[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-central-nervous-system-lymphoma-pcnsl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-central-nervous-system-lymphoma-pcnsl":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,59,95,126,154,180,204,228,253,276,301],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100449326","phase-1-a-study-of-nx-5948-in-adults-with-relapsedrefractory-b-cell-malignancies-100449326",false,"NCT05131022","A Study of NX-5948 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Patients in Phase 1a (Dose Escalation) must have histologically confirmed R\u002FR CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and\u002For BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.\n* Patients in Phase 1a must meet the following:\n\n  o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy\n* Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and\u002For molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL\u002FSCNSL.\n* Measurable disease per response criteria specific to the malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment\n* Prior treatment for the indication under study for anti-cancer intent that includes:\n\n  1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).\n  2. Prior systemic chemotherapy within 2 weeks of planned start of study drug.\n  3. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.\n  4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.\n  5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.\n  6. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).\n  7. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL\u002FSCNSL: no greater than 40 mg\u002Fday prednisone, or equivalent. Patients with PCNSL\u002FSCNSL using greater than 20 mg\u002Fday prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg\u002Fday prednisone or equivalent.\n  8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug\n  9. Previously treated with a BTK degrader\n* Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.\n* Patient has any of the following within 6 months of planned start of study drug:\n\n  1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent\n  2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure\n  3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage\n  4. Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg despite optimal medical management)\n* Bleeding diathesis, or other known risk for acute blood loss.\n* History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.\n* Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).","ALL","18 Years",{"count":19,"type":20},572,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.",[26,27,28,29,30,31,32,33,34],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)","Diffuse Large B Cell Lymphoma (DLBCL)","Follicular Lymphoma (FL)","Mantle Cell Lymphoma (MCL)","Marginal Zone Lymphoma (MZL)","Waldenstrom Macroglobulinemia (WM)","Primary Central Nervous System Lymphoma (PCNSL)","Secondary Central Nervous System Lymphoma (SCNSL)",[36,37,38,39,40,41,42,43,44,45],"BTK Degrader","BTK Inhibitor","B-Cell Malignancy","Lymphoma","C481","C481S","Bruton's Tyrosine Kinase","NX-5948","Targeted Protein Degradation","Chimeric Targeting Molecule (CTM)","RECRUITING","2026-06-30",{"date":49,"type":50},"2026-07-02","ACTUAL",{"date":52,"type":50},"2022-04-13",{"date":54,"type":20},"2028-01",{"name":56,"class":57},"Nurix Therapeutics, Inc.","INDUSTRY",62,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":76,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100599313","phase-1-a-study-of-epcoritamab-and-ibrutinib-in-people-with-central-nervous-system-lymphoma-cnsl-100599313","NCT07082868","A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)","A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory\u002FRecurrent CNS Lymphoma (EIFEL-Trial)","Inclusion Criteria:\n\n* \\>\u002F= 18 years of age on the day of consenting to the study.\n* Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)\n* Participants must have an ECOG performance status of 0, 1, or 2.\n* Participants must have adequate bone marrow and organ function shown by:\n\n  * Absolute neutrophil count (ANC) ≥ 1 x 109\u002FL\n  * Platelets ≥ 75 x 109\u002FL and no platelet transfusion within the past 21 days prior to study consent\n  * Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 21 days prior to study consent\n  * International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal (unless receiving anticoagulation)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal\n  * Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.\n  * Creatinine clearance (CLCr) ≥ 30 ml\u002Fmin (based on the following formular Creatinine clearance= ((140-age)\\*wt)\u002F(creatinine\\*72); multiply by 0.85 for women)\n* Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose\n* Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry. See section on Pregnancy and Reproduction.\n\n  * Patients must be able to tolerate MRI\u002FCT scans.\n  * Due to the nature of this disease, we will allow patients with impaired decision-making ability to enroll into all cohorts.\n\nExclusion Criteria:\n\n* Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.\n* Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded\n* Patient is concurrently using other approved or investigational antineoplastic agents.\n* Patient has an active concurrent malignancy requiring active therapy\n* Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.\n* Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.\n* Patient requires more than 8 mg of dexamethasone daily or the equivalent\n* Patient is using warfarin or any other warfarin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed. Patients with congenital bleeding diathesis are excluded.\n* Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit for at least 3 days prior to Cycle 1 Day 1\n* Patient is taking a drug known to be a moderate or strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450\u002FCYP3A inhibitors and inducers for at least 5 half-lives or at least two weeks, whichever is shorter, prior to starting the study drug.\n* Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of \\> 5 mg\u002Fday of prednisone or the equivalent (for more than 12 months). Participants must be off of immunosuppressant therapy for at least 28 days prior to the first dose of the study drug.\n* Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening\n* Patient has an ejection fraction of \\\u003C50%\n* Patient has a known bleeding diathesis (e.g. von Willebrand's disease) or hemophilia.\n* Patient is documented to have human immunodeficiency virus (HIV) infection.\n* Patient is documented to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests.\n* Patient is known to have an uncontrolled active systemic infection.\n* Patient is unable to swallow capsules or has a disease or condition significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.\n* Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.\n* Patient has not received vaccination with live vaccines within 28 days prior to first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the last dose of study treatment. Note: COVID-19 non-replicating adenoviral vaccines are permitted with a minimum period of 3 days between the vaccine and a dose of study drug. It is highly recommended that every patient enrolled onto this trial has updated vaccination status (e.g. flu, hepatitis, polio, pertussis, tetanus; when is doubt please contact the PI or side-PI).\n* Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum hCG laboratory test of \\> 5 mIU\u002FmL\n\nPregnancy and Reproduction\n\nWomen:\n\n* Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \\>40 mIU\u002FmL and estradiol \\\u003C 20 pg\u002FmL or have had surgical bilateral oophorectomy with or without hysterectomy at least six weeks prior to enrollment in the study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up of hormone level assessment is she considered not of childbearing potential.\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 4 months after study discontinuation. Highly effective contraception is defined as either\n\n  * True abstinence: When this is the line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Sterilization: Surgical bilateral oophorectomy, with or without hysterectomy, or tubal ligation at least six weeks prior to study enrollment.\n  * Male partner sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female patients participating in the study, the vasectomized male partner should be the sole partner for that patient.\n  * Use of a combination of any two of the following:\n* Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n* Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal form\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository\n* Women of child-bearing potential must have one negative serum pregnancy tests at screening\n* In addition to having a negative pregnancy test confirmed at screening, all female participants of child bearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug.\n\nMen:\n\n* Fertile males, defined as all male subjects physiologically capable of conceiving offspring, must use a condom during study treatment and for 4 months after study discontinuation and should not father a child in this period.\n* Female partner of a male study subject should use a highly effective method of contraception while the male partner is receiving the study agent and for 4 months after the final dose of the study therapy.\n\nInclusion of women, minorities or other underrepresented populations\n\n* Ibrutinib and epcoritamab are not known to differentially affect subpopulations, including women, minorities, or other underrepresented groups. The eligibility and exclusion criteria are not expected to differentially impact recruitment or retention of these subpopulations.\n\nCovid-19 eligibility criteria\n\nSubject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs\u002Fsymptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection.\n\nSubjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:\n\n* No signs\u002Fsymptoms suggestive of active SARS-CoV-2 infection\n* Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart\n\nGiven the ongoing COVID-19 pandemic, selected non-live vaccines (e.g. mRNA, non-replicating viral vector, protein subunit, etc.) to prevent SARS-CoV-2 infections may be administered during screening or the treatment period, as long as components of the vaccine are not contraindicated. COVID-19 vaccines are permitted and strongly recommended.\n\nThe decision to receive a locally available vaccine should be based on local guidance and an individual discussion between the treating physician and the subject.\n\nThe potential impact of epcoritamab on SARS-CoV-2 vaccination is unknown. Therefore, study drug should be administered as follows:\n\n* The first dose of study drug, when possible, is preferred to be given at least 14 days from SARS-CoV-2 vaccine administration.\n* A minimum period of 3 days must occur between the administration of an appropriate COVID-19 vaccine and the administration od epcoritamab (to avoid overlapping AEs).\n\nNote: The above guidance applies to all SARS-CoV-2 vaccine doses given as part of the complete vaccination course.\n\nThese recommendations may be subject to change based on the evolving knowledge around the use of SARS-Cov-2 vaccines in subjects with recurrent\u002Frefractory DLBCL or cFL and as more data are collected in real-world scenarios and clinical trials.",{"count":67,"type":20},26,[23],"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).",[33,71,72,73,74,75,34],"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",[71,77,78,79,74,75,80,81,82,83,84],"PCNSL","Relapsed Primary Central Nervous Lymphoma","Refractory Primary Central Nervous Lymphoma","SCNSL","epcoritamab","ibrutinib","25-032","Memorial Sloan Kettering Cancer Center","2026-06-10",{"date":87,"type":50},"2026-06-11",{"date":89,"type":50},"2025-08-13",{"date":91,"type":20},"2028-08",{"name":84,"class":93},"OTHER",8,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100633211","phase-2-pomalidomide-anti-pd-1-antibody-combined-with-selinexor-pps-in-relapsedrefractory-primary-central-nervous-system-diffuse-large-b-cell-lymphoma-100633211","NCT07523737","Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed\u002FRefractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma","Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed\u002FRefractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL).\n* Disease progression or relapse after prior treatment with high-dose methotrexate and\u002For BTK inhibitors.\n* Age between 18 and 75 years.\n* ECOG performance status score 0-4.\n* Expected overall survival \\> 3 months.\n* No known hypersensitivity to any study drug.\n* White blood cell count ≥ 3×10⁹\u002FL; absolute neutrophil count ≥ 1.0×10⁹\u002FL; platelet count ≥ 50×10⁹\u002FL.\n* Serum creatinine ≤ 1.5 mg\u002FdL; creatinine clearance ≥ 50 mL\u002Fmin.\n* ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 2× ULN.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;\n* Female patients who are pregnant or breastfeeding;\n* Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures;\n* Known hypersensitivity to any study drug or any excipient ingredients of these products;\n* Active infection (determined by the investigator);\n* History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or history of organ transplantation;\n* Documented history of neurological or psychiatric disorders, including epilepsy or dementia;\n* Documented history of autoimmune diseases (except Hashimoto's thyroiditis or thyroid dysfunction);\n* Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.","75 Years",{"count":104,"type":20},43,[106],"PHASE2","Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed\u002Frefractory (R\u002FR) disease.\n\nTreatment options for R\u002FR PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R\u002FR PCNSL, aiming to provide a new effective treatment.",[33,28],[110,111,112,113,114,115],"diffuse large b cell lymphoma","primary central nervous system lymphoma","pomalidomide","PD-1 inhibitor","XPO1 inhibitor","selinexor","2026-04-10",{"date":118,"type":50},"2026-04-15",{"date":120,"type":50},"2026-04-01",{"date":122,"type":20},"2028-08-31",{"name":124,"class":93},"Beijing Tongren Hospital",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100426218","phase-1-a-study-of-nx-2127-in-adults-with-relapsedrefractory-b-cell-malignancies-100426218","NCT04830137","A Study of NX-2127 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Patients must have measurable disease per disease-specific response criteria\n* Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria)\n* Patients with transformed lymphoma are eligible for the study with the exception of those detailed in Exclusion Criteria #1: Prolymphocytic leukemia, MCL with blastoid histology, MCL with pleomorphic morphology, or MCL with known TP53 mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)\n* Adequate organ and bone marrow function\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol\n\nInclusion Criteria for Patients in Phase 1a:\n\n* Have histologically confirmed R\u002FR CLL, SLL, WM, MCL, and MZL, FL, DLBCL, or PCNSL\n* Received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and have no other therapies known to provide clinical benefit\n* Must require systemic therapy\n\nInclusion Criteria for Patients in Phase 1b:\n\n* Must have one of the following histologically documented R\u002FR B-cell malignancies:\n\n  * CLL\u002FSLL whose disease has failed treatment with a BTKi;\n  * MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen\n  * FL or MZL whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTKi\n  * PCNSL whose disease failed at least 1 prior line of treatment\n  * DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen, or another\u002F palliative regimen (either progressed post stem cell transplant or transplant-ineligible)\n\nExclusion Criteria:\n\n* Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia\n* History of known\u002Fsuspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.)\n* Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug\n* Bleeding diathesis, or other known risk for acute blood loss\n* Patients requiring ongoing treatment with warfarin or an equivalent vitamin K antagonist and within 7 days prior to the first dose of study drug\n* Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)\n* Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, hypothyroidism with adequate replacement therapy, hypopituitarism with adequate replacement therapy, peripheral neuropathy or hematologic parameters meeting inclusion criteria).\n* Active known second malignancy. Exception: patients with non-metastatic, non-melanoma skin cancer are eligible\n* Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active liver disease from any cause\n* Active viral reactivation (e.g., CMV or EBV)\n* Use of systemic corticosteroids exceeding 20 mg\u002Fday prednisone (or equivalent) for non-PCNSL indications within 15 days prior to the planned start of study drug. PCNSL patients may not exceed corticosteroid doses of 40 mg\u002Fday prednisone (or equivalent) and should be on a stable or decreasing dose for 7 days prior to planned study start.\n* Use of non-steroidal immunosuppressive drugs within 30 days prior to start of the study\n* Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug\n* Administration of any strong cytochrome P450 3A (CYP3A) inducers or inhibitors for 14 days prior to the first dose of study drug, and any P-glycoprotein inhibitors (for 2 days) or moderate inducers of CYP3A for 7 days",{"count":134,"type":20},248,[23],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.",[26,27,32,30,31,29,138,33],"Diffuse Large B-cell Lymphoma (DLBCL)",[36,37,140,39,141,142,143,42,144,44,45,40,41],"B-cell Malignancy","IMiD","Lenalidomide","Pomalidomide","NX-2127","2026-03-18",{"date":147,"type":50},"2026-03-20",{"date":149,"type":50},"2021-05-05",{"date":151,"type":20},"2027-05",{"name":56,"class":57},16,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":125},"100624506","phase-2-pd-1-inhibitor-combined-with-rituximab-methotrexate-and-orelabrutinib-pd-1irmo-for-newly-diagnosed-pcnsl-and-scnsl-100624506","NCT07410520","PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) for Newly Diagnosed PCNSL and SCNSL.","A Multicenter, Open-Label, Single-Arm, Prospective Clinical Study of PD-1 Inhibitor Combined With Rituximab, Methotrexate, and Orelabrutinib (PD-1i+RMO) in the Treatment of Newly Diagnosed Primary Central Nervous System Lymphoma (ND-PCNSL) and Secondary Central Nervous System Lymphoma (SCNSL)","Inclusion Criteria:\n\n\\[1\\] Newly diagnosed PCNSL confirmed by histopathology, or independently relapsed SCNSL (diffuse large B-cell lymphoma), diagnosed according to the 2016 WHO diagnostic criteria.\n\n\\[2\\] Signed written informed consent, and ability to comply with protocol-specified visits and related procedures.\n\n\\[3\\] Cranial MRI (non-contrast + contrast) performed within 28 days prior to study enrollment must show at least one measurable lesion in two perpendicular dimensions (according to the 2014 Lugano criteria).\n\n\\[4\\] ECOG performance status of 0-4. \\[5\\] Adequate organ and bone marrow function, defined as follows:\n\n1. Hematology: Absolute neutrophil count (ANC) ≥ 1.0×10⁹\u002FL, platelet count (PLT) ≥ 50×10⁹\u002FL, hemoglobin (HGB) ≥ 8.0 g\u002FdL; no administration of granulocyte growth factors, platelet transfusion, or red blood cell transfusion within 7 days prior to testing.\n2. Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n3. Renal function: Serum creatinine (Cr) ≤ 1 × ULN or creatinine clearance (CCr) ≥ 90 mL\u002Fmin.\n4. Cardiac function: Cardiac function class below Grade III (NYHA criteria); echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ ULN + 10 s, and prothrombin time (PT) ≤ ULN + 3 s.\n6. Thyroid function: Baseline thyroid-stimulating hormone (TSH) level within normal range, or abnormal baseline TSH with normal T3\u002FT4 and no associated symptoms.\n\n\\[6\\] Life expectancy \\> 3 months. \\[7\\] Age ≥ 18 years. \\[8\\] Female subjects of childbearing potential or male subjects with female partners of childbearing potential must use effective contraception throughout the treatment period and for 90 days after the last dose.\n\nExclusion Criteria:\n\n1. Presence of disease involvement outside the central nervous system.\n2. History of a second primary malignancy (except for adequately treated non-melanoma skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, intramucosal carcinoma of the gastrointestinal tract, or breast carcinoma that has been cured and has shown no recurrence within the past 5 years).\n3. History of allergic disease, severe drug allergy, or known hypersensitivity to macromolecular protein preparations or any component of the PD-1 monoclonal antibody injection formulation.\n4. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or CAR-T cell therapy (or any other antibody targeting T-cell co-stimulation or checkpoint pathways).\n5. Previous allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n6. Planned to receive other systemic anti-tumor therapies during the study period.\n7. Use of anti-cancer vaccines or other immunostimulatory anti-tumor therapy within 3 months before the first dose.\n8. Severe acute or chronic infection requiring systemic therapy.\n9. Active, known, or suspected autoimmune disease (refer to Appendix 5), or history of such disease within the past 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in the past 2 years, hypothyroidism requiring only thyroid hormone replacement, or type 1 diabetes requiring only insulin replacement may be enrolled).\n10. Use of immunosuppressive drugs within 4 weeks prior to the first study treatment, excluding intranasal, inhaled, or other local glucocorticoids or physiologic doses of systemic glucocorticoids (i.e., no more than 10 mg\u002Fday prednisone or equivalent).\n11. Positive human immunodeficiency virus antibody (HIV-Ab), active hepatitis, or other uncontrolled infectious diseases.\n12. Current or previous history of idiopathic pulmonary fibrosis or idiopathic pneumonia.\n13. Known active tuberculosis.\n14. Previous history of grade ≥3 immune-related adverse events from prior immunotherapy.\n15. History of definite neurological or psychiatric disorders.\n16. Administration of any live vaccine against infectious diseases within 4 weeks before the first dose or planned use during the study period (e.g., influenza vaccine, chickenpox vaccine, etc.).\n17. Clear history of alcohol or drug abuse.\n18. Pregnancy or lactation.\n19. Participation in other investigational drug studies with active treatment within 1 month before the first dose.\n20. Any other condition that, in the investigator's judgment, may affect the evaluation of efficacy or safety in this study.",{"count":162,"type":20},50,[106],"This is a multicenter, open-label, single-arm, prospective clinical study of PD-1 inhibitor combined with rituximab, methotrexate, and orelabrutinib (PD-1i+RMO) in the treatment of newly diagnosed primary central nervous system lymphoma (ND-PCNSL) and secondary central nervous system lymphoma (SCNSL). The primary endpoint is 1-year progression-free survival (PFS).",[33,34],[167,168,169,170],"PD-1 Inhibitor","Rituximab","Methotrexate","Orelabrutinib","2026-02-08",{"date":173,"type":50},"2026-02-13",{"date":175,"type":20},"2026-02-07",{"date":177,"type":20},"2029-12-31",{"name":179,"class":93},"The First Affiliated Hospital with Nanjing Medical University",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":187,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":188,"targetDuration":190,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":125},"100607401","metabolic-and-immunomic-differential-analysis-of-primary-central-nervous-system-diffuse-large-b-cell-lymphoma-100607401","NCT07188077","Metabolic and Immunomic Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma","Differential Analysis of Primary Central Nervous System Diffuse Large B-Cell Lymphoma Based on Metabolomics and Immunomics","Inclusion Criteria:\n\n1. Aged between 18 and 75 years.\n2. The case group must have a confirmed diagnosis of primary central nervous system lymphoma (PCNSL) and must not have received any antitumor therapy prior to baseline sample collection.\n3. Must sign an informed consent form, agree to participate in this study, and provide samples and clinical information as required.\n4. Case group patients must have complete supporting imaging and pathology data.\n\nExclusion Criteria:\n\n1. Presence of other systemic malignancies.\n2. Presence of severe infections or metabolic disorders.\n3. Use of antimetabolites or chemotherapy drugs within one week prior to sample collection.\n4. Pregnant or lactating women.\n5. Concurrent severe internal medical conditions (e.g., end-stage renal disease, heart failure, liver failure).\n6. Patients unable to complete study requirements due to psychiatric disorders or cognitive impairment.",true,{"count":189,"type":20},20,"1 Year","OBSERVATIONAL","This study is a prospective cohort study. The case group will include patients with primary central nervous system lymphoma confirmed by imaging and pathology. The control group will include patients with pathologically confirmed diffuse large B-cell lymphoma who have been excluded from central nervous system involvement, as well as age- and gender-matched healthy volunteers (hematopoietic stem cell donors). Baseline data (as described below) will be collected. Patients with primary CNS lymphoma will undergo follow-up every 3 months, with immediate follow-up if clinical symptoms arise.",[33,194],"Diffuse Large B-Cell Lymphoma","2025-11-15",{"date":197,"type":50},"2025-11-18",{"date":199,"type":50},"2025-03-01",{"date":201,"type":20},"2027-03-01",{"name":203,"class":93},"Ting YANG",{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":21,"phases":214,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100608200","relmacabtagene-autoleucel-combined-with-autologous-hematopoietic-stem-cell-transplantation-orelabrutinib-and-sintilimab-for-primary-central-nervous-system-lymphoma-100608200","NCT07198464","Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma","A Prospective, Multicenter Clinical Study of Relmacabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation, Orelabrutinib, and Sintilimab for Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1.18-60 years 2.ECOG performance status 0-2 3.No prior treatment with CAR-T cell therapy or autologous stem cell transplantation (ASCT) 4.Expected survival ≥ 3 months 5.No history of malignancy (except for in situ carcinoma or other indolent malignancies), or inactive malignancy with treatment completed \\>1 year ago 6.Histopathologically confirmed PCNSL (lymphoma confined to the brain without systemic involvement, with histopathological type being diffuse large B-cell lymphoma, or systemic lymphoma with central nervous system involvement and histopathological type being diffuse large B-cell lymphoma) 7.Refractory disease is defined as failure to achieve complete remission after first-line therapy (excluding intolerance to first-line therapy), including: Progressive disease (PD) as best response to first-line therapy, or Stable disease (SD) as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP), or Residual disease after at least 6 cycles of first-line therapy, or relapse within 12 months after completing first-line therapy 8.Relapsed disease is defined as recurrence after achieving complete remission following first-line therapy, occurring within 12 months after treatment completion 9.Positive CD19 expression by immunohistochemistry 10.No contraindications for CAR-T cell therapy or ASCT 11.No concurrent use of other anti-tumor therapies during this treatment; bisphosphonates for bone metastases and symptomatic supportive treatments are allowed 12.Able to understand the study and provide signed Informed Consent Form\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Any uncontrolled medical condition (including active infection, uncontrolled diabetes, severe cardiac, hepatic or renal insufficiency, interstitial pneumonia, etc.)\n3. Use of systemic corticosteroids within 7 days before CD19 CAR-T cell infusion (except ≤ 5 mg\u002Fday dexamethasone or equivalent doses of other corticosteroids)\n4. Prior exposure to ≥ 2 of the following agents with documented resistance: orelabrutinib, fotemustine, carmustine, thiotepa, or PD-1\u002FPD-L1 inhibitors\n5. History of autoimmune disease\n6. Presence of cachexia or any other contraindication to chemotherapy\n7. Active, uncontrolled infection\n8. History of poorly controlled psychiatric disorder\n9. Any condition that, in the opinion of the investigator, would preclude safe participation in this trial","60 Years",{"count":213,"type":20},30,[215],"NA","To evaluate the efficacy and safety of relmacabtagene autoleucel combined with autologous hematopoietic stem cell transplantation, orelabrutinib, and sintilimab as first-line or relapsed\u002Frefractory treatment for primary central nervous system diffuse large B-cell lymphoma.",[33],"NOT_YET_RECRUITING","2025-09-22",{"date":221,"type":50},"2025-09-30",{"date":223,"type":20},"2025-10-07",{"date":225,"type":20},"2029-10-01",{"name":227,"class":93},"Zhengzhou University",{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":125},"100598667","combination-regimen-of-teniposide-pd-1-monoclonal-antibody-and-selinixor-for-patients-with-relapsed-or-refractory-pcnsl-100598667","NCT07074470","Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed or Refractory PCNSL","A Prospective Study of Combination Regimen of Teniposide, PD-1 Monoclonal Antibody and Selinixor for Patients With Relapsed and Refractory Primary Central Nervous System Lymphoma.","VPX","Inclusion Criteria:\n\n1. Age between 18 and 75 years old (inclusive).\n2. Participants must be able to understand and willing to sign a written informed consent form.\n3. The Eastern Cooperative Oncology Group is in a state of 0 to 3.\n4. The expected lifespan is ≥ 3 months (according to researchers).\n5. Primary central nervous system lymphoma of B-cell origin confirmed by pathology (histology or cytology).\n6. Measurable diseases are defined as having a short diameter of at least 1.0cm through enhanced MRI.\n7. Recurrent\u002Frefractory PCNSL: Must have received at least one systemic treatment based on high-dose methotrexate.\n8. Any non hematological toxicity related to previous treatment should be restored to grade 1 or normal (excluding hair loss according to NCI CTCAE 5.0).\n9. Bone marrow and organ function meet the following criteria (no blood transfusion, no G-CSF, no medication correction within 14 days prior to screening):\n\n   Bone marrow function: absolute value of neutrophils ≥ 1.5 × 10 \\^ 9\u002FL, platelets ≥ 80 × 10 \\^ 9\u002FL, hemoglobin ≥ 80 g\u002FL; Liver function: serum total bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN, if there is liver metastasis); Glutamate oxalate transaminase (AST) and glutamate pyruvate transaminase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN, if there is liver metastasis); Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance rate ≥ 60 mL\u002Fmin (male: Cr (ml\u002Fmin)=(140 years old) × body weight (kg)\u002F72 × serum creatinine concentration (mg\u002Fdl); Female: Cr (ml\u002Fmin)=(140 years old) x body weight (kg)\u002F85 x serum creatinine concentration (mg\u002Fdl)\n10. Women with reproductive potential must agree to use efficient contraceptive methods during treatment and within 6 months after the last study drug administration. Sexually active males must agree to use highly effective contraceptive measures during treatment and within 6 months after the last dose of medication.\n11. Can accept multiple MRI\u002FCT and lumbar puncture examinations.\n12. Swallowing oral tablets\u002Fcapsules is not difficult.\n13. Good compliance, willing to follow inspection procedures such as visit schedule, medication schedule, laboratory tests, etc.\n\nExclusion Criteria:\n\n1. Chemotherapy, radiotherapy, immunotherapy, or antibody therapy for anti-tumor treatment, or herbal medicine with anti-tumor indications, small molecule targeted therapy within 2 weeks, monoclonal antibody conjugate drug or cytotoxic therapy within 10 weeks.\n2. Participate in another clinical study using the research product within 4 weeks prior to the first day of treatment.\n3. Patients who have used systemic corticosteroids for more than 5 days within 14 days prior to medication or require daily administration of\\>10mg dexamethasone or equivalent medication to control central nervous system disorders.\n4. Active concurrent malignant tumors that require active treatment.\n5. Patients who have received previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, selenidazole, and tiniposide drugs within 6 months prior to initial administration.\n6. Suffering from uncontrolled or severe cardiovascular disease, including (but not limited to): any of the following: congestive heart failure (NYHA class III or IV); miocardial infarction; Unstable angina pectoris; Or there may be arrhythmia requiring treatment during screening, and the left ventricular ejection fraction (LVEF) within 6 months prior to initial administration is less than 50%; Primary cardiomyopathy (e.g. dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy); A clinically significant medical history of QTc prolongation, grade II type II atrioventricular block or grade III atrioventricular block, or QTc interval (Method F)\\>470 milliseconds (females) or\\>480 milliseconds (males); Atrial fibrillation (EHRA ≥ 2b); Uncontrollable hypertensive patients are considered unsuitable to participate in this study.\n7. Uncontrolled infections or infections requiring intravenous antibiotic treatment.\n8. Chronic hepatitis B carriers with active hepatitis B or C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA ≥ detection limit of each center; hepatitis C: HCV RNA positive) or syphilis. Attention: Non active carriers of HBV surface antigen (HBsAg), active HBV infection and persistent anti HBV suppression (HBV DNA\\\u003Cdetection limit per center) subjects, as well as HCV cured subjects, can be recruited.\n\n   Human immunodeficiency virus (HIV) infection\n9. Clinically significant gastrointestinal abnormalities that may affect drug intake, transportation, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy or gastric banding surgery.\n10. Previous allogeneic stem cell transplantation. Or those who have the intention of allogeneic hematopoietic stem cell transplantation;\n11. For female participants, they are currently pregnant or breastfeeding.\n12. Allergic to research drugs or excipients.\n13. The patient has active mental illness, alcohol, drug or substance abuse.\n14. There are any life-threatening diseases, medical conditions, or organ system dysfunction that researchers believe may affect patient safety or compliance with research procedures.\n15. There are other researchers who believe that it is not suitable to participate in this clinical trial.",{"count":237,"type":20},40,[215],"This study aims to evaluate the efficacy and safety of the VPX regimen, a novel combination of teniposide, PD-1 monoclonal antibody and selinexor, in patients with relapsed\u002Frefractory (R\u002FR) primary central nervous system lymphoma (PCNSL) who have progressed after high-dose methotrexate (HD-MTX)-based systemic therapy. By investigating this therapeutic approach, we seek to establish a new treatment paradigm that may improve clinical outcomes of this high-risk population.",[33],[234,77,242,243,115],"teniposide","PD-1","2025-07-18",{"date":246,"type":50},"2025-07-20",{"date":248,"type":50},"2025-01-02",{"date":250,"type":20},"2032-01-02",{"name":252,"class":93},"The First Affiliated Hospital of Soochow University",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":16,"minAge":260,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":125},"100594092","phase-2-high-dose-gemcitabine-busulfan-and-thiotepa-followed-by-asct-in-primary-central-nervous-system-lymphoma-100594092","NCT07014943","High-Dose Gemcitabine, Busulfan, and Thiotepa Followed by ASCT in Primary Central Nervous System Lymphoma","A Study of High Dose Gemcitabine, Busulfan and Thiotepa With Autologous Stem Cell Transplantation for Primary or Relapse Central Nervous System Lymphomas","Inclusion Criteria:\n\n1. age between 18 and 70 years;\n2. CNS status of complete remission (CR) or partial response (PR) as assessed by magnetic resonance imaging (MRI), positron emission tomography-computed tomography (PET\u002FCT), or CSF analysis (if applicable);\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2;\n4. absence of systemic lymphoma in the neck, chest, abdomen, and pelvis as assessed by CT and bone marrow biopsy;\n5. negative HIV and hepatitis virus infections (particularly hepatitis B or C, with HBV DNA ≥ 10,000 copies\u002FmL);\n6. left ventricular ejection fraction (LVEF) ≥50% and no uncontrolled arrythmias or symptomatic cardiac disease;\n7. forced expiratory volume in one second (FEV1) ≥70%;\n8. serum creatinine clearance ≥ 50 ml\u002Fmin and\u002For serum creatinine ≤ 1.8 mg\u002FdL;\n9. serum bilirubin ≤ 2 times the upper limit of normal, serum glutamate oxaloacetate transaminase (SGOT) and\u002For serum glutamate pyruvate transaminase (SGPT) ≤ 3 times the upper limit of normal.\n\nExclusion Criteria:\n\n1. relapse after stem cell transplantation;\n2. other uncontrolled malignancies;\n3. immunodeficiency;\n4. active infection requiring parenteral antibiotics;\n5. pregnant or lactation;\n6. severe psychiatric or psychological conditions.","16 Years","70 Years",{"count":263,"type":20},34,[106],"The goal of this single-arm, prospective study is to learn if high dose gemcitabine, busulfan and thiotepa with autologous stem cell transplantation to treat primary or relapse central nervous system lymphomas. It will learn about the safety and efficacy of combination therapy. The main question it aims to answer is:\n\nEfficacy and safety of the combination of high dose gemcitabine, busulfan and thiotepa as a bridging therapy to ASCT in patients with CNSL.\n\nParticipants will:\n\nTake gemcitabine (2.5 g\u002Fm²) was administered intravenously (IV) on Days -9 and -3, Busulfan (3.2 mg\u002Fkg) was given IV over 3 hours on Days -9 to -7, and thiotepa (5 mg\u002Fkg) was administered IV on Days -5, -4, and -3. Peripheral stem cells were infused on Day 0.\n\nVisit the clinic for checkups and tests in accordance with the International Primary CNS Lymphoma Group (IPCG).\n\nResearchers will observe the patients receiving GemBuTT regimen as conditioning therapy in CNSL.",[33],"2025-06-03",{"date":269,"type":50},"2025-06-11",{"date":271,"type":50},"2022-01-01",{"date":273,"type":20},"2026-12-31",{"name":275,"class":93},"Sichuan University",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":211,"enrollmentInfo":283,"targetDuration":4,"studyType":21,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":125},"100588823","rituximab-methotrexate-and-tepadina-induction-followed-by-etoposide-and-cytarabine-consolidation-in-primary-central-nervous-system-lymphoma-100588823","NCT06946407","Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma","A Prospective, Single-Arm Clinical Study of Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation for Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n* Age ≤ 60 years, male or female\n* Histologically and immunohistochemically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) without prior treatment\n* No evidence of systemic lymphatic or hematopoietic involvement or other systemic disease, based on thorough physical examination and imaging\u002Flaboratory tests\n* Diagnosis meets criteria for Primary Central Nervous System Lymphoma (PCNSL)\n* Written informed consent obtained from the patient or their legal guardian\n* Voluntary agreement to participate in the study\n\nExclusion Criteria:\n\n* Presence of another active malignancy\n* Known history of HIV infection or diagnosis of acquired immunodeficiency syndrome (AIDS)\n* Known allergy to any of the investigational drugs or their excipients\n* Any condition that, in the opinion of the investigator, may lead to early study termination, including but not limited to:\n* Severe comorbidities\n* Significant laboratory abnormalities\n* Serious social or family circumstances affecting safety or compliance",{"count":284,"type":20},41,[215],"High-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity.\n\nConsolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high.\n\nThis study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.",[33,288],"CNS Lymphoma Treatment",[77,290,291],"Induction Therapy","Consolidation Therapy","2025-04-23",{"date":294,"type":50},"2025-04-27",{"date":296,"type":50},"2022-12-02",{"date":298,"type":20},"2029-12-01",{"name":300,"class":93},"FengYan Jin",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":261,"enrollmentInfo":308,"targetDuration":4,"studyType":21,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":218,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":125},"100565748","phase-2-high-dose-methotrexate-combined-with-thiotepa-and-zanubrutinib-in-the-treatment-of-newly-diagnosed-pcnsl-mtz-100565748","NCT06646211","High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed PCNSL (MTZ)","A Single-arm, Multicenter Phase Ⅱclinical Study Evaluating High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed Central Nervous System Diffuse Large B-cell Lymphoma (MTZ)","Inclusion Criteria:\n\n1. Men and woman who are 18 to 70 years of age\n2. Histologically documented PCNSL\n3. ECOG performance status ≤ 2\n4. Life expectancy of \\> 3 months\n5. Imaging show at least one measurable lesion in the central nervous system.\n6. Adequate bone marrow and organ function shown by:\n7. Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n8. Platelets ≥ 75 x 10\\^9\u002FL and no platelet transfusion within the past 14 days\n9. Hemoglobin (Hgb) ≥ 8 g\u002FdL and no red blood cell (RBC) transfusion within the past 14 days\n10. International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal\n11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN\n12. Serum bilirubin ≤ 1.5×ULN\n13. Serum creatinine ≤ 2×ULN\n14. Lipase ≤ 1.5 x LUN\n15. Women of childbearing potential (WOCBP) and men must agree to use effective contraception when sexually active. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of medication; women who are pregnant or breastfeeding are not eligible to participate in this study. Women of childbearing potential: from the time of signing the Informed Consent Form (ICF) until 30 days after the study ends, sexually active men: from the time of signing the ICF until 90 days after the study ends, must use contraceptive measures.\n16. Must be able to tolerate MRI\u002FCT scans\n17. Must be able to tolerate lumbar puncture and\u002For Ommaya tap\n\nExclusion Criteria:\n\n1. Diagnosed with a malignant tumor other than PCNSL or has received treatment, except for the following cases:\n\n   1. Received curative treatment and has no known active disease at least 3 years or more before screening for enrollment.\n   2. Fully treated non-melanoma skin cancer or malignant lentigo, with no evidence of disease.\n   3. Fully treated carcinoma in situ, with no evidence of disease currently.\n2. 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\n3. Uncontrolled hypertension despite optimal medical management (per investigators assessment)\n4. Patient has poorly controlled diabetes (per investigators assessment)\n5. 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\n6. Cerebrovascular accident, deep vein thrombosis or pulmonary embolism within 3 months before the start of study treatment\n7. Non-healing wound, ulcer or bone fracture in a short time\n8. Known bleeding diathesis or hemophilia\n9. Known history of infection with human immunodeficiency virus (HIV) or active stage of infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) . Active HBV infection must be confirmed by a positive test for HBV surface antigen or a positive test for hepatitis B core antibody with a positive determination of HBV DNA by polymerase chain reaction (PCR). For Hepatitis C virus (HCV), confirmation must be made by a positive test for HCV antibodies, unless the subject has been treated and has shown a sustained virological response. Note: Subjects with positive HCV antibodies who have been treated and have shown a sustained virological response (negative virus detection for at least 6 months after completing treatment) will not be excluded.\n10. Patient underwent major systemic surgery ≤ 2 weeks prior to starting the trial treatment or who has not recovered from the side effects of such surgery\n11. Unable to swallow capsules or disease significantly affecting gastrointestinal function\n12. Life-threatening illness, medical conditions, or organ dysfunctions that may endanger the safety of the subject or put the study outcomes at risk.\n13. Lactating or pregnant\n14. Requires anticoagulation therapy with warfarin or equivalent vitamin K antagonists; requires treatment with potent CYP3A4\u002F5 inhibitors.\n15. Requires long-term use of dexamethasone ≥4mg\u002Fday or equivalent doses of corticosteroid formulations.\n16. Requires treatment with immunosuppressive agents, including cyclosporine A, tacrolimus, and sirolimus. Patients must discontinue the use of immunosuppressive agents 28 days before receiving study medication.",{"count":213,"type":20},[106],"This is a phase Ⅱ clinical study of Zanubrutinib(Z) in combination with methotrexate (M) and thiotepa(T) in treating newly diagnosed primary CNS lymphoma (PCNSL).\n\nThe purpose of the study is to test the efficacy and tolerability of a combination treatment of MTZ regimen in treating patients who have newly diagnosed PCNSL",[33,312],"Non Hodgkin Lymphoma (NHL)","2024-10-15",{"date":315,"type":50},"2024-10-17",{"date":317,"type":20},"2025-01-01",{"date":319,"type":20},"2028-01-01",{"name":321,"class":93},"Sun Yat-sen University"]