[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"secondary-central-nervous-system-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:secondary-central-nervous-system-lymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,54,78,103,130,153,174],{"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":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":53},"100599313","phase-1-a-study-of-epcoritamab-and-ibrutinib-in-people-with-central-nervous-system-lymphoma-cnsl-100599313",false,"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.","ALL","18 Years",{"count":19,"type":20},26,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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).",[26,27,28,29,30,31,32],"Primary Central Nervous System Lymphoma (PCNSL)","Primary Central Nervous System Lymphoma","Relapsed Primary Central Nervous System Lymphoma","Refractory Primary Central Nervous System Lymphoma","Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma (SCNSL)",[27,34,35,36,30,31,37,38,39,40,41],"PCNSL","Relapsed Primary Central Nervous Lymphoma","Refractory Primary Central Nervous Lymphoma","SCNSL","epcoritamab","ibrutinib","25-032","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-06-10",{"date":45,"type":46},"2026-06-11","ACTUAL",{"date":48,"type":46},"2025-08-13",{"date":50,"type":20},"2028-08",{"name":41,"class":52},"OTHER",8,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":5},"100603513","phase-1-a-study-of-mb-cart191-cellular-therapy-for-people-with-central-nervous-system-lymphoma-cnsl-100603513","NCT07137494","A Study of MB-CART19.1 Cellular Therapy for People With Central Nervous System Lymphoma (CNSL)","A Phase I Study of MB-CART19.1 Cellular Therapy for Relapsed\u002FRefractory Primary and Secondary Central Nervous System Lymphoma (CNSL) Using On- Site Manufacturing With the CliniMACS Prodigy Device","Inclusion Criteria:\n\n* Men and women who are at least 18 years of age on the day of consenting to the study.\n* Histologically documented primary or secondary central nervous system lymphoma of DLBCL subtype\n* Relapsed\u002Frefractory primary or secondary CNSL patients. All relapsed\u002F\u002Frefractory patients need to have received at least one prior CNS-directed methotrexate-based therapy. There is no restriction on the number of recurrences.\n* For relapsed patients, parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) within 21 days of study consent.\n* For refractory patients, there must be residual disease after their last line of therapy.\n* For patients with leptomeningeal disease only, CSF cytology and\u002For flow cytometry must document CSF findings consistent with CSF involvement by lymphoma and\u002For imaging findings consistent with CSF disease within 21 days of study registration (at the discretion of the investigator).\n* Creatinine Clearance ≥ 40 ml\u002Fmin\u002Fm2, direct bilirubin ≤2.0 mg\u002F100 ml, AST and ALT ≤3.0x upper limit of normal (ULN)\n* Adequate pulmonary function as assessed by ≥90% oxygen saturation on room air by pulse oximetry.\n* Must be able to tolerate both MRI and CT scans\n* Must be able to tolerate lumbar puncture and\u002For Ommaya taps\n* Must have been either off corticosteroids, or on a stable or decreasing dose of dexamethasone equivalent ≤ 2 mg daily for 7 days before apheresis and 72 hours prior to CAR T cell infusion o Use of corticosteroids to treat CAR T cell toxicities per MSKCC guidelines is permitted\n\nExclusion Criteria:\n\n* ECOG performance status \\>2\n\n  o Patients with ECOG status of 2 will be enrolled at the discretion of the PI\n* Active systemic lymphoma (i.e. involvement outside of the CNS)\n* If the most recent CSF or brain tissue sample demonstrates absence of CD19 expression\n* Size of any single CNS lymphoma lesion exceeds 3 cm in maximal diameter in eloquent brain structures.\n* Prior treatment of systemic lymphoma with CD19-targeted CAR T cells\n* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.\n* Impaired cardiac function (LVEF \\\u003C40%) as assessed by most recent ECHO in the last 1 year.\n* Patients with autoimmune disease requiring systemic T cell-suppressive therapy.\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration ≤6 months prior to enrollment\n* Patients with ocular lymphoma in the absence of other CNS involvement\n* Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C, or 3 months since allogeneic hematopoietic stem cell transplantation, prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.\n* Patients with HIV\n* Patients with active hepatitis B or hepatitis C infection (as manifested by either detectable hepatitis B virus DNA by PCR, hepatitis virus C RNA by PCR, or positivity for hepatitis B surface or core antigen)\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion\n* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin\n* Patients exposed to immune checkpoint inhibitor within 8 weeks\n* Use of herbal supplements are not allowed on study\n* Any other issue which, in the opinion of the treating physician or PI, would make the patient ineligible for the study.",{"count":62,"type":20},12,[23],"This study will test whether MB-CART19.1 is a safe and effective treatment for central nervous system lymphoma (CNSL). This study will test different doses of MB-CART19.1 to find the highest dose that causes few or mild side effects in participants.",[66,31],"Primary Central Nervous System (CNS) Lymphoma",[68,69,70],"MB-CART19.1 Cellular Therapy","Relapsed\u002FRefractory","CliniMACS Prodigy Device","2026-06-04",{"date":73,"type":46},"2026-06-05",{"date":75,"type":46},"2025-08-14",{"date":50,"type":20},{"name":41,"class":52},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"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":85,"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.",[30,89,90,91,92,31],"Hematopoietic and Lymphoid Cell Neoplasm","Leukemia","Lymphoma","Plasma Cell Myeloma","2026-05-18",{"date":95,"type":46},"2026-05-20",{"date":97,"type":46},"2020-01-09",{"date":99,"type":20},"2026-10-31",{"name":101,"class":52},"M.D. Anderson Cancer Center",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100458978","phase-1-acalabrutinib-maintenance-for-the-treatment-of-patients-with-large-b-cell-lymphoma-100458978","NCT05256641","Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma","Acalabrutinib Maintenance Following Cellular Therapy for Large B-Cell Lymphoma Patients at Very High Risk for Relapse","Inclusion Criteria:\n\n* Ages 18-70 years\n* One of the following:\n\n  * Patients undergoing autologous stem cell transplantation (ASCT) or any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy product for:\n\n    * High grade B-cell lymphoma (double or triple hit) with rearrangements in bcl-2 and\u002For bcl-6, and rearrangement in myc\n    * Large B-cell lymphoma with a history of secondary CNS involvement\n    * Histologic transformation of indolent lymphoma to large B-cell lymphoma, including marginal zone lymphoma, follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), lymphoplasmacytic leukemia, or Waldenstrom macroglobulinemia\n    * High risk international prognostic index (IPI) score 4 or 5, at diagnosis or prior to CAR T-cell leukapheresis\n  * Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Requirements for post-ASCT and post-alloHCT participants:\n\n  * Disease status of partial response (PR) or complete response (CR) prior to transplantation\n  * Receive reduced-intensity conditioning regimen\n  * Enrollment no later than day +90\n* Requirements for post-CAR T-cell therapy participants:\n\n  * Disease status of PR or CR after post-CAR T-cell therapy positron emission tomography (PET)-computed tomography (CT) at 1-3 months\n  * Enrollment no later than day +104\n* Ability to give full informed consent\n* Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib\n* Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty\n* Absolute neutrophil count (ANC) \\> 500\u002FuL (microliters)\n* Platelets \\> 50,000\u002FuL independent of transfusions\n* Hemoglobin \\> 8 g\u002FdL independent of transfusions\n* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x upper limit of normal (ULN)\n* Total bilirubin =\\\u003C 1.5 x ULN, unless directly attributable to Gilbert's syndrome\n* Creatinine clearance \\>= 60 mL\u002Fmin based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) =\\\u003C 1.8 mg\u002FdL\n\nExclusion Criteria:\n\n* Cord blood as donor source in alloHCT\n* New York Heart Association Class III or IV\n* Left ventricular ejection fraction \\\u003C 50%\n* Estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Concurrent long-term use of posaconazole or other strong CYP3A4 inhibitors and unable to replace with equivalent medication\n* Acute or chronic graft-versus-host disease (GvHD) \\>= stage 3 at time of enrollment\n* Received packed red blood cells (pRBC) transfusion within the past 2 weeks\n* Received platelet transfusion within the past 1 week\n* Active invasive fungal infection\n* Active bacterial or viral infection until resolution of the infection\n* History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)\n* Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug\n* Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n* Refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment\n* Received a live virus vaccination within 28 days of first dose of study drug\n* Known history of infection with human immunodeficiency virus (HIV)\n* History of bleeding diathesis (e.g., hemophilia, von Willebrand disease)\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited\n* Breastfeeding or pregnant\n* Concurrent participation in another therapeutic clinical trial","70 Years",{"count":112,"type":20},24,[23,114],"PHASE2","This phase Ib\u002FII trial studies the side effects and efficacy of maintenance acalabrutinib following cellular therapy in treating patients with large B-cell lymphoma at very high risk of the cancer coming back. Acalabrutinib is a small molecular inhibitor that may interfere with the ability of cancer cells to grow and spread.",[117,118,119,31],"Diffuse Large B-Cell Lymphoma","High-grade B-cell Lymphoma","Transformed Lymphoma","2026-03-06",{"date":122,"type":46},"2026-03-10",{"date":124,"type":46},"2023-01-23",{"date":126,"type":20},"2028-01-31",{"name":128,"class":52},"Jonsson Comprehensive Cancer Center",3,{"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":42,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":102},"100491597","phase-2-zanubrutinib-with-pemetrexed-to-treat-relapsedrefractory-primary-and-secondary-central-nervous-system-cns-lymphomas-100491597","NCT05681195","Zanubrutinib With Pemetrexed to Treat Relapsed\u002FRefractory Primary and Secondary Central Nervous System (CNS) Lymphomas","Zanubrutinib With Pemetrexed for the Treatment of Relapsed\u002FRefractory Primary and Secondary CNS Lymphomas: A Phase II Trial With a Safety Lead-In","Inclusion Criteria:\n\n1. Any of the following diseases histologically confirmed:\n\n   1. Primary CNS lymphoma or isolated secondary CNS involvement by diffuse large B cell lymphoma with measurable disease\n   2. Cytologic diagnosis of B cell non-Hodgkin's lymphoma with measurable disease\n   3. Ocular lymphoma with histologic confirmation of ocular lymphoma and measurable intracranial tumor. Slit-lamp examination and vitreal or retinal biopsy will be done to confirm ocular lymphoma.\n2. Karnofsky performance status (KPS) ≥ 30% (≥ 50% for patients ≥ 60 years-old)\n3. Progressed during first-line chemotherapy and\u002For radiotherapy -OR- insufficient clinical response to previous therapy or relapsed after initial successful treatment OR unable to tolerate previous therapy defined as Grade 3+ acute kidney injury (AKI) and\u002For transaminase elevation according to CTCAE v 5.0 criteria preventing repeat treatment exposure OR prior glucarpidase use due to high dose methotrexate delayed clearance and\u002For toxicity OR those who would have been glucarpidase candidates due to delayed methotrexate clearance (plasma methotrexate concentrations greater than 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered or toxic plasma methotrexate concentrations (\\>1 micromole per liter) in patients with delayed methotrexate clearance) due to impaired renal function OR unable to receive high dose methotrexate induction on every 2 week +\u002F- 3 days schedule due to deconditioning and\u002FOR need for physical rehabilitation between the high dose methotrexate treatments\n4. No systemic lymphoma by positron emission tomography (PET) CT or CT scan of the chest, abdomen, and pelvis with contrast\n5. Adequate bone marrow and organ function demonstrated by:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   2. Platelets ≥ 75 x 10\\^9\u002FL and no platelet transfusion within the past 14 days prior to study enrollment\n   3. Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 14 days prior to study enrollment\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal\n   5. 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   6. Creatinine Clearance (CrCl)\\> 45 mL\u002Fminute using Cockcroft-Gault formula\n6. Ability to understand and sign written informed consent prior to study entry unless the subject suffers from cognitive or physical impairment due to their CNS malignancy or due to a known underlying medical condition in which case consent could be signed by proxy\n7. Life expectancy of at least 2 months\n8. Females of childbearing potential must use highly effective method of contraception for the duration of the study and ≥ 30 days after the last dose of zanubrutinib. Female must also have a negative urine or serum pregnancy test ≤ 7 days before initial treatment.\n\n   * The investigator or a designated associate is requested to advise the patients how to achieve highly effective birth control (failure rate of less than 1%), e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner and sexual abstinence. Females using hormonal contraception should use barrier methods in addition.\n   * Male patients with a female partner of childbearing potential are eligible if abstinent, vasectomized, or if they agree to the use of barrier contraception with other methods described above during the study treatment period and for up to one week after the last dose of zanubrutinib.\n\n   Agreement to use contraception during study participation\n   * Female patients of childbearing potential must practice highly effective methods of contraception.\n   * Male patients with female partners must be abstinent, vasectomized, or agree to the use of barrier contraception in combination with other methods. Acceptable contraception methods are included in the study protocol.\n   * Patients using hormonal contraceptives (e.g., birth control pills or devices) must use a barrier method of contraception (e.g., condoms) as well.\n9. For patients with Infectious disease, must have:\n\n   1. HIV positive with negative viral load and CD4 count \\> 400\n   2. Non-viremic Hepatitis C Virus (HCV)\n   3. HBcAb (Hepatitis B core positive) and HBsAg negative\n\nExclusion Criteria:\n\n1. Serious uncontrolled concurrent illness or comorbid condition\n2. Other active systemic malignancy except for basal cell carcinoma of the skin, cervical carcinoma in situ or very low and low risk prostate cancer under observation. Patients with a remote history (3 years or more) of malignancy are eligible for the protocol in the absence of active disease\n3. Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol\n4. Unable to comprehend the study requirements or who are not likely to comply with the study protocol\n5. Prior participation in chemotherapy, cytotoxic therapy, immunotherapy, radiation therapy or therapeutic protocols within 2 weeks of protocol treatment\n6. Pregnant (confirmed by serum or urine β-HCG) or lactating\n7. Transaminases \\> 3 times above the upper limits of the institutional normal\n8. Patients must not have pre-existing immunosuppression, concurrent immunosuppressive treatment with the exception of dexamethasone, or low dose prednisone with a total dose equivalent to 15 mg of prednisone a day or less for chronic conditions. Allogeneic stem cell transplant recipients as well as other organ transplant recipients are excluded. Autologous stem cell transplant recipients will qualify if relapse occurs at one year after the stem cell transplantation. Short course of dexamethasone up to 40 mg orally or intravenously daily with or without taper for CNS lymphoma symptom control is allowed.\n9. Patients should not have active and\u002For ongoing autoimmune anemia and\u002For autoimmune thrombocytopenia (e.g., idiopathic thrombocytopenia purpura).\n10. Non-healing wound, ulcer or bone fracture\n11. Known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia\n12. Cerebrovascular accident or intracranial hemorrhage within 6 months of the study treatment; arterial or venous thrombotic or embolic event such as deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment. Patients with upper extremity catheter-related deep venous thrombosis will not be excluded.\n13. Concurrent use of warfarin or other vitamin K antagonists (need to be stopped 7 days prior to starting on trial drug)\n14. Infectious disease: HIV positive patients with positive viral load and CD4+ count \\\u003C 400 are excluded. HIV patients must have established and consistent infectious disease specialist care. HIV positive patients have to agree for every 12-week monitoring of viral load. Patients with the emergence of HIV viral load on the trial treatment will be referred to the infectious disease specialist and can continue on the trial treatment unless recommended to stop by the infectious disease specialist and PI. If the viral load reaches 100,000 copies per milliliter or above, the patient would be referred to an infectious disease specialist for and evaluation and would be taken off the trial.\n15. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable and if they are willing to undergo monitoring for HCV reactivation every 12 weeks. HCV patients will be taken off trial if there is 1 log increase in viral load after the initial detection of HCV viral load regardless of liver function tests (LFTs). Patients will be referred promptly to hepatology specialist with the first detectable viral load.\n16. Patients with detectable hepatitis B surface antigen (HBsAg) are excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, are eligible if HBV DNA is undetectable and if they are willing to undergo monitoring for Hepatitis B Virus (HBV) reactivation every 12 weeks. HBV patients will be taken off trial if there is 1 log increase in viral load after the initial detection of HBV viral load regardless of LFTs. Patients will be referred promptly to hepatology specialist with the first detectable viral load.\n17. Currently active, clinically significant cardiovascular disease including the following:\n\n    1. Myocardial infarction within 6 months before screening\n    2. Unstable angina within 3 months before screening\n    3. New York Heart Association class III or IV congestive heart failure\n    4. History of clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes)\n18. Any uncontrolled active systemic infection or infection requiring systemic treatment that was completed ≤ 7 days before the first dose of therapy\n19. Participants who received a strong cytochrome P450 (CYP) 3A inhibitor or inducer within 7 days prior to the first dose of protocol anti-fungal prophylaxis, or participants who require continuous treatment with a strong CYP3A inhibitor\u002Finducer (i.e., except for any medication to be specifically mentioned in this protocol)\n20. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety, or put the study at undue risk. Participants with suspicious radiologic evidence of aspergillosis infection (i.e., chest CT and\u002For brain MRI) will not be eligible unless confirmatory laboratory testing of Beta-D glucan and aspergillus antigen are negative\n21. Prior treatment with pemetrexed or a Bruton's tyrosine kinase (BTK) inhibitor for lymphoma\n22. Vaccination with a live or attenuates vaccine within 28 days prior to the first dose of zanubrutinib. Live or attenuated vaccines are not allowed during treatment with zanubrutinib\n23. Hypersensitivity to zanubrutinib or pemetrexed or any of the other ingredients of the applicable study drug",{"count":138,"type":20},15,[114],"This study is being conducted to evaluate the safety and efficacy of the combination of pemetrexed and zanubrutinib (called induction therapy) followed by zanubrutinib treatment alone (also called maintenance therapy) in people who have relapsed or refractory (RR) primary central nervous system lymphoma (PCNSL) or isolated central nervous system relapse of B cell lymphoma (SCNSL). Assessments include how well people respond to this treatment, whether their disease gets better or worse, and their survival. Safety of this treatment and its side effects also will be assessed.",[27,31,142,143],"Relapsed Cancer","Refractory Cancer","2026-03-02",{"date":146,"type":46},"2026-03-03",{"date":148,"type":46},"2024-04-25",{"date":150,"type":20},"2033-02",{"name":152,"class":52},"Baptist Health South Florida",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":102},"100586993","phase-1-glofitamab-with-obinutuzumab-pre-treatment-for-the-treatment-of-central-nervous-system-lymphoma-100586993","NCT06922604","Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma","A Phase 1b Study of Glofitamab in CNS Lymphoma","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Karnofsky performance status (KPS) ≥ 30\n* Histologically confirmed primary or secondary CNS lymphoma. Tumor must be positive for CD20 by immunohistochemistry or flow cytometry on the most recent biopsy. Neuroimaging alone is acceptable in secondary CNS lymphoma cases where all of the following criteria are met: 1) brain MRI findings are consistent with CNS lymphoma, 2) the disease has been histologically documented in other sites, 3) the CNS lesions are concomitant with systemic progression, and 4) a brain biopsy would be unadvised per the treating provider.\n\n  * Cohort 1: Primary CNS lymphoma\n  * Cohort 2: Secondary CNS lymphoma\n* Patients must not require urgent treatment initiation due to bulky or rapidly progressing CNS lymphoma that poses risk for impending critical brain failure. This includes \\> 5 mm of midline shift, radiographic evidence of impending brain herniation, or clinical evidence of significantly increased intracranial pressure such as papilledema\n* Have failed methotrexate-based therapy or are ineligible\u002Frefuse high-dose methotrexate treatment (e.g. creatinine clearance \\[CrCl\\] \\\u003C 50 mL\u002Fmin, effusions, ascites etc)\n* Measurable CNS lymphoma based on gadolinium enhancement of brain or spine MRI and\u002For positive CSF or intravitreal fluid cytology\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Alert and able to participate in a full neurological exam\n* Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: ANC ≥ 500\u002Fmm\\^3\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Without bone marrow involvement: Platelets ≥ 75,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* With bone marrow involvement: Platelets ≥ 50,000\u002Fmm\\^3\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin ≥ 8.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease, then ≤ 3.0 x ULN is allowed)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Creatinine clearance of ≥ 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n* If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: PT must be within therapeutic range of intended use of anticoagulants\n* If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n* If on anticoagulant therapy: aPTT must be within therapeutic range of intended use of anticoagulants\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo\n\n  * Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count ≥ 200\u002FuL, and have an undetectable viral load\n* Seronegative for active hepatitis B virus (HBV) (surface antigen negative)\n\n  * Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative hepatitis B virus surface antigen \\[HBsAg\\]) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated\n* Seronegative for HCV\n\n  * Participants positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* Women of childbearing potential (WOCBP): Negative serum pregnancy test\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study and after completion of study treatment as described below separately for males and females\n\n  * Female participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 18 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab and 3 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period\n\n    * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices\n    * Hormonal contraceptive methods must be supplemented by a barrier method\n  * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below:\n\n    * With a female partner of childbearing potential or pregnant female partners, male participants 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 3 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period\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 individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.\n  * Childbearing potential defined as not being permanently surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Prior solid organ transplantation\n* Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune\u002Fcytokines and monoclonal antibodies (mAbs) (e.g., anti cytotoxic T lymphocyte associated protein 4, anti PD-1, and anti PD-L1) within 2 weeks or five half-lives of the drug, whichever is shorter, prior to day 1 of protocol therapy\n* Prior treatment with glofitamab or other CD20 x CD3 bispecific antibodies\n* Prior use of systemic chemotherapy within 2 weeks of the start of cycle 1\n* Prior treatment with intrathecal chemotherapy within 1 week of the start of cycle 1. Note, in patients with lymphoma restricted to the CSF and no other measurable sites of CNS disease, positive CSF cytology must be documented following the most recent administration of intrathecal chemotherapy\n* Prior treatment with radiotherapy within 2 weeks prior to day 1 of protocol therapy\n\n  * If patients have received radiotherapy within 4 weeks prior to day 1 of protocol therapy, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible\n* Prior treatment with chimeric antigen receptor T cell (CAR-T) therapy within 30 days prior to day 1 of protocol therapy\n* Any investigational therapy for the purposes of treating cancer within 21 days prior to the start of cycle 1\n* Corticosteroid use for purposes other than lymphoma symptom control\n\n  * The use of inhaled corticosteroids is permitted\n  * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n  * Participants who require lymphoma symptom control during screening may receive steroids in the following manner:\n\n    * Up to 50 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening\n* History of other malignancy that could affect compliance with the protocol or interpretation of results:\n\n  * Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible\n  * Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \\> 2 years prior to enrollment are eligible\n  * Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n  * If the malignancy is expected to not require any treatment for at least 2 years (this exception should be discussed with the study PI)\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 3 months\n  * NYHA (New York Heart Association) heart failure class III-IV\n  * Unstable arrhythmias, or unstable angina\n* Recent major surgery within 4 weeks prior to the start of cycle 1, other than for diagnosis\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease with the exception of CNS lymphoma. Exceptions can be granted after discussion with the PI of the study\n\n  * Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion\n* Known or suspected active infection, or reactivation of a latent infection, whether bacterial, viral, fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing\n* Active autoimmune disease requiring treatment with immune suppressive medications other than physiologic doses of steroids\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible\n  * Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible (e.g., participants with psoriatic arthritis are excluded) if all the following conditions are met:\n\n    * Rash covers \\\u003C 10% of body surface area\n    * Disease is well controlled for the last 12 months and requires only low potency topical corticosteroids\n* Clinically significant liver disease, including active viral or other hepatitis or cirrhosis\n* Live, attenuated vaccine within 4 weeks before study treatment infusion on day 1 of cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited\n\n  * Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period\n* Suspected active or latent tuberculosis (as confirmed by a positive interferon gamma release assay)\n* Participants with a history of progressive multifocal leukoencephalopathy\n* Females only: Pregnant or breastfeeding or intention of becoming pregnant during the study or within 18 months after pretreatment with obinutuzumab or 2 months after the final dose of glofitamab, whichever is longer\n* Any other condition that would, in the investigator's judgment, contraindicate the patient'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":161,"type":20},20,[23],"This phase Ib trial tests the safety and side effects of glofitamab after pre-treatment with obinutuzumab and how well they work in treating patients with central nervous system (CNS) lymphoma. Glofitamab is a bispecific antibody that can bind to two different antigens (substances that cause the body to make a specific immune response) at the same time. Glofitamab binds to CD20 on lymphoma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Obinutuzumab can also be administered as a pre-treatment to make glofitamab safer and more tolerable. Giving glofitamab with obinutuzumab pre-treatment may be safe, tolerable, and\u002For effective in treating patients with CNS lymphoma.",[27,31],"2025-11-06",{"date":167,"type":46},"2025-11-10",{"date":169,"type":46},"2025-07-30",{"date":171,"type":20},"2029-01-02",{"name":173,"class":52},"City of Hope Medical Center",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":102},"100466273","phase-1-tafasitamab-plus-lenalidomide-in-relapsed-cns-lymphoma-100466273","NCT05351593","Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma","A Phase I\u002FII Study of Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma","Inclusion Criteria:\n\n1. Participants must have relapsed primary or secondary CNS lymphoma, diffuse large B-cell lymphoma (DLBCL) type, based on radiographic, ophthalmologic, or CSF criteria (evidence of malignant cells based on CSF studies: cytospin\u002Fcytology and flow-cytometry).\n\n   1. Concomitant systemic lymphoma as well as transformation from follicular lymphoma and\u002For Chronic lymphocytic leukemia (CLL) to an aggressive B-cell histology is allowed.\n   2. Participants are eligible with disease in each CNS compartment: brain, leptomeninges\u002FCSF and intraocular compartment.\n2. Age \\>= 18 years.\n3. Anticipated survival \\> 2 months, as determined by the investigator.\n4. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C=1 (Karnofsky performance status \\>= 70%)\n5. Demonstrates adequate organ function as defined below:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 X 10\\^9\u002F L (1,500\u002F microliter (mcL), growth factors permitted).\n   2. Platelets \\>= 50 X 10\\^9 \u002F L (50,000\u002F mcL, platelet transfusion independent).\n   3. Total bilirubin \\\u003C= 1.5 x institutional upper limit of normal,unless elevated due to Gilbert's syndrome.\n   4. Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase (SGOT) \\\u003C=3 X institutional upper limit of normal.\n   5. Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase (SGPT) \\\u003C=3 X institutional upper limit of normal.\n\n   d. Creatinine clearance (CrCl, calculated) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2, calculated using the Cockcroft-Gault equation. CrCl \\> 60 mL\u002Fmin\u002F1.73 m2 is requisite for eligibility for the phase I dose-escalation phase of the study.\n6. Ability to understand and the willingness to sign a written informed consent document.\n7. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. If a HBV test comes up positive due to Intravenous immunoglobulin (IVIG) and the participant has no prior history of HBV, then perform a HBV PCR to confirm.\n\n   undetectable disease.\n8. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n9. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n10. The effects of the study drugs on the developing human fetus are unknown. For this reason, and because the teratogenic effect of lenalidomide in humans cannot be ruled out, females of child-bearing potential (FCBP) and men must agree to use adequate contraception. FCBP must agree to undergo pregnancy testing as required in the study protocol. Should a woman become pregnant or suspect they are pregnant while their partner is participating in this study, they should inform her treating physician immediately.\n11. Prior Therapies\n\n    1. Participants with CNS lymphoma involving the brain parenchyma must have received at least one prior systemic therapy.\n    2. Participants with secondary CNS lymphoma must have received prior CNS-directed treatment.\n    3. There is no limit in terms of prior lines of therapy received. Patients may have progressed after prior treatment with IMiD's (including lenalidomide, pomalidomide and CC122), patients may have had prior rituximab or other anti-CD20 based therapy as well as autologous and allogeneic stem cell transplant. Patients who progress after prior stem cell transplant are immediately eligible whereas patients that progress after anti-CD19-based therapy including CAR-T based therapy are not eligible.\n12. Recipients of prior hematopoietic stem cell transplant are eligible as long as the following criteria are met:\n\n    1. Absence of graft versus host disease.\n    2. Discontinuation of systemic immunosuppressant therapy.\n\nExclusion Criteria:\n\n1. Has received systemic anti-cancer therapies within 2 weeks of first dose, radiation within 1 week, antibody therapy within 4 weeks.\n2. Has not recovered from adverse events due to prior anti-cancer therapy to ≤ grade 1 or baseline (other than alopecia).\n3. Is currently receiving any other investigational agents.\n4. Has participated in a study of an investigational product and received study treatment or used an investigational device within four weeks of the first dose of treatment.\n5. Has a history of HIV infection.\n6. Has CNS post-transplant lymphoproliferative disease (PTLD).\n7. Has known hypersensitivity to lenalidomide or Tafasitamab.\n8. Pregnant women and women of child-bearing potential who will not using an effective method of birth control (detailed in Appendix 3) are excluded from this study because the study drugs have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide and\u002For Tafasitamab, breastfeeding should be discontinued if the mother is treated with study drugs.\n9. Prior receipt of anti-CD19 based therapy including anti-CD19, Chimeric antigen receptor T cells (CAR-T) therapy is an exclusion criteria.\n10. Has any significant medical condition or comorbidity that could compromise patient safety (e.g., uncontrolled serious infection).",{"count":182,"type":20},35,[23,114],"This is a single arm open-label multicenter phase I\u002FII investigation of combination lenalidomide\u002FTafasitamab in patients with relapsed central nervous system (CNS) lymphoma. This is the first study to examine a naked anti-CD19 monoclonal antibody in relapsed CNS lymphoma patients as well as the combination of anti-CD19 antibody plus an Immunomodulatory imide drugs (IMiDs) in CNS lymphomas. This study will also test the novel hypothesis that Tafasitamab enhances blood-brain barrier permeability, a potential property that could have broad clinical implications.",[186,27,31],"CNS Lymphoma","2025-01-30",{"date":189,"type":46},"2025-02-03",{"date":191,"type":46},"2022-06-08",{"date":193,"type":20},"2026-06-30",{"name":195,"class":52},"James Rubenstein"]