: COVID-19 non-replicating adenoviral vaccines are permitted with a minimum period of 3 days between the vaccine and a dose of study drug. It is highly recommended that every patient enrolled onto this trial has updated vaccination status (e.g. flu, hepatitis, polio, pertussis, tetanus; when is doubt please contact the PI or side-PI).\n* Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum hCG laboratory test of \\> 5 mIU\u002FmL\n\nPregnancy and Reproduction\n\nWomen:\n\n* Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \\>40 mIU\u002FmL and estradiol \\\u003C 20 pg\u002FmL or have had surgical bilateral oophorectomy with or without hysterectomy at least six weeks prior to enrollment in the study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up of hormone level assessment is she considered not of childbearing potential.\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 4 months after study discontinuation. Highly effective contraception is defined as either\n\n  * True abstinence: When this is the line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Sterilization: Surgical bilateral oophorectomy, with or without hysterectomy, or tubal ligation at least six weeks prior to study enrollment.\n  * Male partner sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female patients participating in the study, the vasectomized male partner should be the sole partner for that patient.\n  * Use of a combination of any two of the following:\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n* Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal form\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository\n* Women of child-bearing potential must have one negative serum pregnancy tests at screening\n* In addition to having a negative pregnancy test confirmed at screening, all female participants of child bearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug.\n\nMen:\n\n* Fertile males, defined as all male subjects physiologically capable of conceiving offspring, must use a condom during study treatment and for 4 months after study discontinuation and should not father a child in this period.\n* Female partner of a male study subject should use a highly effective method of contraception while the male partner is receiving the study agent and for 4 months after the final dose of the study therapy.\n\nInclusion of women, minorities or other underrepresented populations\n\n* Ibrutinib and epcoritamab are not known to differentially affect subpopulations, including women, minorities, or other underrepresented groups. The eligibility and exclusion criteria are not expected to differentially impact recruitment or retention of these subpopulations.\n\nCovid-19 eligibility criteria\n\nSubject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection.\n\nSubjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n* No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n* Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart\n\nGiven the ongoing COVID-19 pandemic, selected non-live vaccines (e.g. mRNA, non-replicating viral vector, protein subunit, etc.) to prevent SARS-CoV-2 infections may be administered during screening or the treatment period, as long as components of the vaccine are not contraindicated. COVID-19 vaccines are permitted and strongly recommended.\n\nThe decision to receive a locally available vaccine should be based on local guidance and an individual discussion between the treating physician and the subject.\n\nThe potential impact of epcoritamab on SARS-CoV-2 vaccination is unknown. Therefore, study drug should be administered as follows:\n\n* The first dose of study drug, when possible, is preferred to be given at least 14 days from SARS-CoV-2 vaccine administration.\n* A minimum period of 3 days must occur between the administration of an appropriate COVID-19 vaccine and the administration od epcoritamab (to avoid overlapping AEs).\n\nNote: The above guidance applies to all SARS-CoV-2 vaccine doses given as part of the complete vaccination course.\n\nThese recommendations may be subject to change based on the evolving knowledge around the use of SARS-Cov-2 vaccines in subjects with recurrent\u002Frefractory DLBCL or cFL and as more data are collected in real-world scenarios and clinical trials.",{"count":106,"type":20},26,[84],"The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed\u002Frefractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).",[110,39,111,112,31,40,113],"Primary Central Nervous System Lymphoma (PCNSL)","Relapsed Primary Central Nervous System Lymphoma","Refractory Primary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma (SCNSL)",[39,42,115,116,31,40,43,117,118,119,120],"Relapsed Primary Central Nervous Lymphoma","Refractory Primary Central Nervous Lymphoma","epcoritamab","ibrutinib","25-032","Memorial Sloan Kettering Cancer Center","2026-06-10",{"date":123,"type":64},"2026-06-11",{"date":125,"type":64},"2025-08-13",{"date":127,"type":20},"2028-08",{"name":120,"class":96},8,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100487323","phase-1-intracerebroventricular-administration-of-cd19-car-t-cells-cd19car-cd28-cd3zeta-egfrt-expressing-tnmem-t-lymphocytes-for-the-treatment-of-central-nervous-system-lymphoma-100487323","NCT05625594","Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn\u002FMem T-lymphocytes) for the Treatment of Central Nervous System Lymphoma","A Phase 1 Study to Evaluate Intracerebroventricular (ICV) Administration of CD19-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With CNS Lymphoma","Inclusion Criteria:\n\n* Participant must have the ability to understand and the willingness to sign a written informed consent\n\n  * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter\u002Ftranslator to proceed with screening and leukapheresis, while the request for a translated full consent is processed. However, the research participant can proceed with lymphodepletion (if applicable) and CAR T cell infusion only after the translated full consent form is signed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with study principal investigator (PI) approval\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2\n* Documented primary CNS lymphoma. Progression must be determined radiographically. Participant must have measurable disease which could be a measurable lymphomatous mass or, in the case of leptomeningeal only disease, measurable lymphoma cells in CSF by flow cytometry\n\n  * Patients with secondary CNS lymphoma with CNS only relapse, confirmed by PET-CT, may also be eligible, per PI discretion.\n* Documented current CD19+ tumor expression if prior CD19 directed therapy was used\n* Participant must have received and failed or have been intolerant to CNS directed therapy like high dose methotrexate or high dose cytarabine based regimens. Participants are not required to have failed all of these agents if, in the investigator's opinion, they would benefit from treatment on the current protocol\n* Prior CAR T cell therapy is allowed if at least 3 months have elapsed prior to leukapheresis procedure\n\n  * If participant received prior CD19-CAR T cells persistence must be evaluated and found to be \\\u003C5% prior to leukapheresis procedure\n* No known contraindications to leukapheresis, steroids or tocilizumab\n* Participant of reproductive potential must agree to use acceptable birth control methods throughout study therapy and for 3 months after final dose of study treatment\n* Total serum bilirubin =\\\u003C 2.0 mg\u002FdL (within 14 days of signing the screening and leukapheresis consent)\n\n  * Patients with Gilbert syndrome may be included if their total bilirubin is =\\\u003C 3.0 x upper limit of normal (ULN) and direct bilirubin =\\\u003C 1.5 x ULN\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (within 14 days of signing the screening and leukapheresis consent)\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (within 14 days of signing the screening and leukapheresis consent)\n* Creatinine clearance of \\>= 50 mL\u002Fmin per the Cockcroft-Gault formula (within 14 days of signing the screening and leukapheresis consent)\n* Cardiac function (12 lead-electrocardiogram \\[ECG\\]) without acute abnormalities requiring investigation or intervention (within 14 days of signing the screening and leukapheresis consent)\n* Absolute neutrophil count \\>= 750\u002FuL (within 14 days of signing the screening and leukapheresis consent)\n* Hemoglobin (Hb) \\>= 8 g\u002Fdl (within 14 days of signing the screening and leukapheresis consent)\n* Platelet count \\>= 50,000\u002FuL (within 14 days of signing the screening and leukapheresis consent)\n* Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) \\> 40% (evaluation within 6 weeks of screening does not need to be repeated) (within 14 days of signing the screening and leukapheresis consent)\n* Oxygen (O2) saturation \\> 92% not requiring oxygen supplementation (within 14 days of signing the screening and leukapheresis consent)\n* Seronegative for HIV qPCR, HCV\\*, active HBV (Surface Antigen Negative), and syphilis (RPR)\n\n  * If positive, Hepatitis C RNA quantitation must be performed. OR\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n\nMeets other institutional and federal requirements for infectious disease titer requirements Note Infectious disease testing to be performed within 28 days prior to enrollment.\n\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days of signing the screening and leukapheresis consent)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\nExclusion Criteria:\n\n* Participant has not yet recovered from toxicities of prior therapy\n* Presence of systemic lymphoma\n* Participant with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of signing the screening and leukapheresis consent\n* Participant with known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Needing dexamethasone more than 4mg\u002Fday (or equivalent) within 72 hours prior to leukapheresis or CAR T cell infusion\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition or other agents used in this study\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to signing the screening and leukapheresis consent\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent with no known active disease present for \\>= 3 years, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\n* Uncontrolled active infection\n* Active hepatitis B or hepatitis C infection: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded\n\n  * Subjects who are hepatitis B core antibody positive (or have a known history of hepatitis B virus \\[HBV\\] infection) should be monitored quarterly with a quantitative PCR test for HBV deoxyribonucleic acid (DNA). HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core antibody (Ab) positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment\n  * Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded\n* Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded\n* Human immunodeficiency virus (HIV) infection\n* Active significant bacterial, fungal or viral (other than those listed) infections\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":138,"type":20},20,[84],"This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with CNS lymphoma than giving them via other methods.",[31],"2026-06-01",{"date":144,"type":64},"2026-06-03",{"date":146,"type":64},"2023-06-29",{"date":148,"type":20},"2028-05-22",{"name":150,"class":96},"City of Hope Medical Center",1,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":151},"100638300","phase-1-golcadomide-with-pemetrexed-rituximab-and-dexamethasone-for-relapsed-and-refractory-cns-lymphomas-100638300","NCT07608731","Golcadomide With Pemetrexed, Rituximab, and Dexamethasone for Relapsed and Refractory CNS Lymphomas","Phase I Pilot Trial of Golcadomide With Pemetrexed, Rituximab, and Dexamethasone for Relapsed and Refractory CNS Lymphomas","Inclusion Criteria:\n\n* Participants or their legally acceptable representative must have signed and dated an IRB approved written ICF in accordance with regulatory, local, and institutional guidelines.\n* Participants ≥ 18 years of age.\n* Confirmed histopathological diagnosis of aggressive malignant B-cell lymphoma based upon a representative histology specimen according to the WHO classification. For participants with secondary CNS lymphoma, this can be confirmed by prior systemic biopsy. If a CNS lesion was not amenable for biopsy, imaging (e.g. MRI Brain ± MRI Full Spine) with CSF analysis for cytology may be used to confirm diagnosis, in lieu of a biopsy. Required. Acceptable histologies include:\n\n  * Large B-cell lymphoma NOS\n  * Diffuse large B-cell lymphoma (including GCB and ABC types)\n  * High-grade B-cell lymphoma with MYC and BCL2 rearrangements (double hit lymphomas)\n  * High-grade B-cell lymphoma NOS\n  * T-cell\u002Fhistiocyte\u002Frich large B-cell lymphoma (THRLBCL)\n  * EBV + DLBCL\n  * PMBCL\n  * Follicular Large B-Cell (previously referred to as Follicular Lymphoma, Grade 3B)\n* Participants must have active CNS lymphoma for which this trial is planned. Confirmation of the histology in relapsed setting is not required but participants must have measurable disease per the International PCSNL Collaboration Group Criteria (Section 11.1), as evidenced by at least one of the following:\n\n  * CNS disease on MRI (brain or spine including parenchymal and leptomeningeal)\n  * Detectable in the CSF\n  * Detectable on ophthalmologic exam\n* Participants must have received ≥ 1 prior systemic therapy for treatment of their CNS lymphoma. Participants who had systemic lymphoma and then relapsed with secondary CNS lymphoma must have received at least one prior line of therapy to specifically treat the CNS lymphoma.\n* Participants must have received prior high dose methotrexate as a line of therapy OR have been ineligible for methotrexate therapy based on the investigator's discretion.\n\n  * Participants who have received methotrexate as their first line of therapy but are no longer eligible for ongoing methotrexate and have persistent disease are eligible\n* ECOG performance status ≤ 0-3. PS 3 is allowed if it is disease related and not due to comorbidities or frailty and PS 4 is allowed if it is from CNS causing motor weakness and not due to comorbidities or frailty. (see Appendix I)\n* Adequate bone marrow function, defined by the following laboratory parameters:\n\n  * Absolute neutrophil ≥ 1.5 x 109\u002FL\n* Platelet count ≥ 100 x 109\u002FL\n\n  * Hemoglobin ≥ 8 g\u002FdL\n* Adequate organ function, defined by the following laboratory parameters:\n\n  * Adequate hepatic function, with transaminases (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], and gamma glutamyl transferase \\[GGT\\]) ≤ 2.5 times the 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* Calculated creatinine clearance \\> 45 mL\u002Fmin by the Cockcroft-Gault equation.\n* Treating investigator must specify at screening:\n\n  * If the intent of therapy is a bridge to cellular therapy or to complete all six cycles of therapy. If bridge to cellular therapy is planned, the type of cellular therapy should also be specified at this time.\n  * If the r\u002Fr CNS lymphoma is primary or secondary\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two methods of contraception simultaneously from signing the ICF, at least 28 days before starting golcadomide, throughout the study, for up to 28 days following the last dose of golcadomide, and for 12 months after the last dose of rituximab, whichever is longer.. Two methods of contraception must include one highly effective method and one additional effective (barrier method).\n\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and\u002For uterus).\n\n    * Examples of contraceptive methods include highly effective methods such as oral, injectable, or implantable hormonal contraceptive; tubal ligation; intrauterine device; vasectomized partner and barrier methods with spermicide.\n    * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Must agree to pregnancy testing per protocol. This applies even if the participant practices true abstinence from heterosexual contact.\n    * Agree to abstain from breastfeeding or providing breast milk while on golcadomide and 28 days after discontinuation of golcadomide and according to the approved\n  * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * 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 28 days after the last dose of study intervention or 90 days for rituximab, whichever is longer. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 28 days after the last dose of study intervention or 90 days for rituximab, whichever is longer.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Prior treatment toxicities not resolved to grade \\\u003C 2 according to NCI CTCAE 6.0 (with the exception of alopecia or grade 2 sensory peripheral neuropathy).\n* Participants receiving any other investigational agents.\n* History of anaphylactic reactions or severe allergic reactions prohibiting further administration attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in this study.\n* Autologous stem cell transplant within 30 days of start of study drug (C1D1).\n* CAR T-cell therapy within 90 days of start of study drug (C1D1).\n* Previous allogeneic stem cell transplant\n* Women who are pregnant or breastfeeding.\n* Clinically significant autoimmune disease.\n* Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus.\n* Malabsorption syndrome or other conditions that precludes enteral route of administration.\n* Chemotherapy or radiation within 2 weeks of the first scheduled study treatment\n* Participant is currently receiving warfarin. Particpants may begin screening if the plan is to change to an alternative anticoagulant such as a DOAC prior to enrollment.\n* Participant has current treatment with strong cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) modulators. The washout period for strong CYP3A4\u002F5 modulators is 7 days or 5 half-lives (whichever is longer) before initiation of golcadomide.\n* 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. Note: participants 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.\n  * Other uncontrolled conditions including uncontrolled cardiovascular disease or arrhythmia, decompensated diabetes or COPD.",{"count":160,"type":20},18,[84],"This research study is for people who have been diagnosed with large B-cell lymphoma of the central nervous system (CNS), which has either returned or is not responding to current treatment. Goldcadomide is a new experimental drug that works by binding to a specific protein inside cancer cells and helps stimulate immune cells that help fight cancer cells. It also has the ability to enter the central nervous system. It has shown promising safety and effectiveness when combined with standard of care chemotherapy. Participants will be treated with this study drug combined with standard of care chemotherapy. Participation in the research will last about 2.5 years. The purpose of this study is to help researchers learn if the study drug, Golcadomide, in combination with the standard of care regimen is a safe and effective way to treat large B-cell lymphoma with CNS involvement.",[164,31],"Large B-cell Lymphoma",[166,167,168,169],"Golcadomide","Pemetrexed","Rituximab","Dexamethasone","NOT_YET_RECRUITING","2026-05-20",{"date":173,"type":64},"2026-05-27",{"date":175,"type":20},"2026-06",{"date":177,"type":20},"2029-09",{"name":179,"class":96},"Allison Winter",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":151},"100440111","neurocognitive-outcomes-after-whole-brain-radiation-therapy-for-hematologic-malignancies-100440111","NCT05011045","Neurocognitive Outcomes After Whole Brain Radiation Therapy for Hematologic Malignancies","Inclusion Criteria:\n\n* Age 18 years or older\n* Treatment with radiation therapy to the brain for a hematologic malignancy (ex. primary central nervous system lymphoma \\[PCNSL\\], secondary central nervous system lymphoma \\[SCNSL\\], leukemia, myeloma)\n* Proficient and capable of completing tests in English\n* Patients with claustrophobia are eligible if the claustrophobia is managed with medication\n* Patients with cognitively-impairment are eligible if the impairment is managed with medication\n* Patients who are pregnant",{"count":187,"type":20},100,"OBSERVATIONAL","This study assesses neurocognitive outcomes after receiving radiation therapy to the brain (whole brain radiation therapy) in patients with blood cancers (hematologic malignancies). This may help researchers learn more about the effects of whole brain radiation therapy on memory and thinking in patients with blood cancer.",[31,191,192,49,193,40],"Hematopoietic and Lymphoid Cell Neoplasm","Leukemia","Plasma Cell Myeloma","2026-05-18",{"date":171,"type":64},{"date":197,"type":64},"2020-01-09",{"date":199,"type":20},"2026-10-31",{"name":201,"class":96},"M.D. Anderson Cancer Center",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":220,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":151},"100376822","phase-1-car-2019-t-cells-in-patients-with-relapsed-refractory-b-cell-malignancies-100376822","NCT04186520","CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies","Phase I\u002FII Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and\u002For Refractory B Cell Malignancies","GENERAL INCLUSION CRITERIA FOR ALL PATIENTS\n\n1. Patients must be aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma.\n2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm\\^3.\n3. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment EXCEPT Arm E subjects.\n4. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL (see separate criteria for CLL and primary\u002Fsecondary CNS lymphoma).\n5. Karnofsky performance score ≥70.\n6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n7. ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days.\n8. Platelets≥50,000 with no transfusion within 72 hours.\n9. Adequate renal function, defined as creatinine clearance \\>60 ml\u002Fmin AND serum Cr≤1.5 mg\u002FdL.\n\n   a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure within three months of planned CAR infusion.\n10. Able to provide written informed consent.\n11. Agree to practice birth control during the study.\n12. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n13. Expected survival \\>12 weeks.\n14. Negative urine or serum pregnancy test in females of child bearing potential at study entry.\n15. Meet criteria regarding fertility and contraception.\n16. No contraindication to central line access.\n17. Patient has demonstrated compliance to other therapies.\n\nPhase 1: 3+3 COHORT ELEGIBILITY CRITERIA\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria.\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant\n   3. Relapse post-allogeneic transplant\n   4. Patients not previously treated with CAR-T cell therapy\n\nPHASE 1b and 2 COHORT ELEGIBILITY CRITERIA\n\nARM A: Six to nine patient expansion with 8-day manufacturing (Phase 1b)\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant.\n   3. Relapse post-allogeneic transplant.\n   4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy.\n\n   i. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM B: Six to nine patient expansion with 12-day manufacturing (Phase 1b)\n\n1\\. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n\n2\\. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n4. Relapse post-anti-CD19 CAR-T cell therapy.\n\ni. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM C: 24 patient cryopreservation 8\u002F12 flexible manufacturing arm\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria a. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant b. Relapse post-autologous transplant c. Relapse post-allogeneic transplant d. Relapse post-anti-CD19 CAR-T cell therapy i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort\n\nARM D: Phase 1 and Phase 1b: CLL\n\n1\\. Diagnosis of B-cell CLL or small lymphocytic leukemia (SLL) 2. Failed\u002Fprogressed or been intolerant to two prior lines of therapy one of which MUST be either a covalent BTK inhibitor (e.g. ibrutinib, acalabrutinib, zanabrutinib, etc) or BCL2 inhibitors (e.g. venetoclax or other investigational BCL2) 3. Indication for treatment as defined as any of the following:\n\n1. measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and\u002For hepatomegaly or splenomegaly)\n2. bone marrow involvement with ≥10% CLL involvement\n\nARM E: Phase 1 and Phase1b Relapsed\u002FRefractory Primary or Secondary CNS Lymphoma\n\n1. Diagnosis of diffuse large B cell lymphoma (DLBCL) with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation) with secondary CNS lymphoma involvement OR primary CNS lymphoma.\n2. For Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy.\n3. Secondary CNS lymphoma relapsed or refractory following at least one line of CNS-directed therapy for treatment of CNS lymphoma.\n\n   1. For patients with secondary central nervous system lymphoma (CNSL) with concurrent systemic lymphoma, the concurrent systemic lymphoma must have relapsed following at least 1 prior line of therapy (which must have included an anti-CD20 monoclonal antibody and an anthracycline)\n4. Measurable CNS disease by either lumbar puncture (LP) with positivity in CNS by flow cytometry or morphology for lymphoma cells OR magnetic resonance imaging (MRI) with enhancing lesions ≥1 cm in size consistent with lymphoma\n5. Must have had prior treatment with high dose methotrexate defined as methotrexate given intravenously at a dose ≥2500 mg\u002Fm\\^2 and either progression\u002Frelapse, stable disease, or intolerance to at least one cycle of treatment.\n\nPhase II Cohort: Mantle Cell Lymphoma\n\n1\\. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously defined and have relapsed, refractory disease as defined as one of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line Bruton tyrosine kinase (BTK) inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n5. Relapse post anti-CD19 CAR-T cell therapy.\n\ni. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort.\n\nEXCLUSION CRITERIA (ALL PATIENTS)\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta- human chorionic gonadotropin (HCG) in female of childbearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n6. Refusal to participate in the long-term follow-up protocol\n7. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture (Not applicable to Arm E cohort.)\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Prior allogeneic CAR T-cell therapy\n10. Previous recipients of autologous CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec)\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry\n11. Anti-CD20 antibody treatment within 4 weeks of cell infusion\n12. Anti-CD19 antibody treatment within 4 weeks of cell infusion\n13. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells\n15. Oral chemotherapeutic agents or antibody directed treatment within 7 days of apheresis\n\n    a. BTK inhibitors are allowed until 1-day prior to apheresis and can re-start until 1-day prior to lymphodepletion\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002Ffollicular lymphoma (FL)\u002Fmarginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma)\n\nSPECIAL CRITERIA REGARDING FERTILITY AND CONTRACEPTION\n\nFemale subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of eligibility criteria Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device (IUD)\n* Hormonal-based contraception Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception","80 Years",{"count":187,"type":20},[84,23],"This is a Phase I\u002FII, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7\u002FIL-15) manufactured chimeric antigen receptor (CAR)-20\u002F19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.",[214,32,215,216,217,218,219,31],"Non Hodgkin Lymphoma (NHL)","Chronic Lymphocytic Leukemia (CLL)","Follicular Lymphoma","Marginal Zone Lymphoma","Diffuse Large B Cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[221,222,223,224],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","B-cell Malignancies","2026-02-19",{"date":227,"type":64},"2026-02-23",{"date":229,"type":64},"2020-05-18",{"date":231,"type":20},"2029-02-28",{"name":233,"class":96},"Medical College of Wisconsin",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":151},"100624996","phase-2-thiotepa-in-combination-with-pirtobrutinib-a-btk-inhibitor-and-sintilimab-a-pd-1-inhibitor-for-frail-or-relapsedrefractory-primary-or-secondary-central-nervous-system-lymphoma-100624996","NCT07416890","Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","A Prospective, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of Thiotepa in Combination With Pirtobrutinib (a BTK Inhibitor) and Sintilimab (a PD-1 Inhibitor) for Frail or Relapsed\u002FRefractory Primary or Secondary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Histopathologically confirmed relapsed primary central nervous system lymphoma (PCNSL) of B-cell lineage, or secondary central nervous system lymphoma (SCNSL) with a previously confirmed B-cell origin primary lesion but without evidence of active extracranial systemic involvement.\n2. The patients or their legal guardians provide voluntary written informed consent.\n3. Age\\>=18 years, both male and female.\n4. Karnofsky Performance Status (KPS) score\\>=40.\n5. Patients deemed unsuitable for methotrexate (MTX)-based systemic chemotherapy (\"unfit\"), including but not limited to: patients assessed as unsuitable for chemotherapy or frail according to a simplified Geriatric Assessment (sGA) criteria; patients with contraindications to MTX (e.g., renal insufficiency, serous cavity effusions, oral mucositis, etc.); or patients who refuse high-dose methotrexate (HD-MTX) chemotherapy.\n6. Life expectancy of greater than 3 months, as judged by the investigator.\n7. Patients with parenchymal lesions (\\>10\\*10mm ) on contrast-enhanced cranial MRI or those with leptomeningeal disease only, require cytological examination of cerebrospinal fluid (CSF) to confirm the presence of lymphoma cells and\u002For imaging findings consistent with CSF results. These assessments must be completed within 14 days prior to enrollment.\n8. If the patients have received prior anti-tumor therapy, all treatment-related non-hematologic toxicities must have recovered to Grade 1 or baseline (according to NCI CTCAE version 5.0, with the exception of alopecia).\n9. Bone marrow and organ function must meet the following criteria (without transfusion, G-CSF support, or corrective therapy within 14 days prior to informed consent):\n\n   1. Hematological: Absolute neutrophil count (ANC) \\>=1.5\\*10\\^9\u002FL (1500\u002Fmm\\^3), platelets \\>=75\\*10\\^9\u002FL, hemoglobin\\>=8 g\u002FdL (If bone marrow is involved, then platelets\\>=50\\*10\\^9\u002FL, ANC \\>=1.0\\*10\\^9\u002FL, and hemoglobin\\>=7 g\u002FdL are acceptable).\n   2. Hepatic: Total bilirubin \\\u003C=1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=2.5 × ULN.\n   3. Renal: Serum creatinine \\\u003C=1.5 × ULN or estimated creatinine clearance \\>=60 mL\u002Fmin.\n   4. Coagulation: INR \\\u003C=1.5 × ULN; PT and APTT \\\u003C=1.5 × ULN (unless the subject is receiving anticoagulant therapy and, at screening, PT and APTT are within the anticipated therapeutic range for the anticoagulant regimen).\n10. For the subjects of reproductive age women and fertile men, during the entire study period and within 3 months after the interruption of treatment, they must not have any conception plans with their partners. During the entire study period and within 3 months after the interruption of treatment, one of the following measures must be taken for effective contraception: abstinence, physical contraception (such as sterilization or condoms), and the use of hormonal contraceptive drugs (w hich must start at least 3 months before the first administration upon enrollment). For male subjects, sperm donation is prohibited from the start of treatment until 3 months after the cessation of treatment.\n11. Willingness and ability to undergo multiple MRI\u002FCT scans and an expected ability to undergo lumbar puncture.\n\nAbility to swallow oral medication without difficulty.\n\nExclusion Criteria:\n\n1. The patients with secondary central nervous system lymphoma (SCNSL) who have lesions outside the CNS and require systemic treatment.\n2. Received chemotherapy, radiotherapy, immunotherapy or antibody-based treatments for anti-tumor purposes within 4 weeks prior to the first administration (or within 5 half-lives), those who had used small molecule targeted drugs or traditional Chinese medicine with anti-tumor indications within 2 weeks, and those who had received monoclonal antibody conjugate drug treatments within 10 weeks.\n3. Receipt of any vaccine (including but not limited to vaccines for COVID-19, influenza, pneumonia, shingles, hepatitis B, etc.) within 4 weeks before taking the medicine for the first time.\n4. Concurrent enrollment in another interventional clinical study, or less than 4 weeks between the last dose of prior clinical trial treatment and the first dose in this study.\n5. Previous treatment with thiotepa, PD-1 inhibitors, or BTK inhibitors is not excluded by default but requires benefit-risk assessment by the investigator. Subjects with a history of Grade \\>=3 immune-related adverse events (per NCI CTCAE v5.0) attributed to these agents are excluded.\n6. History of active bleeding within 4 weeks before the first dose; need for therapeutic anticoagulation during the study (e.g., warfarin or vitamin K antagonists); or any condition associated with elevated bleeding risk or coagulopathy per investigator judgment (e.g., high-risk esophageal varices, active ulcer disease).\n7. Treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers is required within 2 weeks before the first administration or during the study period.\n8. Concurrent presence of other malignant tumors requiring antineoplastic treatment.\n9. Having uncontrolled or significant cardiovascular diseases, including (but not limited to):\n\n   1. Any of the following conditions occurring within 6 months before the first administration: congestive heart failure with New York Heart Association class \\>= 3, myocardial infarction, unstable angina pectoris, arrhythmia requiring treatment at screening, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n   2. Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy);\n   3. A history of clinically significant QTc interval prolongation, second-degree type II atrioventricular block, third-degree atrioventricular block, or a QTc interval \\> 470ms (for females) and \\> 450ms (for males);\n   4. Atrial fibrillation (EHRA class\\>= 2b);\n   5. Poorly controlled hypertension, which is deemed unsuitable for study participation by the investigator.\n10. Active uncontrolled infection requiring intravenous antimicrobial treatment.\n11. Patients with active chronic hepatitis B, active chronic hepatitis C, or syphilis. Patients who test positive for hepatitis B surface antigen or hepatitis C virus antibody during the screening period must undergo further tests for HBV DNA titer (which must not exceed 1000 IU\u002Fml) and HCV RNA (which must not exceed the lower detection limit of the assay) before being eligible for enrollment in the trial. Hepatitis B virus carriers, patients with hepatitis B stabilized after drug treatment, and patients with cured hepatitis C may be enrolled.\n12. Patients with a known history of HIV infection and\u002For AIDS.\n13. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction), or total gastrectomy.\n14. Autologous transplantation within 3 months, or organ or allogeneic stem cell transplantation within 6 months, before signing the informed consent form.\n15. Pregnancy or lactation.\n16. Stroke or intracranial hemorrhage within 6 months before first dosing, excluding post-surgical sequelae of intracranial bleeding.\n17. History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or similar conditions, deemed by the researcher as rendering the subject unsuitable for participation in the trial.\n18. Participants whom the investigator considers unsuitable for the study due to existing kidney, nerve\u002Fmental, liver, or endocrine diseases, or for any other reason judged by the researcher.\n19. Exclude patients with active autoimmune disease or a history of it, including but not limited to: immune-related neurologic disorders, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barré syndrome, myasthenia gravis, SLE, connective-tissue disease, scleroderma, inflammatory bowel disease (Crohn's or ulcerative colitis), hepatitis, TEN, Stevens-Johnson syndrome, antiphospholipid syndrome.\n\n    Note: allow subjects with vitiligo, eczema, type 1 diabetes, or endocrine disorders (e.g., thyroiditis on physiologic steroid replacement). Subjects with rheumatoid arthritis\u002Fother arthropathies, Sjögren's syndrome, controlled celiac disease, or psoriasis treated only topically, and those seropositive (ANA, anti-thyroid antibodies, etc.) must be assessed for target-organ involvement and need for systemic therapy; if neither is present, they may be enrolled.\n20. Major surgery within 28 days prior to the first study dose, as determined by the investigator.",{"count":242,"type":20},24,[23],"This is a prospective, single-Arm, phase II clinical study evaluating the efficacy and safety of thiotepa in combination with pirtobrutinib (a BTK Inhibitor) and sintilimab (a PD-1 Inhibitor) for frail or relapsed\u002Frefractory primary or secondary central nervous system lymphoma.It includes screening phase， induction therapy phase, and maintenance therapy phase.The screening period is defined as within 14 days prior to the first dose.Induction Treatment Phase: Enrolled subjects will receive a combination regimen of thiotepa, pirtobrutinib, and sintilimab. Treatment is administered in 21-day cycles for up to 6 cycles. Patients who achieve a disease response may proceed to consolidation therapy with either autologous hematopoietic stem cell transplantation or whole-brain radiotherapy at the investigator's discretion.Maintenance Treatment Phase: For patients who do not receive consolidation therapy with autologous transplantation or whole-brain radiotherapy, maintenance treatment with pirtobrutinib plus sintilimab will be initiated (for up to 1 year). Patients who receive any consolidation therapy will not proceed to maintenance treatment.Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria. The trial will monitor patient survival data, objective response rate (ORR), and safety parameters.Upon discontinuation of study treatment or completion of the 1-year treatment period, subjects will enter the follow-up phase. During follow-up, radiographic assessments (contrast-enhanced CT of the involved site is recommended) will be performed according to the following schedule: every 3 months for the first 2 years, every 6 months from Year 3 to Year 5, and annually after 5 years, until the end of the follow-up period. For subjects who have not withdrawn consent, survival information (including date and cause of death, subsequent anti-tumor therapies, etc.) will be collected every 3 months via telephone and\u002For clinical visit.",[246,247,31],"Pirtobrutinib","Sintilimab",[249,250,251],"pirtobrutinib","sintilimab","central nervous system lymphoma","2026-02-11",{"date":254,"type":64},"2026-02-18",{"date":256,"type":20},"2026-02-10",{"date":258,"type":20},"2030-08-05",{"name":260,"class":96},"Zhejiang Cancer Hospital",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":151},"100624101","phase-2-zillion-zanubrutinib-combined-with-chemotherapy-for-newly-diagnosed-cns-lymphoma-100624101","NCT07405255","Zillion: Zanubrutinib Combined With Chemotherapy for Newly Diagnosed CNS Lymphoma","Clinical Study on the Efficacy and Safety of Zanubrutinib Combined With Chemotherapy for Continuous Maintenance Treatment of Newly Diagnosed Central Nervous System Lymphoma","Zillion","Inclusion Criteria:\n\n* Have a full understanding of this study and voluntarily sign the informed consent form.\n* Untreated patients with primary central nervous system lymphoma (PCNSL) confirmed by pathology (immunotyping) according to the 2016 WHO classification of lymphoid neoplasms.\n* Diffuse large B-cell lymphoma (DLBCL) originating from the central nervous system (CNS) without involvement of other organs, confirmed by PET-CT or contrast-enhanced CT.\n* Expected survival greater than 3 months.\n* Laboratory test results meeting all of the following:\n* Creatinine clearance rate ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n* International normalized ratio (INR) ≤ 1.5 × ULN or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. Patients on warfarin may have INR 2-3.\n* Left ventricular ejection fraction (LVEF) ≥ 50%.\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin.\n* Male or female patients of childbearing potential must agree to use effective contraception (e.g., double-barrier methods, condoms, oral or injectable contraceptives, intrauterine device) during the study and for 30 days after the last dose.\n* Postmenopausal women (\\> 45 years old and amenorrheic \\> 1 year) or surgically sterilized women are exempt from this requirement.\n\nExclusion Criteria:\n\n* Contraindication to any drug included in the treatment regimen.\n* History of clinically significant liver disease, including viral or other hepatitis or cirrhosis.\n* Hepatitis B: Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV-DNA above ULN.\n* Active hepatitis C: Positive HCV antibody with detectable HCV-RNA.\n* Human Immunodeficiency Virus (HIV) infection.\n* Congestive heart failure (New York Heart Association Class \\> II) or history within 6 months of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack.\n* Hereditary long QT syndrome or QTc \\> 480 ms (QTc calculated using Fridericia's formula, QTcF = QT \u002F RR\\^0.33).\n* Other malignancies within 5 years, except: completely cured cervical carcinoma in situ, basal cell carcinoma of the skin, breast carcinoma in situ, or another primary cancer that has been cured and not recurred within 5 years.\n* Pregnant or lactating women, or women planning pregnancy during the study period.\n* History of significant neurological or psychiatric disorders, including substance or psychotropic-drug abuse.\n* Clinically significant active infection.\n* Inability to take or swallow oral medication, or conditions affecting drug absorption (e.g., chronic diarrhea, intestinal obstruction).",{"count":270,"type":20},19,[23],"Subjects who met the inclusion\u002Fexclusion criteria were included in the experimental group after signing the informed consent form. One course of Z(R)-MTX(TMZ) treatment was given. After the results of the second-generation sequencing were reported, selinisol was added to the original treatment plan for those with TP53 mutations, and the original treatment plan was continued for those without TP53 mutations. Each course of treatment lasts for three weeks. A mid-term assessment is conducted after three courses of treatment, and a final assessment is carried out after six courses of treatment. After the mid-term or final assessment:\n\nIf the PR is not achieved or the disease progresses at any time, the subjects are withdrawn from the group and receive salvage treatment.\n\nIf the subjects achieve CR or PR, they enter maintenance treatment and continue with zanubrutinib for 2 years. For young patients (\\\u003C 65 years old), they can choose whether to receive ASCT as consolidation treatment according to their personal will, and then follow up and observe until 3 years have passed.\n\nSD\u002FPD patients receive subsequent treatment after being judged by the researchers",[31],{"date":275,"type":64},"2026-02-12",{"date":277,"type":20},"2026-01-30",{"date":279,"type":20},"2028-12-30",{"name":281,"class":96},"Ruijin Hospital",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":209,"enrollmentInfo":288,"targetDuration":4,"studyType":188,"phases":4,"briefSummary":290,"conditions":291,"keywords":298,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":151},"100314599","long-term-follow-up-study-of-patients-receiving-car-t-cells-100314599","NCT03375619","Long-term Follow-up Study of Patients Receiving CAR-T Cells","Inclusion Criteria:\n\n* All participants who enrolled in a CAR-T study at Froedtert Hospital \\& the Medical College of Wisconsin.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study.",{"count":289,"type":20},500,"This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin\u002F Froedtert Hospital. The clinical trials include the following:\n\nPhase 1 Study of CAR-20\u002F19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)",[292,293,294,295,31,218,216,296,297],"Chronic Lymphocytic Leukemia","Lymphomas Non-Hodgkin's B-Cell","Lymphoma, Small Lymphocytic","Mantle Cell Lymphoma","Burkitt Lymphoma","Multiple Myeloma",[299,300],"CAR-T Cell Therapy","chimeric antigen receptor","2025-11-06",{"date":303,"type":64},"2025-11-10",{"date":305,"type":64},"2017-12-01",{"date":307,"type":20},"2035-01-01",{"name":233,"class":96},{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":21,"phases":319,"briefSummary":320,"conditions":321,"keywords":322,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100492899","phase-1-selinexor-in-combination-with-mtxritu-to-treat-rr-cnsl-100492899","NCT05698147","Selinexor in Combination With MTX+Ritu to Treat R\u002FR CNSL","Selinexor in Combination With Methotrexate and Rituximab for Relapsed \u002FRefractory Central Nervous System (CNS) Lymphoma","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:\n\n  1. Participants must be able to understand and be willing to sign a written informed consent document.\n  2. Men and woman who are 18-75 years old on the day of consenting to the study.\n  3. Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL).\n  4. Patients must have relapsed\u002Frefractory PCNSL or relapsed\u002Frefractory SCNSL.\n  5. Patients must have response or remain stable disease for 2 months to prior methotrexate-based regimen.\n  6. Patients who had prior autologous hematopoietic stem cell transplantation are eligible.\n  7. Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 28 days prior to cycle1 day 1(C1D1). For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells.\n  8. Participants must have an Eastern Cooperative Oncology Group performance status of 0-3.\n  9. Participants must have adequate bone marrow and organ function shown by:\n\n     1. Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL\n     2. Platelets ≥ 75 x 10\\^9\u002FL and no platelet transfusion within the past 14 days prior to study registration c Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 14 days prior to study registration\n  10. International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal.\n  11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal.\n  12. Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.\n  13. Calculated creatinine clearance(CrCl)≥50ml\u002Fmin using the Cockcroft-Gault equation or 24-hour urine collection.\n  14. Life expectancy of \\> 3 months.\n\nExclusion Criteria:\n\n1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.\n2. Lymphoma patients with only intraocular involvement.\n3. Pathological diagnosis of PCNSL is T-cell lymphoma.\n4. Patients with disease progression within 6 months of prior methotrexate-containing regimen.\n5. patients only had received stereotactic radiation therapy as prior treatment.\n6. Patients have received chemotherapy, monoclonal antibodies or targeted anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior to C1D1.\n7. Patients with active, unstable cardiovascular diseases, fits any of the following:\n\n   1. myocardial infarction within 6 months prior to the study enrollment\n   2. unstable angina within 3 months prior to the study enrollment\n   3. Uncontrolled clinically-significant conduction abnormalities (e.g., ventricular tachycardia, ventricular fibrillation, etc.)\n   4. Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3\n   5. Echocardiography showing left ventricular ejection fraction less than 50%\n8. Uncontrolled active infection within 1 week prior to the first dose of study drug.\n9. Known active hepatitis B, or C infection or HIV infection; Note: Hepatitis B virus (HBV) surface antigen (HBsAg) and or hepatitis B core antibody-positive but undetectable HBV DNA or Hepatitis C virus (HCV) antibody positive but hepatitis C virus RNA undetectable are allowed.\n10. Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment.\n11. Prior exposure to a selective inhibitor of nuclear export(SINE) compound, including selinexor.\n12. Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.","75 Years",{"count":318,"type":20},30,[84,23],"This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.",[31],[323,324,325,326,327],"Relapse refractory","Selinexor","ATG-010","Primary Central Nervous System Lymphoma（PCNSL）","Secondary Central Nervous System Lymphoma（SCNSL）","2025-09-13",{"date":330,"type":64},"2025-09-16",{"date":332,"type":64},"2023-08-03",{"date":334,"type":20},"2026-12-31",{"name":336,"class":96},"Tong Chen, MD",5,{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":346,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":357,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":151},"100532502","phase-1-fourth-gen-car-t-cells-targeting-cd19cd22-for-highly-resistant-b-cell-lymphomaleukemia-pmbclcns-bcl-100532502","NCT06213636","Fourth-gen CAR T Cells Targeting CD19\u002FCD22 for Highly Resistant B-cell Lymphoma\u002FLeukemia (PMBCL\u002FCNS-BCL).","T-cell Infusion Targeting CD19 and CD22 for Refractory\u002FRelapsed Leukemia\u002FLymphoma Patients With or Without Central Nervous System Involvement","BAH241","Inclusion Criteria:\n\n* Diagnosis: ALL In view of the PI and the primary oncologist, there must be no available alternative curative therapies or subject has declined to pursue alternative therapy; and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment.\n* Chemotherapy refractory disease in subjects with B-ALL is defined as progression or stable disease after two lines of therapies\n* Recurrence of disease after achieving a complete response (CR).\n* Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD positivity on two occasions at least 4 weeks apart.\n* Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).\n* Subjects with recurrence of isolated CNS relapse after achieving complete remission (CR); if relapsed with MRD, will require verification of MRD positivity on two occasions at least 4 weeks apart.\n* Diagnosis: Lymphoma Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody. Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.\n* CD19 expression CD19 expression is required at any time since diagnosis. If patient has received anti-CD19 targeted therapy (i.e. Blinatumomab), then CD19 expression must be subsequently demonstrated. CD19 expression. must be detected on greater than 50% of the malignant cells by immunohistochemistry or ≥ 90% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples.\n* Subjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other eligibility criteria are met. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post-transplant, they have no evidence of active GVHD and have been without immunosuppressive agents for at least 30 days.\n* Subjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if \\\u003C 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometry.\n* Must have evaluable or measurable disease; subjects with lymphoma must have evaluable or measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma\\[66\\] must be present. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives.\n* Exceptions:\n* There is no time restriction with regard to prior intrathecal chemotherapy (incl. steroids) provided there is complete recovery from any acute toxic effects of such; g. Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; h. Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis.\n* Subjects receiving steroid therapy at physiologic replacement doses (≤ 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; j. For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable\u002Fevaluable disease outside the radiation port.\n* Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator's ability to assess treatment emergent toxicities)\n* Age Greater than or equal to 1 year of age and less than or equal to 30 years of age at time of enrollment; must meet parameters for apheresis per institutional guidelines. NOTE: The first subject in the first dose cohort must be ≥ 18 years of age if an adult has not been treated at that dose cohort on the companion Stanford protocol \"Phase 1 Dose Escalation Study of CD19\u002FCD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies\" and undergone safety evaluation at Day 28 without evidence of DLT.\n* Performance Status: Subjects \\> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50% (See Appendix B Section 14.2)\n* Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion)\n* ANC ≥750\u002FuL\\*\n* Platelet count ≥50,000\u002FuL\\*\n* Absolute lymphocyte count ≥150\u002FuL\\*\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n* Serum ALT\u002FAST ≤10 ULN (unless elevated ALT\u002FAST is attributed to leukemia or lymphoma involvement of the liver, in which case this criterion will be waived and not disqualify a patient).\n* Total bilirubin ≤1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n* Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n* No clinically significant pleural effusion\n* Baseline oxygen saturation \\>92% on room air at rest\n* creatinine: within age adjusted normal institutional limits (see table below) OR\n* creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 (as estimated by Cockcroft Gault Equation) for subjects with creatinine levels above institutional normal.\n* Age (Years) Maximum Serum Creatinine (mg\u002FdL)\n\n  -≤5 0.8 5 \\\u003C age ≤ 10 1.0 \\>10 1.2\n* if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies.\n* CNS Status\n* Subjects with ALL\n* Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:\n* CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs;\n* CNS 2, defined as presence of \\\u003C 5\u002FµL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FµL WBCs but negative by Steinherz\u002FBleyer algorithm:\n\nCNS 2a: \\\u003C10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts; CNS 2b: ≥10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts; CNS 2c: ≥10\u002FµL RBCs; ≥5\u002FµL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n\n* Subjects with lymphoma\n* Subjects must have no signs or symptoms of CNS disease or detectable evidence of CNS disease on MRI at the time of screening. Subjects who have previously been treated for CNS disease and who have the following CNS status will be eligible:\n* CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs;\n* CNS 2, defined as presence of \\\u003C 5\u002FµL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FµL WBCs but negative by Steinherz\u002FBleyer algorithm:\n* CNS 2a: \\\u003C 10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts;\n* CNS 2b: ≥ 10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts;\n* CNS 2c: ≥ 10\u002FµL RBCs; ≥ 5\u002FµL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n* 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 2 years are not considered to be of childbearing potential)\n* Contraception Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen.\n* Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous\u002Funknown effects on the fetus.\n* Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent. For subjects \\\u003C18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those \\> 7 years of age, when appropriate.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible for participation in the study:\n\n* Recurrent or refractory ALL limited to isolated testicular.\n* Subjects with radiologically-detected CNS lymphoma or CNS 3 disease (presence of ≥ 5\u002FµL WBCs in CSF and cytospin positive for blasts \\[in the absence of a traumatic lumbar puncture\\] and\u002For clinical signs of CNS leukemia).\n* Hyperleukocytosis (≥ 50,000 blasts\u002FµL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n* History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years.\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n* Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* CNS disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in the judgment of the investigator may impair the ability to evaluate neurotoxicity.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement.\n* Subjects receiving anticoagulation therapy.\n* Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning lymphodepletion chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* May not have primary immunodeficiency or history of systemic autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.","2 Years","90 Years",{"count":349,"type":20},75,[84,23],"This is an open-label, single-arm, phase I clinical trial with dose escalation designed to investigate the safety, tolerability, and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion. The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II.\n\nEligible participants, including those with Central Nervous System Lymphoma, B Cell Lymphoma (BCL), Acute Lymphocytic Leukemia (ALL), Acute Lymphoblastic Leukemia (ALL), B Acute Lymphoblastic Leukemia (B-ALL), Refractory Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia (CLL), Refractory B Acute Lymphoblastic Leukemia (B-ALL), Diffuse Large B Cell Lymphoma, Lymphoid Leukemia, and MRD-positive cases, can participate. Eligibility will be determined through a comprehensive assessment, including disease evaluations, a physical examination, Electrocardiograph, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and blood tests. Prior to the infusion of CD19-CD22 CAR+ T cells, participants will undergo chemotherapy. After the infusion, participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR+ T cells. Certain study procedures may be conducted during hospitalization.",[353,354,355,218,31,356,53],"Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, in Relapse","Non-Hodgkin Lymphoma, B-cell","Lymphoma, Follicular",[31,358,359,360,218,361],"B Cell Lymphoma (BCL)","Acute Lymphocytic Leukemia (ALL)","Refractory Non-Hodgkin Lymphoma","MRD-positive cases","2025-08-05",{"date":364,"type":64},"2025-08-06",{"date":366,"type":64},"2024-07-10",{"date":368,"type":20},"2028-12-10",{"name":370,"class":96},"Essen Biotech",{"id":372,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":384,"leadSponsor":385,"locationsCount":386},"100423333","Inclusion Criteria:\n\n* Histologically confirmed B-cell non-Hodgkin's lymphoma:\n* DLBCL DLBCL or associated subtype, defined by WHO 2016 classification:\n* DLBCL not otherwise specified (NOS)\n* High-grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements\n* High-grade B cell lymphoma (NOS)\n* Primary mediastinal (thymic) large B cell lymphoma\n* Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)\n* CNS Cohort only: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)\n* Mantle Cell Lymphoma (MCL) Cohort: Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation\n* Richter's Transformation (RT) Cohort: Histologically confirmed Richter's transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)\n* Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either having failed autologous stem cell transplant (ASCT), or ineligible, not intended for or not consenting to ASCT\n* Chemotherapy-refractory disease is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma\n* Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen\n* CNS Cohort: Subjects with relapsed\u002Frefractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.\n* No contraindications for MRI evaluation\n* CNS Cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy\n* Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and\u002For with or without an autologous stem cell transplant\n* No contraindications for MRI evaluation\n* MCL Cohort: Subjects with relapsed\u002Frefractory disease after at least one prior systemic treatment, that must include:\n* Cytotoxic rituximab-based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND\n* BTK inhibitor\n* RT Cohort: Subject must have relapsed\u002Frefractory disease after at least one prior systemic treatment following Richter's Transformation\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to lymphoma\n* Measurable disease according to Lugano 2014 criteria for assessing FDG-PET\u002FCT in systemic lymphoma (Cheson et al, 2014). Measurable disease according to IPCG criteria will be assessed by brain\u002Fspine MRI for CNS disease\n* Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion. If medically not feasible to obtain a biopsy from the most recent relapse and for cases when the amount of tissue is limited, the sponsor should be consulted, to confirm adequacy of the sample for study required analyses\n* No clinical suspicion of central nervous system (CNS) lymphoma (not applicable to CNS cohort)\n* If the subject has history of CNS disease (not applicable to CNS cohort), then he\u002Fshe must have no signs or symptoms of CNS disease, have no active disease on magnetic resonance imaging (MRI), have no large cell lymphoma present in cerebral spinal fluid (CSF), regardless of the number of white blood cells (WBCs)\n* If has history of cerebral vascular accident (CVA), the CVA event must be greater than 12 months prior to leukapheresis. Any neurological deficits must be stable\n* A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) \\> 45mL\u002Fmin\n* Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)\n* Resting O2 saturation \\>90% on room air\n* Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST)\\\u003C5 times the Upper Limit of Normal (ULN) for age\n* Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n* Absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Absolute lymphocyte count \\> 100\u002FμL\n* Platelet count \\> 50,000\u002FµL\n* Estimated life expectancy of more than 3 months other than primary disease\n\nExclusion Criteria:\n\n* Primary CNS lymphoma (not applicable to CNS cohort)\n* Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL) (not applicable to RT cohort)\n* Unable to give informed consent\n* Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be quantitative polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive\n* Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* Pharmacologically uncontrolled seizures.\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory disease\n* Presence of CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity. For CNS Cohort:\n* Midline shift on MRI\n* Abnormal high CSF opening pressure and or CSF protein \\>150 mg\u002FdL Recent (within 3 months) whole brain radiotherapy (WBRT)\n* Active systemic fungal, viral, or bacterial infection\n* Pregnant or breast-feeding woman\n* Previous or concurrent malignancy with the following exceptions:\n* Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to study entry)\n* In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study\n* Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years\n* A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n* Severely immunocompromised subjects e.g., due to current treatment of non-neurologic autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).\n* Medical condition requiring prolonged use of systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday. For CNS cohort: Up to 2 mg\u002Fday dexamethasone (or equivalence) may be allowed at any time, higher doses allowed up to 7 days prior to apheresis or after apheresis until lymphodepletion.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n* Concurrent radiotherapy (normal tissue sparing palliative radiotherapy allowed up to time of lymphodepletion). For systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.\n* Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study\n* Refusal to participate in additional lentiviral gene therapy LTFU protocol\n* Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma\n* Prior allogeneic stem cell transplant for any indication\n* Prior BITE antibodies for cancer therapy\n* Prior T cell receptor-engineered T cell therapy",{"count":375,"type":20},248,[23],"DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.",[26,27,28,29,30,31,32,33],[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"2025-04-21",{"date":382,"type":64},"2025-04-24",{"date":66,"type":64},{"date":68,"type":20},{"name":70,"class":71},25,{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":316,"enrollmentInfo":394,"targetDuration":4,"studyType":21,"phases":395,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":151},"100455366","phase-2-orelabrutinib-combined-with-pemetrexed-for-relapsedrefractory-central-nervous-system-lymphoma-100455366","NCT05209620","Orelabrutinib Combined With Pemetrexed For Relapsed\u002FRefractory Central Nervous System Lymphoma","A Single Arm, Phase II Clinical Trial of Orelabrutinib Combined With Pemetrexed in the Treatment for Patients With Relapsed\u002FRefractory Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Age between 18 to 75 years old (including 18 and 75)\n2. Diagnosed as diffuse large B-cell lymphoma; Recurrence or progression of central nervous system disease confirmed by imaging ± tissue biopsy pathology or cerebrospinal fluid flow cytometry; Secondary central nervous system lymphoma can also be admitted when the systemic disease is well controlled\n3. Having at least one measurable lesions\n4. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 ( ECOG 3 due to tumors can be included after being fully assessed by the investigator)\n5. Life expectancy no less than 1 month\n6. enough main organ function\n7. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study\n8. Agreeing to sign the written informed consents\n\nExclusion Criteria:\n\n1. Poor peripheral disease control of secondary central nervous system lymphoma\n2. Patients used pemetrexed or orelabrutinib in the past\n3. Active malignant tumor need be treated at the same time\n4. Other malignant tumor history\n5. Serious surgery and trauma less than two weeks\n6. Patients with active tuberculosis\n7. Systemic therapy for serious acute\u002Fchronic infection\n8. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months\n9. HIV-positive, AIDS patients and untreated active hepatitis\n10. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months\n11. Patients with a history of mental illness or drug abuse\n12. Poor compliance during the trial and\u002For follow-up phase\n13. Allergies or people who are known to be allergic to any active ingredients, excipients, mouse-derived products or heterologous protein contained in this trial\n14. Researchers determine unsuited to participate in this trial",{"count":318,"type":20},[23],"This is a prospective single arm, phase II clinical trial to observe the efficacy and safety of orelabrutinib combined with pemetrexed in the treatment for patients with relapsed\u002Frefractory central nervous system lymphoma.",[31],[31,399,400],"BTK inhibitor","Relapsed and Refractory","2025-04-18",{"date":403,"type":64},"2025-04-23",{"date":405,"type":64},"2021-12-21",{"date":407,"type":20},"2026-12-21",{"name":409,"class":410},"Henan Cancer Hospital","OTHER_GOV",{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":418,"targetDuration":420,"studyType":188,"phases":4,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":151},"100448044","secondary-central-nervous-system-lymphoma-registry---charit-100448044","NCT05114330","Secondary Central Nervous System Lymphoma Registry - Charité","Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice","Inclusion Criteria:\n\n• All patients with SCNSL can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for SCNSL.\n\nExclusion Criteria:\n\n• None",{"count":419,"type":20},300,"3 Years","The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. In particular, the following questions will be specified:\n\n* What therapeutic approaches are being pursued?\n* What is the clinical outcome of the various treatment options?\n* What is the frequency of serious adverse events with each therapeutic approach?",[31,423],"Non-Hodgkin Lymphoma","2023-11-23",{"date":426,"type":64},"2023-11-27",{"date":428,"type":64},"2011-06-08",{"date":430,"type":20},"2026-06-08",{"name":432,"class":96},"Charite University, Berlin, Germany",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":441,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":21,"phases":444,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":151},"100459284","phase-2-lenalidomide-maintenance-treatment-in-patients-with-primary-central-nervous-system-lymphoma-100459284","NCT05260619","Lenalidomide Maintenance Treatment in Patients With Primary Central Nervous System Lymphoma","Phase II Trial of Lenalidomide Maintenance After High-dose Methotrexate-based Immunochemotherapy in Patients With Primary Central Nervous System Lymphoma","PCNSL-LEM","Inclusion Criteria:\n\n1. PCNSL patients whose achieved response (CR\u002FPR) after first line immunochemotherapy treatment\n2. histology confirmed to be PCNSL\n3. ECOG \\\u003C 3\n4. Hematology values must be within the following limits:\n\n   Absolute neutrophil count (ANC) ≥ 1000\u002Fµl Platelets ≥75,000\u002Fµl\n5. Biochemical values within the following limits:\n\n   Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) Total bilirubin ≤ 2.0 x ULN Creatinine clearance (CrCl) of greater than or equal to 30 mL\u002Fmin.\n6. Females of childbearing potential\\* must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU\u002FmL within 10 - 14 days and again within24 hours prior to prescribing lenalidomide for Cycle 1 and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide.\n\n   \\*A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months).\n7. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy.\n8. Patient must understand and voluntarily sign an informed consent form, with the understanding that the patient may withdraw consent at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females.\n2. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.\n3. Known history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection requiring intravenous (IV) antibiotics.\n4. Patients with extra-central nervous system lymphoma\n5. Patients who were previously exposed and who developed adverse events, hypersensitivity or desquamating rash to lenalidomide\n6. prior cancer history","19 Years",{"count":443,"type":20},28,[23],"The study will include 28 patients with primary CNS DLBCL who are ineligible with autologous hematopoietic stem cell transplantation or whole brain radiation therapy as consolidation therapy.\n\nInduction treatment will include Rituximab and high dose methotrexate protocol (containing at least methotrexate and one more chemotherapy agent).\n\nPatients with MRI documented response CR or PR after induction chemotherapy will enter the study protocol of lenalidomide maintenance (at a dose of 15 mg per day, on days 1 to 21 of each 28-day cycle) for a maximum of 12 cycles, withdrew consent, the disease progressed, or unacceptable toxic effects occurred.",[31],"2022-02-18",{"date":449,"type":64},"2022-03-02",{"date":451,"type":20},"2022-04-01",{"date":453,"type":20},"2028-04-01",{"name":455,"class":96},"Seoul National University Bundang Hospital"]