[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-central-nervous-system-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-central-nervous-system-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,54,84,108,131,151,175,196,253,276,299,321,346,367,388,418,439,459,482,503,525],{"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":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100619917","phase-2-a-multicenter-prospective-clinical-trial-with-a-concurrent-control-evaluating-methotrexate-combined-with-rituximabsintilimab-and-pirtobrutinib-vs-investigator-selected-standard-of-care-in-treatment-naive-pcnsl-100619917","NCT07350850","A Multicenter, Prospective Clinical Trial With a Concurrent Control Evaluating Methotrexate Combined With Rituximab,Sintilimab and Pirtobrutinib vs. Investigator-Selected Standard of Care in Treatment-Naive PCNSL","In Treatment-Naive Patients With Primary Central Nervous System Lymphoma (PCNSL): A Multicenter, Prospective, Concurrent-Control Study of Methotrexate, , Rituximab,, Sintilimab ,Pirtobrutinib Versus Investigator-Selected Standard of Care","PRIME-PCNSL","Inclusion Criteria:\n\n1. Age \\>= 18 years.\n2. Voluntarily signed informed consent.\n3. ECOG Performance Status 0-3.\n4. Expected survival \\> 3 months.\n5. Histopathologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) restricted to the CNS or eyes (PCNSL).\n6. Measurable lesion on contrast-enhanced MRI (\\>10x10 mm) or positive CSF cytology for leptomeningeal disease.\n7. No prior systemic treatment for lymphoma (corticosteroids excepted).\n8. Adequate bone marrow and organ function (ANC \\>=1.5x10\\^9\u002FL, PLT \\>=80x10\\^9\u002FL, Hb \\>=80 g\u002FL; Bilirubin \\\u003C=1.5xULN, AST\u002FALT \\\u003C=2.5xULN; Creatinine \\\u003C=1.5xULN or CrCl \\>=60 mL\u002Fmin) .\n9. Stable controlled comorbidities allowed (e.g., hypertension with blood pressure \\\u003C=160\u002F100 mmHg, type 2 diabetes with HbA1c \\\u003C=8%, mild coronary heart disease without myocardial infarction in the past 6 months).\n10. Basic communication ability to complete PROs questionnaires (no severe cognitive impairment).\n11. Reproductive-aged females and males with childbearing potential: No pregnancy plans during the study and 3 months after treatment discontinuation; use effective contraception (abstinence, physical contraception, or hormonal contraceptives initiated \\>=3 months before first dose). Males prohibited from donating sperm during treatment and 3 months after discontinuation.\n12. For Observational Cohort (Palliative Care Subgroup only): Pathologically confirmed DLBCL restricted to the CNS or eyes; Follow-up available for efficacy assessment (at least one CR evaluation) .\n\nExclusion Criteria:\n\n1.Prior treatment with PD-1\u002FPD-L1 inhibitors or CTLA4 monoclonal antibodies. Uncontrolled active infection. 2.Uncontrolled or significant cardiovascular diseases: 3.Congestive heart failure (NYHA class III\u002FIV),\n\n1. myocardial infarction, unstable angina within 6 months before first dose; arrhythmia requiring treatment; LVEF \\\u003C50%.\n2. Primary cardiomyopathy.\n3. History of clinically significant QTc prolongation, second-degree type II\u002Fthird-degree atrioventricular block, or QTc interval (Fridericia method) \\>470 msec (females) \u002F \\>480 msec (males).\n4. Atrial fibrillation (EHRA grade ≥2b).\n5. Refractory hypertension. 4.Active hepatitis B\u002FC infection (HBV-DNA ≥ detection limit, HCV RNA positive) or syphilis. (Exceptions: HBV-DNA \\\u003C detection limit, cured HCV).\n\n5.HIV infection. 6.Prior organ transplantation or allogeneic stem cell transplantation. 7.Pregnant or lactating females. 8.Prior\u002Fcurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis (unsuitable for study per investigator).\n\n9.Autoimmune diseases requiring systemic treatment within 2 years. 10.For Observational Cohort (Palliative Care Subgroup only): Incomplete clinical data (e.g., no pathological report, inability to perform MRI\u002FPET-CT assessment).",{"count":63,"type":20},77,[65],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of a four-drug combination regimen as first-line treatment for adults aged 18 years and older with newly diagnosed primary central nervous system lymphoma (PCNSL). The main questions it aims to answer are:\n\nDoes the combination of pirtobrutinib, sintilimab, rituximab, and high-dose methotrexate achieve a higher complete response rate than standard treatment for newly diagnosed PCNSL? What is the safety and tolerability profile of this four-drug combination regimen? Researchers will compare the experimental four-drug combination to investigator-selected standard-of-care regimens (all based on high-dose methotrexate) to see if the experimental regimen improves complete response rate, progression-free survival, and overall survival while maintaining an acceptable safety profile.\n\nParticipants will:\n\nBe assigned to either the experimental group or the standard treatment group based on their personal preference Receive 6 cycles of induction therapy (21 days per cycle) with their assigned treatment regimen Undergo regular clinical assessments, including contrast-enhanced brain MRI scans, blood tests, and cerebrospinal fluid examinations Complete the EORTC QLQ-C30 quality-of-life questionnaire at baseline, mid-treatment, end of treatment, and follow-up visits Receive optional consolidation or maintenance therapy based on their response to induction treatment Be followed for up to 2 years after completing treatment to monitor for disease progression and long-term outcomes",[34,27],[26,69,70,71,72,73],"Methotrexate","Rituximab","Sintilimab","Pirtobrutinib","Real-World Evidence","2026-05-30",{"date":76,"type":46},"2026-06-02",{"date":78,"type":46},"2025-12-25",{"date":80,"type":20},"2029-06-30",{"name":82,"class":52},"Tongji Hospital",4,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"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":92,"type":20},15,[65],"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.",[27,31,96,97],"Relapsed Cancer","Refractory Cancer","2026-03-02",{"date":100,"type":46},"2026-03-03",{"date":102,"type":46},"2024-04-25",{"date":104,"type":20},"2033-02",{"name":106,"class":52},"Baptist Health South Florida",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100552603","phase-1-pembrolizumab--chemotherapy-in-newly-diagnosed-pcnsl-100552603","NCT06475235","Pembrolizumab + Chemotherapy in Newly Diagnosed PCNSL","A Pilot Study of Pembrolizumab in Combination With Chemotherapy in Newly Diagnosed Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n* Subjects with pathologically confirmed newly diagnosed primary CNS diffuse large B-cell lymphoma (DLBCL) confirmed by one of the following:\n\n  * Brain biopsy or resection\n  * Cerebrospinal fluid\n  * Vitreous fluid\n* Participants must not have any evidence or history of DLBCL outside of the CNS. Participants with prior history of isolated intraocular lymphoma (primary vitreoretinal lymphoma\u002FPVRL) who have received only local therapy are allowed.\n* Participants must not have received any systemic chemotherapy or whole brain radiation therapy directed to PCNSL.\n* Age ≥18 years.\n* ECOG performance status ≤2 (Karnofsky ≥70% will be considered if related to PCNSL, see Appendix A).\n* Participants must have adequate organ function as defined below.\n* Hematology\n\n  * Absolute neutrophil count (ANC) ≥1000\u002FµL\n  * Platelets ≥100 000\u002FµL\n  * Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)\n* Renal\n\n  \\-- Creatinine ≤1.5 x ULN OR Measured or calculated creatinine clearance ≥40 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN (Creatinine clearance (CrCl) should be calculated per institutional standard.)\n* Hepatic\n\n  * Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 x ULN\n  * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases)\n* Coagulation\n\n  --International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Participants must have negative HIV serology.\n* Participants must have no history of organ transplantation or ongoing immunosuppressant therapy.\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy within 72 hours prior to registration.\n* Women in the following categories are not considered WOCBP:\n\n  * Premenarchal\n  * Premenopausal female with 1 of the following:\n\n    * Documented hysterectomy\n    * Documented bilateral salpingectomy\n    * Documented bilateral oophorectomy\n  * Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.\n* Post-menopausal female is defined as no menses for 12 months without an alternative medical cause.\n\n  * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.\n  * Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n* Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study discontinuation.\n\n  * 1\\. Highly Effective Contraceptive Methods That Are User Dependent (Failure rate of \\\u003C 1% per year when used consistently and correctly.)\n\n    * a. Combined (estrogen- and progestogen- containing) hormonal contraception\n\n      * i. Oral\n      * ii. Intravaginal\n      * iii. Transdermal\n      * iv. Injectable\n    * b. Progestogen-only hormonal contraception b, c\n\n      * i. Oral\n      * ii. Injectable\n  * 2\\. Highly Effective Methods That Have Low User Dependency (Failure rate of \\\u003C1% per year when used consistently and correctly)\n\n    * a. Progestogen- only contraceptive implant b, c\n    * b. Intrauterine hormone-releasing system (IUS) b\n    * c. Intrauterine device (IUD)\n    * d. Bilateral tubal occlusion\n    * e. Vasectomized partner: A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n    * f. Sexual abstinence: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n* NOTES: Use should be consistent with local regulations regarding the use of contraceptive methods for participants of clinical studies.\n\n  * a. Typical use failure rates are lower than perfect-use failure rates (i.e. when used consistently and correctly).\n  * b. If hormonal contraception efficacy is potentially decreased due to interaction with study treatment, condoms must be used in addition to the hormonal contraception during the treatment period and for at least during study treatment and for 120 days after study discontinuation after the last dose of study treatment.\n  * c. If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive implants are limited to those which inhibit ovulation.\n* Male participants must to use at least one of the following methods of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy:\n\n  * Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent\n  * Use a male condom plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year as described in Eligibility criterion 3.1.11 when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.\n* Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile- vaginal intercourse or use a male condom during each episode of penile penetration.\n\nExclusion Criteria:\n\n* Participants who cannot undergo MRI\n* Intraocular PCNSL without evidence of brain or spinal cord disease.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions or severe hypersensitivity reactions (≥grade 3) attributed to compounds of similar chemical or biologic composition to study agent and\u002For any of its excipients.\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137)\n* Has active autoimmune disease requiring immunosuppressives or steroids\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. COVID19 vaccines are allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin \\>8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of \\>8%.\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.\n* Enzyme-inducing antiepileptic drugs (EIAED) need to be discontinued and switched to a non-EIAED 2 weeks prior to starting on trial drugs\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)\n* Patients who have undergone prior allogeneic stem cell transplant\n* Patients who have large pleural effusions, ascites or full body edema\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment",{"count":92,"type":20},[23],"This research study is studying if the investigational drug, Pembrolizumab, in combination with chemotherapy helps primary central nervous system lymphoma with acceptable side effects.\n\nThis research study involves a combination of the below drugs:\n\n* Pembrolizumab (a type of monoclonal antibody)\n* Methotrexate (a type of anti-metabolite)\n* Temozolomide (a type of alkylating agent)\n* Rituximab (a type of antibody)",[119,27],"Lymphoma",[119,27],"2026-02-18",{"date":123,"type":46},"2026-02-20",{"date":125,"type":46},"2024-10-18",{"date":127,"type":20},"2027-06-30",{"name":129,"class":52},"Dana-Farber Cancer Institute",2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":83},"100394860","phase-1-pembrolizumab-ibrutinib-and-rituximab-in-pcnsl-100394860","NCT04421560","Pembrolizumab, Ibrutinib and Rituximab in PCNSL","A Phase Ib\u002FII Study of Pembrolizumab, Ibrutinib and Rituximab in Refractory\u002FRelapsed Primary Central Nervous System Lymphoma (PCNSL)","Inclusion Criteria:\n\n* Participant must be able to understand and willing to sign a written informed consent document.\n* Participant must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.\n* Participant must be at least 18 years old on day of signing informed consent.\n* Subjects with pathologically confirmed PCNSL who progressed after CNS-directed therapy, primary refractory disease and relapsed disease are allowed. Participants should have evidence of R\u002FR disease on MRI or CSF cytology. Ocular only recurrences are allowed.\n* Subjects must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Life expectancy of \\>3 months (in the opinion of the investigator)\n* Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1\n* Must be able to tolerate lumbar puncture and\u002For Ommaya taps\n* Demonstrate adequate organ function as defined below, all screening labs should be performed within 28 days of treatment initiation.\n\n  * Hematology\n\n    * White Blood Count (WBC) ≥ 2 K\u002FμL\n    * Platelet count ≥ 100 K\u002FμL\n    * Absolute Neutrophil Count ≥ 1.5 K\u002FμL\n    * Hemoglobin \\> 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)\n  * Biochemistry\n\n    * Serum creatinine ≤1.5 x institutional ULN OR Measured or calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN (Creatinine clearance should be calculated per institutional standard)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN(≤5 × ULN for participants with liver metastases)\n    * Total bilirubin (TBILI) ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of \\\u003C 3.0 x institutional ULN) OR Direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN)\n  * Coagulation studies\n\n    * INR OR PT and Activated aPTT ≤1.5 × institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative serum pregnancy test within 72 hours prior to registration.\n* Women in the following categories are not considered WOCBP:\n\n  * Premenarchal\n  * Premenopausal female with 1 of the following:\n\n    * Documented hysterectomy\n    * Documented bilateral salpingectomy\n    * Documented bilateral oophorectomy\n    * Note: Documentation can come from the site personnel's review of the participant's medical records, medical examination, or medical history interview.\n  * Postmenopausal female: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n\n    * A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with two FSH measurements in the postmenopausal range is required.\n  * Females on HRT and whose menopausal status is in doubt will be required to use one of the non-hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.\n* Women of child-bearing potential (WOCBP; see definition above), must agree to use a highly effective method of contraception consistently and correctly as described below during study treatment and for 120 days after study discontinuation.\n\n  * 1\\. Highly Effective Contraceptive Methods That Are User Dependent a (Failure rate of \\\u003C 1% per year when used consistently and correctly.)\n\n    * a. Combined (estrogen- and progestogen- containing) hormonal contraception b, c\n\n      * i. Oral\n      * ii. Intravaginal\n      * iii. Transdermal\n      * iv. Injectable\n    * b. Progestogen-only hormonal contraception b, c\n\n      * i. Oral\n      * ii. Injectable\n  * 2\\. Highly Effective Methods That Have Low User Dependency (Failure rate of \\\u003C1% per year when used consistently and correctly)\n\n    * a. Progestogen- only contraceptive implant b, c\n    * b. Intrauterine hormone-releasing system (IUS) b\n    * c. Intrauterine device (IUD)\n    * d. Bilateral tubal occlusion\n    * e. Vasectomized partner: A vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used.\n    * f. Sexual abstinence: Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n  * NOTES: Use should be consistent with local regulations regarding the use of contraceptive methods for participants of clinical studies.\n\n    * Typical use failure rates are lower than perfect-use failure rates (i.e. when used consistently and correctly).\n    * If hormonal contraception efficacy is potentially decreased due to interaction with study treatment, condoms must be used in addition to the hormonal contraception during the treatment period and for at least during study treatment and for 120 days after study discontinuation after the last dose of study treatment.\n    * If locally required, in accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive implants are limited to those which inhibit ovulation.\n* Male participants must agree to use at least one of the following methods of contraception starting with the first dose of study therapy through 120 days after the last dose of therapy:\n\n  * 1\\. Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent\n  * 2\\. Use a male condom plus partner use of a contraceptive method with a failure rate of \\\u003C1% per year as described in Eligibility criterion 3.1.13 when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant.\n  * a. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will not be eligible for admission into the study.\n\n* Patients who cannot undergo MRI brain\n* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40,CD137)\n* Previously progressed on ibrutinib or other BTK inhibitor use (patient who have previously received BTK inhibitor but not progressed while on it are allowed)\n* Patients with \\> Grade 2 intracranial hemorrhage\n* Concomitant warfarin, any other warfarin-derivative anticoagulant, vitamin K antagonists, within 7 days before starting treatment. Note: novel oral anticoagulants (NOACs, e.g., Apixaban, Dabigatran, Edoxaban, Rivaroxaban), low molecular weight heparin (LMWH) are allowed\n* Arterial thromboembolic events such as cerebrovascular accident within 3 months before the start of study treatment\n* Active autoimmune disease requiring immunosuppressive agents or steroids (prednisone \\>10mg or equivalent)\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Requires treatment for PCNSL with high dose systemic corticosteroids defined as dexamethasone \\> 4 mg\u002Fday or bioequivalent for \\>3 consecutive days within 2 weeks of registration\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks \\[could consider shorter interval for kinase inhibitors or other short half-life drugs\\] prior to dosing. OR 5 half-lives, whichever is shorter --- Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with≤Grade 2 neuropathy may be eligible.\n* Patients who underwent major surgery ≤ 2 weeks before starting study treatment are excluded. If participant underwent major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment. Patients who plan to undergo surgery within 2 weeks of first dose of study treatment are excluded.\n* Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease. Has received prior radiotherapy to CNS disease within 2 weeks of start of study treatment.\n* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella,varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has severe hypersensitivity (≥ Grade 3) to study agents and\u002For any of its excipients.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Patient is known to have an uncontrolled active systemic infection (\\>CTCAE grade 2) and recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug.\n* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association \\> Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Uncontrolled hypertension despite optimal medical management (per investigator's assessment).\n* Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin \\>8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of \\>8%.\n* Non-healing wound, ulcer or bone fracture.\n* Known bleeding diathesis (eg, von Willebrand's disease) or hemophilia.\n* Unable to swallow capsules or disease significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.\n* Concurrent administration of medications or foods that are moderate or strong inhibitors or strong inducers of cytochrome P450 (CYP) 3A4\u002F5 (need to be discontinued 2 weeks before starting study treatment)\n* Enzyme-inducing antiepileptic drugs (EIAED) need to be discontinued and switched to a non-EIAED 2 weeks prior to starting on trial drugs\n* Has known history of HIV\u002FAIDS\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n* Has a known history of active TB (Bacillus Tuberculosis)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)\n* Patients who have undergone prior allogeneic stem cell transplant\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment",{"count":139,"type":20},37,[23,65],"This research study is evaluating a combination therapy of 3 drugs as possible treatments for recurrent primary central nervous system lymphoma (PCNSL).\n\nThe three drugs being used in the study are:\n\n* Pembrolizumab (MK3475)\n* Ibrutinib\n* Rituximab (or biosimilar)",[27,143,97,96],"Recurrent Cancer",[27,143,97,96],{"date":123,"type":46},{"date":147,"type":46},"2020-08-01",{"date":149,"type":20},"2027-01-05",{"name":129,"class":52},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":107},"100624176","methotrexate-early-toxicity-monitoring-100624176","NCT07406230","Methotrexate Early Toxicity Monitoring","Methotrexate Early Toxicity Monitoring in Primary Central Nervous System Lymphomas (PCNSL)","METoxiM","Inclusion Criteria:\n\n* Adult patient aged 18 years or older,\n* Patient with a primary lymphoma of the central nervous system, histologically or cytologically proven,\n* Patient eligible for high-dose methotrexate treatment (\\> at 500 mg\u002Fm 2), in the first line of treatment,\n* Patient who has received information regarding the study and signed an informed consent,\n* Patient beneficiary or entitled to a social security scheme.\n\nExclusion Criteria:\n\n* Patient treated with a therapy complementary to the standard 1st-line treatment based on high-dose MTX as part of a clinical research protocol,\n* Patient in a period of exclusion from another research protocol at the time of signing consent,\n* Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patient, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman).",{"count":160,"type":20},50,[162],"NA","High-dose methotrexate (MTX) is the main componement of first line treatment in primary central nervous system lymphoma. Renal toxicity is the main dose limiting toxicity because of major MTX elimination by the kidneys. MTX crystallizes in renal tubules, leading to a renal failure (RF) and further delaying its elimination. When RF occurs, MTX accumulates, prolonging the duration of treatment exposure. MTX prolonging exposure can cause life-threatening complications and delay further treatments in the patient. Preventive measures have been developped, such as alkaline fluid hyperhydration and folic acid administration, to try to reduce the risk of these adverse events.\n\nIn suspected severe RF in link to MTX is suspected, glucarpidase can be administared. However, this is an expensive treatment and not all patients recover normal renal function despite its use.\n\nMTX is an essential treatment for the management of PCNSL which is currently a curable disease especially in patients who are able to receive a consolidation treatment as thiotepa-based intensive consolidation followed by autologous stem cell transplantation (IC-ASCT). IC-ASCT requires a normal renal function, which could be impaired by severe RF secondary to MTX.\n\nThe purpose of the study is to investigate how early dosing MTX could be used to simulate late concentrations. Early monitoring of MTX elimination could be implemented to identify patients at risk of delayed elimination and thus introduce rapid mesures as early administration of glucarpidase.",[27],"NOT_YET_RECRUITING","2026-02-05",{"date":168,"type":46},"2026-02-12",{"date":170,"type":20},"2026-04",{"date":172,"type":20},"2027-12",{"name":174,"class":52},"Assistance Publique Hopitaux De Marseille",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":107},"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":183,"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":189,"type":46},"2025-11-10",{"date":191,"type":46},"2025-07-30",{"date":193,"type":20},"2029-01-02",{"name":195,"class":52},"City of Hope Medical Center",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":130},"100570866","phase-1-q702-for-the-treatment-of-patients-with-hematologic-malignancies-100570866","NCT06712810","Q702 for the Treatment of Patients With Hematologic Malignancies","MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician\n* PRE-REGISTRATION: Patients must meet one of the following criteria:\n\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.\n\n    * Note: Relapsed is defined as a relapse that occurred after having a response to the last therapy at any point during the treatment. Refractory is no response (stable disease or progressive disease while on therapy) to a given treatment at least after 1 month of being on the given treatment.\n  * Newly diagnosed patients with Rosai-Dorfman disease without activating alterations in MAP2K oncogenes.\n  * Relapsed\u002Frefractory patients with Rosai-Dorfman disease and an activating mitogen-activated protein kinase (MAPK) pathway alteration who have failed prior treatment with cobimetinib.\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease or Langerhans histiocytosis who have received vemurafenib for BRAF V600E mutated disease or cobimetinib for disease with activating MAP2K alterations.\n  * Patients with Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans histiocytosis, histiocytic sarcoma, or another malignant histiocytosis who cannot tolerate or have a contraindication to BRAF or MEK inhibitors or those who cannot have reliable access to these inhibitors due to financial restraints or geographic location or initiation of BRAF or mitogen-activated protein kinase kinase (MEK) inhibitors is futile based on the genomic alterations or the discretion of treating physician.\n  * Relapsed\u002Frefractory higher risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF).\n\n    * Note: MF patients must have failed ≥ 1 of the 4 Food and Drug Administration (FDA)-approved Janus kinase (JAK) Inhibitors for MF (i.e. ruxolitinib, fedratinib, pacritinib, momelotinib) to be eligible. MDS and CMML patients must have failed hypomethylating agent-based therapy, if eligible.\n    * Note: Higher risk is defined as intermediate or higher risk by international prognostic scoring system (IPSS-R) or moderate high or higher risk as per molecular internal prognostic scoring system (IPSS-M).\n  * T cell lymphoma (peripheral and cutaneous), or mantle cell lymphomas. Patients must have failed ≥ 2 lines of therapy.\n  * Primary central nervous system (CNS) lymphoma who has failed ≥ 2 lines of therapy.\n  * Relapsed or refractory follicular lymphoma; or Waldenstrom macroglobulinemia\u002Flymphoplasmacytic lymphoma. Must have failed ≥ 2 lines of therapy.\n  * Patients with Waldenström macroglobulinemia who have received or are not eligible for a Bruton tyrosine kinase (BTK)-inhibitor therapy.\n  * Relapsed or refractory chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who have failed ≥ 2 lines of therapy and have been treated with at least one prior line of a BTK inhibitor and\u002For a B-cell lymphoma 2 (BCL2) inhibitor. Need documented CLL\u002FSLL requiring treatment according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018.\n\n    * NOTE: Use of oral steroids up to 20 mg of daily will be allowed for patients who are discontinuing BTK inhibitors just prior to the registration. This is not mandatory and should be done at the discretion of patient's treating physician.\n\n      * Note: All patients in the above disease groups may be on corticosteroids at the investigator's discretion\n* PRE-REGISTRATION: Histopathological or cytological confirmation of diseases\n* PRE-REGISTRATION: Willingness to provide mandatory blood, bone marrow aspirate, saliva, and tissue specimens for correlative research, as applicable to the disease site\n* PRE-REGISTRATION: Ability to swallow pills\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* REGISTRATION: Life expectancy of ≥ 3 months\n* REGISTRATION: Measurable or assessable disease:\n\n  * For histiocytic neoplasms and lymphoma-measurable disease is defined as measurable by CT (dedicated CT or the CT portion of a PET\u002FCT) or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of ≥ 1.5 cm for non-CNS disease. For CNS involved disease, MRI confirmation with any size would be appropriate.\n\n    * NOTE: Skin lesions can be used if the area is ≥ 1.5 cm in at least one diameter and photographed with a ruler. Patients with assessable disease by PET\u002FCT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic\u002Fdendritic cell neoplasms.\n  * For all other eligible diseases listed-N\u002FA\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 80 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: White blood cell (WBC) ≥ 2.5 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Alanine aminotransferase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Serum creatinine of ≤ 1.5 x ULN and calculated creatinine clearance of ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* REGISTRATION: Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.\n\n  * Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 2 years postmenopausal; or injectable or implantable agent\u002Fdevice\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study).\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active CNS metastases and\u002For carcinomatous meningitis.\n\n  * Note: Histiocytosis and lymphoma patients who are on steroids are allowed to enroll\n* REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* REGISTRATION: New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure ≤ 6 months prior to registration\n* REGISTRATION: Corrected QT interval (using Fridericia's correction formula) (QTcF) of \\> 470 msec\n* REGISTRATION: Known active infection with human immunodeficiency virus (HIV), Human T-lymphotropic virus 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV):\n\n  * Active infection with (HIV) and CD4+ T-cell count \\\u003C 350 μL.\n  * Patients with a detectable HIV viral load and not on antiretroviral therapy (ART) for ≥ 4 weeks.\n  * Exceptions:\n\n    * Patients with a history of hepatitis B or C are allowed if HBV deoxyribonucleic acid (DNA) or HCV ribonucleic acid (RNA) are undetectable.\n    * Patients with active HIV infection and CD4+ T-cell count ≥ 350 μL who are on active antiretroviral treatment\n* REGISTRATION: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* REGISTRATION: Concomitant use of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP2D6, and strong inhibitors and inducers of CYP3A4 within five half-lives of the active drug prior to registration and throughout the trial.\n\n  * Note: Strong inhibitors and inducers of CYP3A4 should be discontinued for five half-lives of the active drug prior to starting study drug and avoided throughout the trial\n* REGISTRATION: Concomitant use of any herbal supplements.\n\n  * Note: Supplements taken prior to starting study drug should be discussed with the Principal Investigator as varied washout periods may be clinically indicated and necessary\n* REGISTRATION: Any of the following prior therapies used as primary cancer treatment:\n\n  * Targeted therapeutics other than monoclonal antibodies (e.g., kinases inhibitors) ≤ 2 weeks prior to registration.\n  * Monoclonal antibodies ≤ 6 weeks, or ≥ 5 half-life, whichever is shorter, prior to registration.\n  * Chemotherapy ≤ 4 weeks prior to registration (6 weeks for nitrosoureas or Mitomycin C.\n  * Surgery ≤ 4 weeks prior to registration\n  * Any investigational therapy ≤ 4 weeks prior to registration\n  * Radiation therapy ≤ 4 weeks prior to registration\n\n    * Exceptions:\n\n      * Palliative radiation therapy ≥ 2 weeks prior to registration for control of tumor mass related symptoms (e.g., pain control from a discrete bone metastasis) allowed, unless the radiation field includes organs for which the radiation therapy could result in certain direct organ toxicities (e.g., radiation induced esophagitis), which could complicate the interpretation of the Q702 safety profile.\n      * Radiation induced toxicities which could interfere with the interpretation of the Q702 safety profile should recover to ≤ grade 1 before registration.\n      * Patients receiving palliative radiation intended to reduce the risk of a potential pathological fracture should be allowed ≥ 4 weeks from the last radiation therapy treatment to recover from any radiation induced toxicity and to allow for an adequate period of observation relative to the potential risk of a pathological fracture\n* REGISTRATION: Failure to recover from acute, reversible effects of prior therapy to ≤ grade 1 or patient baseline prior to registration.\n\n  * NOTE: Patient with chronic effects such as neuropathy, fatigue, keratitis\u002Fkeratopathy, anorexia, etc. are allowed\n* REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* REGISTRATION: Active retinal pigment epithelium (RPE)\u002Fphotoreceptor disorders such as retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration, retinal detachment, and opaque cornea. Exceptions:\n\n  * Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g., diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at the discretion of the ophthalmologist if deemed as not constituting evidence of pre-existing retinopathy (e.g., severe nonproliferative or proliferative diabetes retinopathy) or a condition with the potential to cause a predisposition to drug-induced retinopathy. \\[e.g., severe retinal vascular disease with scattered intraretinal hemorrhages, cotton wool-spots and intraretinal microvascular abnormalities (IRMA)\\]\n  * Patients with only one assessable eye and no evidence of pre-existing retinopathy may be allowed at the discretion of the principal investigator\n* REGISTRATION: Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy",{"count":204,"type":20},46,[23],"This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and\u002For effective in treating patients with hematologic malignancies.",[208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,27,233,234,235,236,237,238,239,240,241,242,243],"Hematopoietic and Lymphatic System Neoplasm","Histiocytic Sarcoma","Malignant Histiocytosis","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent Chronic Lymphocytic Leukemia","Recurrent Chronic Myelomonocytic Leukemia","Recurrent Follicular Lymphoma","Recurrent Langerhans Cell Histiocytosis","Recurrent Lymphoplasmacytic Lymphoma","Recurrent Myelodysplastic Syndrome","Recurrent Myelofibrosis","Recurrent Small Lymphocytic Lymphoma","Recurrent Waldenstrom Macroglobulinemia","Refractory Chronic Lymphocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","Refractory Erdheim-Chester Disease","Refractory Follicular Lymphoma","Refractory Langerhans Cell Histiocytosis","Refractory Lymphoplasmacytic Lymphoma","Refractory Myelodysplastic Syndrome","Refractory Myelofibrosis","Refractory Small Lymphocytic Lymphoma","Refractory Waldenstrom Macroglobulinemia","Rosai-Dorfman-Destombes Disease","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Recurrent Erdheim-Chester Disease","Recurrent Fibroblastic Reticular Cell Sarcoma","Recurrent Histiocytic Sarcoma","Recurrent Interdigitating Dendritic Cell Sarcoma","Recurrent Rosai-Dorfman-Destombes Disease","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Fibroblastic Reticular Cell Sarcoma","Refractory Histiocytic Sarcoma","Refractory Interdigitating Dendritic Cell Sarcoma","Refractory Rosai-Dorfman-Destombes Disease","2025-10-08",{"date":246,"type":46},"2025-10-10",{"date":248,"type":46},"2025-08-27",{"date":250,"type":20},"2030-09-15",{"name":252,"class":52},"Mayo Clinic",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":130},"100607193","phase-2-orelabrutinib-combined-with-teniposide-rituximab-and-methotrexate-for-newly-diagnosed-pcnsl-100607193","NCT07185373","Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL","Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed Primary Central Nervous System Lymphoma-A Randomized Controlled Trial","Inclusion Criteria:\n\n* No prior systemic treatment for primary central nervous system lymphoma\n* Pathologically confirmed as diffuse large B-cell lymphoma subtype; with sufficient residual surgical specimens remaining after meeting the needs for pathological diagnosis and preservation\n* Aged 18-75 years (inclusive)\n* ECOG performance status ≤3\n* Expected survival time exceeding 3 months\n* Major organ functions meeting the following standards:\n\n  1. Blood routine parameters (without growth factor support or blood transfusion within the past 7 days; 14 days for pegylated myeloid growth factors): absolute neutrophil count (ANC) ≥1.0×10⁹\u002FL, platelet count (PLT) ≥75×10⁹\u002FL, hemoglobin (Hb) ≥80g\u002FL;\n  2. Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) or ≤3×ULN (for confirmed Gilbert syndrome with direct bilirubin within normal range); aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5×ULN; serum creatinine within normal range; estimated glomerular filtration rate (eGFR) ≥70ml\u002Fmin;\n  3. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5×ULN;\n* Ability to tolerate lumbar puncture and\u002For having an indwelling Ommaya reservoir\n* Peripheral blood flow cytometry showed no clonal B cells and no other extramedullary lesions.\n* Voluntary signing of a written informed consent form by the participant or their legal representative prior to trial screening, indicating their understanding of the study purpose, necessary procedures, and willingness to comply with the protocol and attend follow-up visits\n\nExclusion Criteria:\n\n* Lymphoma involving sites outside the central nervous system (CNS)\n* Patients with a previous history of tumors\n* Patients with intraocular lymphoma or suspected diagnosis of intraocular lymphoma invasion\n* Uncontrolled or significant cardiovascular diseases, including:\n\n  1. New York Heart Association (NYHA) class Ⅲ-Ⅳ congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first administration of study drugs; clinically significant or treatment-requiring arrhythmias at screening; left ventricular ejection fraction (LVEF) \\\u003C50%; or patients with controlled coronary heart disease who are either not using anticoagulants\u002Fantiplatelet drugs or taking 2 or more anticoagulants\u002Fantiplatelet drugs orally.\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, or QTc interval (calculated via Bazett's formula using manually collected screening data) \\>470ms in females or \\>450ms in males.\n  4. Refractory hypertension (blood pressure not controlled despite ≥1 month of optimal, tolerable doses of 2 or more antihypertensive drugs \\[including diuretics\\] with lifestyle modifications; or blood pressure controlled only with 3 or more antihypertensive drugs).\n* Active bleeding within 2 months prior to screening; use of anticoagulants\u002Fantiplatelet drugs for \\\u003C6 months; or a definite bleeding tendency as judged by the investigator (e.g., bleeding-risk esophageal varices, active local ulcer lesions).\n* Diabetic patients whose blood sugar remains poorly controlled after insulin treatment\n* A history of stroke or intracranial hemorrhage within 6 months prior to screening, excluding postoperative sequelae-related intracranial hemorrhage\n* A history of organ transplantation or allogeneic bone marrow transplantation\n* Surgical procedures within 6 weeks prior to screening (diagnostic examinations are not considered surgical procedures; insertion of vascular access devices is exempt from this exclusion criterion).\n* Use of Chinese herbal medicines with anti-tumor effects (as specified in the package insert, e.g., Compound Cantharidin Capsules) within 4 weeks prior to screening\n* Active or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and\u002For HBcAb positive with positive HBV DNA titer); HCV Ab positive; HIV positive. The following patients can be provisioned for continuous observation pending enrollment when given prophylactic anti-HBV (such as entecavir or tenofovir), including :\n\n  1. HBsAg positive with negative HBV DNA titer.\n  2. HBsAg negative, HBsAb negative, HBcAb positive, and negative HBV DNA titer Patients with positive HBV-DNA can be considered for enrollment only when the HBV-DNA value is less than 500IU\u002FmL after treatment\n* Uncontrolled active systemic fungal, bacterial, viral, or other infections (defined as persistent infection-related symptoms\u002Fsigns that do not improve despite appropriate antibiotic or other treatments) or requiring intravenous antibiotics\n* Administration of live vaccines or immunological agents within 4 weeks prior to enrollment.\n* Need for concurrent and continuous use of drugs with moderate\u002Fstrong inhibitory or inductive effects on cytochrome P450 CYP3A.\n* Patients with hypersensitivity to orelabrutinib or its excipients (e.g., immediate or accelerated allergic reactions).\n* Patients with hypersensitivity to teniposide or its excipients (e.g., immediate or accelerated allergic reactions)\n* Clinically significant gastrointestinal abnormalities that may affect drug intake, transit, or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or participants with total gastrectomy.\n* Participants with a history or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia with severely impaired lung function, etc\n* Participants with chronic liver damage, severe fatty liver, or alcoholic liver disease.\n* Pregnant or lactating women; women of childbearing age who are unwilling to use contraception from the time of enrollment until 180 days after the last dose of the study drug (serum pregnancy test results must be negative within 14 days before the start of study drug treatment for women of childbearing potential); men who are not surgically sterilized and unwilling to use contraception during the study and until 180 days after the last dose of the study drug.\n* Presence of life-threatening diseases or severe organ dysfunction, deemed unsuitable for participation in the trial by the investigator.\n* Any mental or cognitive impairment that may limit the understanding and execution of the informed consent form or adherence to the study\n* Previous receipt of whole-brain radiotherapy for primary central nervous system lymphoma.","75 Years",{"count":262,"type":20},215,[65,264],"PHASE3","This is a three-arm, multicenter, randomized controlled trial. Eligible participants will be randomized to one of three induction regimens via stratified block randomization at a 2:2:1 ratio.\n\nInduction regimens:\n\nArm A: Teniposide + orelabrutinib + rituximab + methotrexate (MTX) + dexamethasone, administered in 21-day cycles.\n\nArm B: Orelabrutinib + rituximab + MTX + dexamethasone, administered in 21-day cycles.\n\nArm C: Rituximab + MTX + dexamethasone, administered in 21-day cycles. Participants achieving complete response (CR) or unconfirmed complete response (CRu) post-induction will proceed to consolidation therapy, with options including: MTX + rituximab (once every 3 months for 1 year); high-dose chemotherapy followed by autologous stem cell transplantation (ASCT); dose-reduced whole brain radiotherapy; or other modalities (as determined by the investigator).",[27],"2025-09-15",{"date":269,"type":46},"2025-09-22",{"date":271,"type":20},"2025-10-01",{"date":273,"type":20},"2029-07-30",{"name":275,"class":52},"Huashan Hospital",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":130},"100432052","phase-2-paxalisib-gdc-0084-in-recurrent-or-refractory-pcnsl-100432052","NCT04906096","Paxalisib (GDC-0084) In Recurrent Or Refractory PCNSL","A Phase 2 Study of Paxalisib (GDC-0084) in Recurrent or Refractory Primary Central Nervous System Lymphoma (PCNSL)","Inclusion Criteria:\n\n* Participants must be able to understand and willing to sign a written informed consent document.\n* Participant must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.\n* Participants must be at least 18 years old on day of signing informed consent.\n* Participants must have a Karnofsky Performance Status (KPS) ≥ 70\n* Participants must have histologically confirmed R\u002FR primary DLBCL CNS lymphoma (from brain biopsy, CSF or vitreous biopsy).\n* Participants should have evidence of refractory or recurrent disease on MRI with measurable or evaluable enhancing disease.\n* Participants must have recovered to ≤ grade 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy; exception, participants with ≤ grade 2 neuropathy may be eligible.\n* Participant with dexamethasone requirement of ≤ 8mg\u002Fday or bioequivalent with corticosteroid usage at a stable or decreasing dose 2 weeks prior to screening.\n* Participants must be able to undergo MRI.\n* Participants must demonstrate adequate as defined below (all screening labs should be performed within 14 days of treatment initiation):\n\n  * Hematology\n\n    * White Blood Count (WBC) ≥ 2 K\u002FµL\n    * Platelet count ≥ 100 K\u002FµL\n    * Absolute Neutrophil Count ≥ 1.5 K\u002FµL\n    * Hemoglobin \\> 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks)\n  * Biochemistry\n\n    * Serum creatinine ≤1.5 x institutional ULN OR Measured or calculated creatinine clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN (Creatinine clearance should be calculated per institutional standard)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤5 × ULN for participants with liver metastases)\n    * Total bilirubin (TBILI) ≤ 1.5 x institutional ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level of \\\u003C 3.0 x institutional ULN) OR Direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN)\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy within 72 hours prior to registration.\n* WOCBP who are sexually active must use highly effective methods of contraception during treatment and for 28 days after the last dose of paxalisib. For male subjects with a pregnant or non-pregnant WOCBP partner, contraception measures are required during treatment and for 28 days after the last dose of paxalisib.\n\nThe subject, in consultation with the investigator, will select the most appropriate method of contraception from the permitted list of contraception methods, and site personnel will instruct the subject in its consistent and correct use as needed.\n\nIn addition, the investigator will instruct the subject to notify the site immediately if pregnancy of the subject or their partner is known or suspected.\n\nHighly effective methods of contraception are those that, alone or in combination, result in a failure rate of less than 1% per year when used consistently and correctly and include:\n\n* Established use of oral, injected, or implanted hormonal methods of contraception\n* Correctly placed intrauterine device (IUD) or intrauterine system (IUS)\n* Male condom or female condom used WITH a spermicide (i.e., foam, gel, film, cream)\n* Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate\n* Bilateral tubal ligation or bilateral salpingectomy\n\nExclusion Criteria:\n\n* Participants unable to undergo MRI brain.\n* Participants with active systemic disease.\n* Participants with uncontrolled intercurrent illness.\n* Participants with prior exposure to mTOR\u002FPI3K inhibitors\n* Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, superficial bladder cancer or other cancer from which the subject has been disease free for ≥ 3 years.\n* Participants who have received prior systemic anti-cancer therapy including investigational agents or radiotherapy within 4 weeks OR 5 half-lives prior to dosing, whichever is shorter. Note: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.\n* Participants who have difficulty with or are unable to swallow oral medication or have significant gastrointestinal disease that would limit absorption of oral medication.\n* Known history of infection with HIV, prior history of PML or any active significant infection (eg, bacterial, viral, or fungal).\n* Known history of hypersensitivity or anaphylaxis to paxalisib including active product or excipient components.\n* Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor\u002Finducer which may have an effect of the metabolism of paxalisib.\n* Participants with uncontrolled medical comorbidities per investigator discretion including but not limited to interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, pre-exisiting Crohn's disease or ulcerative colitis or pre-existing chronic condition resulting in baseline grade 2 or higher diarrhea.\n* Participants with type I diabetes mellitus, participants with uncontrolled type II diabetes mellitus,despite being on oral anti-diabetic medication. , participants with Type II diabetes mellitus that are well controlled on insulin . Uncontrolled diabetes is defined as HbA1c \\>9% in addition to fasting glucose\\>140mg\u002FdL on at least 2 occasions within 14 days prior to registration\n* Participants with uncontrolled hypertension despite optimal medical management (per investigator's assessment).\n* Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo DNA PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result to be eligible. Those who are hepatitis C PCR positive will be excluded.\n* Breast feeding or pregnant\n* Concurrent participation in another therapeutic trial.",{"count":284,"type":20},25,[65],"This research study is studying a drug called Paxalisib (GDC-0084) as a possible treatment for primary central nervous system lymphoma (PCNSL)",[27,288],"Non-Hodgkin Lymphoma of Extranodal Site",[27,288],"2025-06-23",{"date":292,"type":46},"2025-06-26",{"date":294,"type":46},"2021-06-01",{"date":296,"type":20},"2027-12-01",{"name":298,"class":52},"Lakshmi Nayak, MD",{"id":300,"slug":301,"hasResults":11,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":21,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":320},"100529532","phase-2-maintenance-obinutuzumab-in-treating-patients-with-central-nervous-system-lymphoma-who-have-achieved-a-complete-or-partial-response-100529532","NCT06175000","Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response","Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete or Partial Responders","Inclusion Criteria:\n\n* CD20+ B-cell primary central nervous system lymphoma (PCNSL) confirmed at the time of diagnosis by histology, cytology, or immunocytochemistry from cerebrospinal fluid (CSF); diagnosis must be documented by pathology report.\n* Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as \\>= 3 grams\u002Fm\\^2; methotrexate dose reduction for creatinine clearance \\\u003C 100 ml\u002Fmin is permitted\n* Must be within 75 days of completion of first-line treatment regimen at the time of randomization; must have achieved objective response (PR or CR\u002Funconfirmed complete response \\[CRu\\]) to first-line treatment\n* Brain magnetic resonance imaging (MRI) documenting objective response must be obtained within 30 days before randomization\n* If CSF was positive for lymphoma cells at diagnosis or during first-line treatment and\u002For a slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; Note: CR requires complete disappearance of all enhancing abnormalities on gadolinium-enhanced MRI; if CSF was positive for lymphoma cells at diagnosis or during first-line treatment and\u002For slit lamp examination was positive at diagnosis or during first-line treatment, then the CSF and vitreal studies must have been repeated and must have indicated CR; for CRu, some patients will have a small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; it is often difficult to ascertain whether this represents a residual nidus of tumor or scar tissue; if the abnormality does not change or slowly involutes without therapy and corticosteroids, it is reasonable to categorize as a CRu; at the time CR\u002FCRu is determined, the patient should not have used corticosteroids for at least two weeks\n* Karnofsky performance status (KPS) \\>= 60; Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2\n* Signed informed consent form (ICF)\n* Ability and willingness to comply with the requirements of the study protocol\n* Total bilirubin \\\u003C 3 x the upper limit of normal (ULN), ≤ 7 days before date of randomization\n* Creatinine clearance \\> 30 mL\u002Fmin (calculated according to institutional standards or using Cockcroft-Gault formula), ≤ 7 days before date of randomization\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 5 x ULN, ≤7 days before date of randomization\n* Platelet ≤ 75,000 cells\u002Fmm\\^3, ≤ 7 days before date of randomization\n* Hemoglobin \\> 9 g\u002FdL, ≤ 7 days before date of randomization\n* Absolute neutrophil count \\> 1.5 x 10\\^3 cells\u002Fmm\\^3, ≤ 7 days before date of randomization\n* Surgically sterile or agree to use effective contraception using an adequate measure of contraception such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly while receiving obinutuzumab and \\>= 18 months after the last dose of obinutuzumab for women, and 180 days after the last dose of obinutuzumab for men\n\nExclusion Criteria:\n\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy\n* Clinical evidence of extra-central nervous system (CNS) (systemic) non-Hodgkin lymphoma\n* Known hypersensitivity to any of the study drugs\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for \\>= 2 years prior to randomization\n* Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (related to the completion of the course of antibiotics) within 4 weeks prior to study randomization\n* Major surgery within 4 weeks prior to study randomization\n* Known infection with human immunodeficiency virus (HIV)\n* Positive hepatitis serologies:\n* Hepatitis B (HBV): patients with positive serology for hepatitis B defined as positivity for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (anti-HBc); patients who are positive for anti-HBc may be considered for inclusion in the study on a case-by-case basis if they are hepatitis B viral deoxyribonucleic acid (DNA) negative and are willing to undergo ongoing HBV DNA testing by real-time polymerase chain reaction (PCR); patients with positive serology may be referred to a hepatologist or gastroenterologist for appropriate monitoring and management\n* Hepatitis C (HCV): patients with positive hepatitis C serology unless HCV ribonucleic acid (RNA) is confirmed negative and may be considered for inclusion in the study on a case-by-case basis\n* Women who are pregnant or lactating\n* Vaccination with a live vaccine a minimum of 4 weeks prior to study randomization",{"count":307,"type":20},28,[65],"This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.",[27],"2025-06-04",{"date":313,"type":46},"2025-06-05",{"date":315,"type":46},"2024-03-13",{"date":317,"type":20},"2029-09-15",{"name":319,"class":52},"Providence Health & Services",7,{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":21,"phases":331,"briefSummary":332,"conditions":333,"keywords":334,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":107},"100419143","phase-2-rituximab-lenalidomide-combined-with-methotrexate-and-temozolomide-for-primary-central-nervous-system-lymphoma-100419143","NCT04737889","Rituximab, Lenalidomide Combined With Methotrexate and Temozolomide For Primary Central Nervous System Lymphoma","A Single Arm, Multi-center, Phase II Clinical Trial of Rituximab, Lenalidomide Combined With High-dose Methotrexate and Temozolomide (RL-MT) in the First-line Treatment for Patients With Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Age between 18 to 70 years old (including 18 and 70)\n2. Diagnosed as primary central nervous system lymphoma (limited to the brain, spinal cord, meninges and eyeballs, without involvement of other parts)\n3. Having not received anti-tumor therapy before enrollment (except for tumor resection and biopsy and the use of glucocorticoids to reduce central nervous system symptoms)\n4. Having at least one measurable lesions\n5. 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)\n6. Life expectancy no less than 1 month\n7. enough main organ function\n8. 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\n9. Agreeing to sign the written informed consents\n\nExclusion Criteria:\n\n1. Diagnosed as secondary central nervous system lymphoma\n2. Diagnosed as CD20 negative large B cell primary central nervous system lymphoma\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","70 Years",{"count":330,"type":20},30,[65],"This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of Rituximab, Lenalidomide combined with high-dose Methotrexate and Temozolomide (RL-MT) in the first-line treatment for patients with primary central nervous system lymphoma.",[27],[27,335],"RL-MT","2025-04-18",{"date":338,"type":46},"2025-04-23",{"date":340,"type":46},"2021-01-13",{"date":342,"type":20},"2026-01-13",{"name":344,"class":345},"Henan Cancer Hospital","OTHER_GOV",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":21,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":107},"100588391","phase-2-tirabrutinib-maintenance-versus-placebo-in-patients-with-primary-cns-lymphoma-in-complete-remission-jcog2104-100588391","NCT06940791","Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)","Tirabrutinib Maintenance Versus Placebo in Patients With Primary Central Nervous System Lymphoma in Complete Remission: a Randomized Phase II Study (JCOG2104)","TIMELY-pII","Inclusion Criteria:\n\n1. Histopathological diagnosis of B cell lymphoma.\n2. Newly-diagnosed PCNSL confined to the cerebrum, cerebellum and brainstem. Patients with or without interocular lymphoma are eligible.\n3. Negative cerebrospinal fluid (CSF) cytology, or no evidence of leptomeningeal lymphomatosis in contrast-enhanced magnetic resonance imaging (MRI) of the brain and the whole spinal cord.\n4. No evidence of systemic lymphoma before induction chemotherapy, confirmed by contrast-enhanced CT including the neck, chest, abdomen, pelvic cavity and groin, or whole-body positron-emission tomography (PET) and CT.\n5. Patients with a single lesion, or multiple lesions, are eligible.\n6. Patients 18 years old or older at the time of registration.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1, 2.\n8. Have completed either of the following methotrexate (MTX)-based chemotherapy i) R-MPV (rituximab, MTX, procarbazine and vincristine) ii) MPV (MTX, procarbazine and vincristine) iii) R-MP (rituximab, MTX and procarbazine) iv) MP (MTX and procarbazine) v) R-M (rituximab and MTX) vi) MTX monotherapy\n9. Complete response (CR) or complete response unconfirmed (CRu) based on the International PCNSL Collaborative Group (IPCG) criteria.\n10. Within 60 days from the last dose of induction or consolidation chemotherapy.\n11. No treatment history of radiotherapy for PCNSL.\n12. Refused to receive consolidation radiotherapy.\n13. No treatment history of chemotherapy or radiotherapy, except for stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) for non-cancer diseases (such as arteriovenous malformations).\n14. Adequate organ function. i) Neutrophil count \\>=1,000\u002Fmm3 ii) Hemoglobin \\>= 8.0 g\u002Fdl iii) Platelet count \\>= 75,000\u002Fmm3 iv) AST \\\u003C=120 U\u002FL v) ALT \\\u003C= 120 U\u002FL vi) Total Bilirubin \\\u003C= 2.25 mg\u002Fdl vii) Creatinine \\\u003C= 1.5 mg\u002FdL\n15. Written informed consent.\n\nExclusion Criteria:\n\n1. Synchronous or metachronous malignancies.\n2. Infections requiring systemic treatment at the time of registration.\n3. Body temperature \\>=38 degree celsius at the time of registration.\n4. Serious lung disorders, such as interstitial pneumonia, obstructive lung disease, hypersensitive pneumonitis, symptomatic bronchospasm) at the time of registration.\n5. History or presence of aspergillus pneumonitis or pneumocystis pneumonia.\n6. History of serious drug allergy or serious anaphylaxis.\n7. Heart failure (\\>= III in New York Heart Association functional classification), unstable angina pectoris, or history of myocardial infarction within the preceding 180 days prior to registration.\n8. Treated by anticoagulants at the time of registration.\n9. Treated by antiplatelets at the time of registration.\n10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).\n11. Immune deficiency, such as acquired immunodeficiency syndrome (AIDS), X-linked agammaglobulinemia, chronic granulomatous disease, Wiskott-Aldrich syndrome, or any other iatrogenic immunosuppressive conditions.\n12. Post organ transplant immunosuppression.\n13. Prednisone use of \\>10 mg\u002Fday for condition other than intracranial tumor, or regular use of immunosuppressants.\n14. Uncontrolled diabetes mellitus.\n15. Treated either by CYP3A4 inhibitors, CYP3A4 inducers, or P-gp inducers within 14 days prior to registration.\n16. Gadolinium allergy.\n17. Positive HIV antibody.\n18. Positive HBs antigen.\n19. Positive HBs antibody or HBc antibody, and HBV-DNA positive.\n20. Positive HCV antibody.\n21. Unable to take oral medicine,\n22. Females during pregnancy, or within 28 days postpartum, or during lactation. Males who wish childbearing of his partner.\n23. Prior history of treatment by BTK inhibitors.\n24. Severe psychiatric disorders.",{"count":355,"type":20},92,[65],"A double-blind, randomized phase II comparative trial will evaluate the superiority of the investigational treatment (tirabrutinib maintenance therapy) over standard care (observation with placebo) in terms of progression-free survival in patients with newly diagnosed primary central nervous system lymphoma (PCNSL) who have achieved complete response (CR or CRu) following induction therapy with high-dose methotrexate (HD-MTX)-based chemotherapy and have not undergone consolidative whole-brain irradiation.\n\nParticipants will:\n\nTake protocol drug tirabrutinib or a placebo every day until disease progression or experience of unacceptable toxicity.\n\nVisit the clinic once every 4 weeks for checkups and tests, as well as protocol drug prescription.",[27],"2025-04-15",{"date":338,"type":46},{"date":362,"type":46},"2023-10-06",{"date":364,"type":20},"2030-02",{"name":366,"class":52},"Kyorin University",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":374,"targetDuration":4,"studyType":21,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":107},"100580051","rituximab-methotrexate-temozolomide-thiotepa-rmtt-regimen-as-first-line-therapy-for-pcns-dlbcl-100580051","NCT06832267","Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL","A Single-center, Single-arm Phase II Trial of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for Primary Central Nervous System Diffuse Large B-cell Lymphomas(PCNS DLBCL)","Inclusion Criteria:\n\n* Patients voluntarily joined the study, signed the informed consent, and had good compliance;\n* Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-3;\n* Patients with histopathologically confirmed newly diagnosed primary central nervous system diffuse large B-cell lymphoma, and there were intracranial evaluable lesions (long diameter greater than 1.5cm, short diameter greater than 1cm);\n* Patients who have not received any systemic therapy, except those who use hormones to control complications\n* Expected survival of more than 3 months.\n* Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study.\n\nExclusion Criteria:\n\n* Patients who have previously received antitumor therapy or targeted therapy\n* Patients who have undergone major surgery within the past 3 weeks .\n* Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.\n* Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.\n* Patients who are pregnant or breastfeeding.\n* Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment.\n* Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.",{"count":375,"type":20},44,[162],"This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)",[27],"2025-02-12",{"date":381,"type":46},"2025-02-18",{"date":383,"type":20},"2025-02-14",{"date":385,"type":20},"2028-02-13",{"name":387,"class":52},"Zhejiang Cancer Hospital",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":16,"minAge":396,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":21,"phases":399,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":417},"100579909","phase-3-adjusted-high-dose-chemotherapy-with-autologous-stem-cell-transplant-vs-conventional-immunochemotherapy-in-elderly-pcnsl-patients-100579909","NCT06830421","Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients","Age-adjusted High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation or Conventional Chemotherapy With R-MP as First-line Treatment in Elderly Primary CNS Lymphoma Patients - a Randomized Phase III Trial","PRIMA-CNS","Inclusion Criteria:\n\n1. Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system.\n2. Age \\> 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial).\n3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist.\n4. Diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (CSF) cytology examination or vitrectomy.\n5. Disease exclusively located in the CNS.\n6. At least 1 measurable lesion.\n7. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) ≤ 2. ECOG PS \\> 2 accepted if due to PCNSL symptoms.\n8. Patients possibly eligible for HCT-ASCT as judged by the treating physician.\n9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease.\n\nAdditional randomization criteria:\n\n1. Patients eligible for HCT-ASCT defined by the EBL score (at most one of the 3 following conditions may apply: ECOG PS \\> 1, Barthel Index of activities of daily living (ADL) \\\u003C 20 and Lachs geriatric screening \\> 3), improvement of PS after pre-phase treatment or clinical judgement by the treating physician after discussion with the study expert team.\n2. No evidence of disease progression after pre-phase treatment.\n\nExclusion Criteria:\n\n1. Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation.\n2. Systemic lymphoma manifestation (outside the CNS).\n3. Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord.\n4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in situ or other kinds of cancer without evidence of disease for at least 5 years.\n5. Previous systemic Non-Hodgkin lymphoma at any time.\n6. Inadequate renal function (creatinine clearance \\\u003C60 ml\u002Fmin).\n7. Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision.\n8. Active hepatitis B or C disease.\n9. Concurrent treatment with other experimental drugs or participation in an interventional clinical trial with administration of study medication within the last thirty days before the start of this study.\n10. Third space fluid accumulation \\>500 ml.\n11. Hypersensitivity to study treatment or any component of the formulation.\n12. Taking any medications likely to cause interactions with the study medication.\n13. Known or persistent abuse of medication, drugs or alcohol.\n14. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic.\n15. Patients without legal capacity and who are unable to understand the nature, significance and consequences of the study and without designated legal representative.\n16. Previous participation in this trial.\n17. Persons who are in a relationship of dependency\u002Femployment to the sponsor and\u002F or investigator.\n18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n19. Fertile patients refusing to use safe contraceptive methods during the study.","65 Years",{"count":398,"type":20},340,[264],"Most patients being diagnosed with primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) are 60 years or older. Elderly patients with PCNSL have a poor prognosis and there is a great medical need to improve outcome for this vulnerable population. In Germany and many international centres, there are currently two widely used strategies to treat elderly PCNSL patients who are eligible for high-dose methotrexate (HD-MTX) treatment, which have not yet been compared head-to-head. The R-MP regimen has been established by the Cooperative PCNSL Study Group as a \"conventional\" immunochemotherapy standard treatment for elderly patients with newly diagnosed disease and consists of Rituximab, HD-MTX and Procarbazine followed by maintenance therapy with Procarbazine. In contrast, another recently established protocol also includes HD-MTX-based induction therapy, but followed by consolidating high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT). This is an overall more intensive, but substantially shorter treatment approach, feasible for elderly patients being considered eligible for a more intensive treatment. The PRIMA-CNS trial aims to compare these two treatment approaches with respect to survival, response rates and toxicity.",[27],[403,404,405,406,407],"Primary central nervous system lymphoma","HD-chemotherapy followed by autologous stem cell transplantation","Age-adjusted HCT-ASCT","First-line treatment in elderly PCNSL patients","HD-MTX induction","2025-02-11",{"date":410,"type":46},"2025-02-17",{"date":412,"type":46},"2023-08-09",{"date":414,"type":20},"2031-08-31",{"name":416,"class":52},"University Hospital Freiburg",35,{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":21,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":107},"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":417,"type":20},[23,65],"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.",[429,27,31],"CNS Lymphoma","2025-01-30",{"date":432,"type":46},"2025-02-03",{"date":434,"type":46},"2022-06-08",{"date":436,"type":20},"2026-06-30",{"name":438,"class":52},"James Rubenstein",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":21,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":107},"100367880","phase-2-camrelizumab-for-patients-with-recurrent-primary-central-nervous-system-lymphoma-pcnsl-100367880","NCT04070040","Camrelizumab for Patients with Recurrent Primary Central Nervous System Lymphoma (PCNSL)","An Exploratory Study on Camrelizumab（SHR-1210）for Recurrent Primary Central Nervous System Lymphoma (PCNSL)","Inclusion Criteria:\n\n1. The initial diagnosis was primary diffuse large B-cell lymphoma of the central nervous system confirmed by histopathology;\n2. Prior to first-line treatment based on methotrexate (with or without radiotherapy), tumor recurrence was confirmed by MRI;\n3. Measurable focus in MRI (\\>10x10mm);\n4. Aged \\> 18 years;\n5. Life expectancy of at least 12 weeks;\n6. The patient has a Karnofsky performance status of at least 50%;\n7. Main organs function normally, without serious blood, heart, lung, liver, kidney and immune deficiency diseases. Specific assay indicators requirements： White blood cells\\>3.0×10\\^9\u002FL;platelet\\>80×10\\^9\u002FL;hemoglobin\\>10g\u002FdL;serum bilirubin ≤ 1.5×ULN;ALT and AST ≤ 2×ULN;serum creatinine≤1.5mg\u002FdL;\n8. Female subjects of childbearing age must exclude pregnancy and are willing to use a medically approved high-efficiency contraceptive (eg, IUD, contraceptive or condom) during the study period and within 3 months of the last study drug administration;\n9. The subject should be aware of the purpose of the study and the operations required by the study and volunteer to participate in the study before sign the informed consent form;\n\nExclusion Criteria:\n\n1. Concurrent administration of any other antitumor therapy；\n2. Allergic to the ingredients of research drugs；\n3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent；\n4. Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, decreased thyroid function；\n5. Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except for a maximum dose of 4 mg\u002Fday dexamethasone or equivalent doses of other corticosteroids or control of brain edema, which has been stable or decreased for at least 1 week prior to inclusion;\n6. Active infection;\n7. Risk of bleeding;\n8. HIV positivity;\n9. Pregnancy and lactation;",{"count":5,"type":20},[65],"This study is intend to improve the objective response rate in treatment of camrelizumab in recurrent primary central nervous system lymphoma patients.",[27],"2024-10-09",{"date":452,"type":46},"2024-10-15",{"date":454,"type":46},"2020-02-13",{"date":456,"type":20},"2024-12-31",{"name":458,"class":52},"Beijing Sanbo Brain Hospital",{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":466,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":107},"100485406","phase-2-orelabrutinibrituximab-and-methotrexate-in-newly-diagnosed-primary-central-nervous-system-lymphoma-100485406","NCT05600660","Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma","Orelabrutinib, Rituximab and Methotrexate (OR-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma: a Single Arm, Multicenter, Phase 2 Study","Inclusion Criteria:\n\n1. Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range 18-75 years old.\n2. Eastern Cooperative Oncology Group performance status 0 to 3.\n3. Previously untreated. Patients treated with steroid alone are eligible.\n4. Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.\n5. Life expectancy of ≥ 3 months (in the opinion of the investigator).\n6. Participants must be able to understand and be willing to sign a written informed consent document.\n7. Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months 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 6 months after the last dose.\n\n   Women of childbearing potential must have a negative plasma pregnancy test upon study entry.\n8. Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin;Serum creatinine ≤ 2 times the upper limit of normal.\n9. Adequate liver functions: Transaminase (AST\u002FALT) \\\u003C 3 X upper normal value \\& Bilirubin \\\u003C 2 X upper normal value.\n10. Adequate hematological function: hemoglobin ≥ 9 g\u002FdL absolute neutrophil count (ANC) ≥ 1,500\u002FμL and platelet count ≥ 75,000\u002FμL.\n11. Must be able to tolerate lumbar puncture and MRI\u002FCT.\n12. Ability to swallow oral medications.\n\nExclusion Criteria:\n\n1. Patient with systemic, non-CNS lymphoma metastatic to the CNS.\n2. Patient is concurrently using other approved or investigational antineoplastic agents.\n3. Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.\n4. Patient is allergic to components of the study drug.\n5. Patient has an active concurrent malignancy requiring active therapy.\n6. Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.\n7. Patient is known to have an uncontrolled active systemic infection.\n8. 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.\n9. 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 plasma human chorionic gonadotropin(hCG) laboratory test of \\> 5 mIU\u002FmL.\n10. The patient is unwell or unable to participate in all required study evaluations and procedures.\n11. Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results.\n12. History of intracranial hemorrhage or clinically significant stroke within 6 months prior to first day of study treatment\n13. History of significant gastrointestinal disease that would limit absorption of oral medications.\n14. Warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Use of low molecular weight heparin and novel oral anticoagulants (eg. rivaroxaban, apixaban) is permitted if required.\n15. Concurrent use of a moderate or strong inhibitor or inducer of the P450 isoenzyme CYP3A. Participants must be off P450\u002FCYP3A inhibitors and inducers prior to starting the study drug.\n16. Known bleeding diathesis (e.g. von Willebrand's disease), hemophilia, or active bleeding.\n17. History of invasive fungal infection, including invasive aspergillosis, or known active tuberculosis.\n18. Patients considered unsuitable to participate in the study by the researchers.",{"count":307,"type":20},[65],"It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, Rituximab and Methotrexate）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.",[27],[27,471,69,472],"Orelabrutinib","Lenalidomide","2022-11-03",{"date":475,"type":46},"2022-11-08",{"date":477,"type":46},"2022-08-01",{"date":479,"type":20},"2027-12-31",{"name":481,"class":52},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":489,"targetDuration":4,"studyType":21,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":4},"100465970","phase-2-penpulimab-combined-with-rma-treatment-of-primary-diagnosis-of-primary-central-nervous-system-lymphoma-100465970","NCT05347641","Penpulimab Combined With RMA Treatment of Primary Diagnosis of Primary Central Nervous System Lymphoma","A Single-arm, Prospective, Single-center, Phase II Clinical Study of Penpulimab Combined With RMA in the Treatment of Newly Diagnosed Primary CNS Lymphoma","Inclusion Criteria:\n\n* For initial PCNSL confirmed by pathological tissue, the diagnostic criteria were based on WHO diagnostic criteria in 2016\n* Head MR (plain scan + enhancement) performed 28 days prior to study enrollment should show the presence of at least one measurable lesion in two vertical directions (according to 2014 Lugano criteria); Or abnormal cerebrospinal fluid examination (including cerebrospinal fluid protein, cells, NGS), or ophthalmologic examination confirmed the retina, vitreous lesions\n* PS score was 0\\~4 according to ECOG\n\nExclusion Criteria:\n\n* Organs or lymph nodes outside the central nervous system are involved\n* Patients with a second primary tumor (other than non-melanoma skin cancer in situ, superficial bladder cancer, cervical cancer in situ, gastrointestinal intramucosal cancer or breast cancer that has been cured and has not recurred within 5 years)\n* Has a history of allergic disease, severe drug allergy, or is known to be allergic to any component of a macromolecular protein preparation or penpulimab injection prescription\n* Prior treatment with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CTLA-4 antibody, or CAR T cell therapy (or any other antibody that acts on T cell co-stimulation or checkpoint pathways)\n* A severe acute or chronic infection requiring systemic treatment\n* The investigator believes that the subjects may have other factors that affect the efficacy or safety evaluation of the study",{"count":490,"type":20},23,[65],"To explore PFS, ORR (CR\u002FCRu+PR), OS and side effects of piamprizumab combined with RMA in newly diagnosed PCNSL, so as to clarify the value of piamprizumab combined with RMA in the first-line treatment of PCNSL patients, and to clarify the clinical and biological factors affecting the efficacy",[27],"2022-04-20",{"date":496,"type":46},"2022-04-26",{"date":498,"type":20},"2022-06-01",{"date":500,"type":20},"2029-06-01",{"name":502,"class":52},"The First Affiliated Hospital with Nanjing Medical University",{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":16,"minAge":510,"maxAge":260,"enrollmentInfo":511,"targetDuration":4,"studyType":21,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":107},"100273204","phase-2-therapeutic-effects-of-r-idaram-and-intrathecal-immunochemotherapy-on-elderly-patients-with-pcnsl-100273204","NCT02836158","Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With PCNSL","Therapeutic Effects of R-IDARAM and Intrathecal Immunochemotherapy on Elderly Patients With Primary CNS Lymphoma","Inclusion Criteria:\n\n* Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).\n\nExclusion Criteria:\n\n* Involved sites other than the brain, meninges, CSF, or the eyes.\n* Age less than 18 years or greater than 75 years.\n* Inadequate bone marrow capacity (defined as neutrophils\\\u003C1.5 ×10\\^9\u002FL, platelets \\\u003C100 ×10\\^9\u002FL, and hemoglobin level\\\u003C 8 g\u002FdL).\n* Known cause of immunosuppression (ie, HIV type I infection).\n* Any previous malignancy.\n* Creatinine clearance below 60 mL\u002Fmin.\n* Heart insufficiency (NYHA IIIB or IV).\n* Uncontrolled infection.\n* Noncompensated active pulmonary or liver disease.\n* Previously treated for PCNSL, except by corticosteroids.","60 Years",{"count":512,"type":20},100,[65,264],"This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in elderly patients with primary central nervous system lymphoma (PCNSL).",[27],"2020-09-08",{"date":518,"type":46},"2020-09-09",{"date":520,"type":4},"2010-09",{"date":522,"type":20},"2030-12",{"name":524,"class":52},"Navy General Hospital, Beijing",{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":260,"enrollmentInfo":532,"targetDuration":4,"studyType":21,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":538,"leadSponsor":539,"locationsCount":107},"100259548","phase-2-treatment-of-pcnsl-with-r-idaram-and-intrathecal-immunochemotherapy-100259548","NCT02657785","Treatment of PCNSL With R-IDARAM and Intrathecal Immunochemotherapy","Treatment of Primary CNS Lymphoma With Systemic R-IDARAM Chemotherapy and Intrathecal Immunochemotherapy","Inclusion criteria:\n\n* Newly diagnosed histologically proven non-Hodgkin's lymphoma (NHL).\n\nExclusion criteria:\n\n* Involved sites other than the brain, meninges, CSF, or the eyes.\n* Age less than 18 years or greater than 75 years.\n* Inadequate bone marrow capacity (defined as neutrophils\\\u003C1.5 ×10\\^9\u002FL, platelets \\\u003C100 ×10\\^9\u002FL, and hemoglobin level\\\u003C 8 g\u002FdL).\n* Known cause of immunosuppression (ie, HIV type I infection).\n* Any previous malignancy.\n* Creatinine clearance below 60 mL\u002Fmin.\n* Heart insufficiency (NYHA IIIB or IV).\n* Uncontrolled infection.\n* Noncompensated active pulmonary or liver disease.\n* Previously treated for PCNSL, except by corticosteroids.",{"count":512,"type":20},[65,264],"This study suggests that R-IDARAM combined with intrathecal immunochemotherapy may be high effective in primary central nervous system lymphoma (PCNSL) patients.",[27],{"date":518,"type":46},{"date":520,"type":4},{"date":522,"type":20},{"name":524,"class":52}]