[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kim, Seok Jin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100458133","phase-2-a-study-comparing-rituximabbendamustinrb-alternating-with-rituximabbendamustincytarabinrbac-with-rb-therapy-in-elderly-patients-with-mentle-cell-lymphoma-100458133",false,"NCT05245656","A Study Comparing Rituximab\u002FBendamustin(RB) Alternating With Rituximab\u002FBendamustin\u002FCytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma","A Randomized Phase II Trial Comparing Rituximab\u002FBendamustine(RB) Alternating With Rituximab\u002FBendamustine\u002FCytarabine(RBAC) With RB as Induction Therapy in Elderly Patients With Newly Diagnosed and Transplant-ineligible Mantle Cell Lymphoma","Inclusion Criteria:\n\n1. newly diagnosed, previously untreated, histologically confirmed CD20+ mantle cell lymphoma, confirmed by WHO classification criteria\n2. age ≥70 years or 60-69 years if the patients are ineligible for high-dose therapy with autologous stem cell transplantation.\n3. ECOG performance status 2 or less\n4. Adequate organ functions\n\n   * adequate heart function: LVEF ≥50% by echocardiography or MUGA\n   * adequate renal function: serum creatinine ≤ 2.0mg\u002FdL or CrCl ≥40 mL\u002Fmin based on the Cockcroft-Gault method\n   * adequate hepatic function: ≤2.5 times the upper limit of ALT (≤5 times the upper limit of ALT if the elevation is attributed by underlying lymphoma) and ≤2 times the upper limit of ALT (≤3 times the upper limit of total bilirubin if the elevation is attributed by underlying lymphoma)\n   * adequate hematologic function: absolute neutrophil counts (ANC) ≥ 1,500\u002FmL, platelet counts ≥ 100,000\u002FmL (any ANC and platelet counts are allowed, if they were related to bone marrow involvement)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. In-situ mantle cell lymphoma\n2. Ann Arbor stage 1 disease\n3. Prior treatment for Hodgkin lymphoma or non-Hodgkin lymphoma within the last 5 years.\n4. Active malignancy within the past 3 years except for localized non-melanoma skin cancer, papillary thyroid cancer, cervical carcinoma in situ, breast cancer in situ, or localized prostate cancer that has been definitely treated,\n5. Central nervous system involvement\n6. HBsAg (+) or anti-HBc Ab (+) (patients will be eligible if they receive appropriate prophylactic antiviral therapy using entecavir, tenofovir, and so on)\n7. History of prior hepatitis C infection (patients positive for HCV IgG will be eligible if they are negative for HCV-RNA)\n8. Known history of human immunodeficiency virus (HIV) infection\n9. any serious illness or medical conditions that are unstable or could jeopardize the safety of the patient and his\u002Fher compliance in the study\n\n   * Congestive heart failure ≥ NYHA class 3\n   * Acute coronary syndrome within 6 months (unstable angina or new-onset angina, myocardial infarct, or ventricular arrhythmia)\n   * History of significant neurological or psychological disorder including dementia and seizure disorder\n   * Severe chronic obstructive pulmonary disease with hypoxemia\n   * Cerebrovascular disease including transient ischemic attack within the past 6 months\n   * Non-healing wound, ulcer, or bone fracture\n   * Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n10. concomitant administration of any other experimental drugs under investigation\n11. Known hypersensitivity to bendamustine, rituximab, cytarabine, or mannitol\n12. major surgical procedure or significant trauma within 28 days before start of study treatment, open biopsy within 7 days before start of study treatment\n13. If the patient's partner is a woman who could possibly get pregnant, men who didn't have a vasectomy must agree to use medically recommended methods for adequate contraception (tubal ligation, intrauterine devices, or barriers \\[diaphragm, cervical cap\\] in the patient's partner and the use of condoms in men) when sexually active.","ALL","60 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase 2, multicenter, open-label, active-controlled randomized trial to determine efficacy and safety of rituximab\u002Fbendamustine (RB) alternating with rituximab\u002Fbendamustine\u002Fcytarabine (RBAC) compared with standard RB alone in the first-line treatment of elderly patients with mantle cell lymphoma, who are not eligible for high-dose therapy followed by autologous stem cell transplantation.",[26],"Mantle Cell Lymphoma","RECRUITING","2026-04-22",{"date":30,"type":31},"2026-04-23","ACTUAL",{"date":33,"type":31},"2022-10-18",{"date":35,"type":20},"2029-12-31",{"name":37,"class":38},"Kim, Seok Jin","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":39},"100410687","phase-2-study-of-lenalidomiderituximab-maintenance-for-transplantation-ineligible-patients-with-pcnsl-100410687","NCT04627753","Study of Lenalidomide\u002FRituximab Maintenance for Transplantation Ineligible Patients With PCNSL.","Phase II Study of Lenalidomide\u002FRituximab Maintenance for Transplantation Ineligible Patients With Primary CNS Diffuse Large B-cell Lymphoma (Nickname: Lemon-C Study)","Lemon-C","Inclusion Criteria:\n\n1. Those who have been diagnosed with histopathological primary central nervous system lymphoma and who have completed standard chemotherapy for induction of remission of primary central nervous system lymphoma have reached a complete or partial response.\n2. Those who are unable to transplant autologous hematopoietic stem cells for the following reasons\n\n   * If you are 65 years of age or older or if you are judged to have a weak systemic condition before receiving high-dose chemotherapy\n   * Refusal of autologous hematopoietic stem cell transplantation after high-dose chemotherapy\n3. Adequate laboratory functional values\n\n   * Absolute neutrophil count ≥ 1000\u002Ful\n   * Platelet count ≥ 50,000\u002Ful\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Serum calcium ≤ 12.0mg\u002FdL\n   * Serum creatinine ≤ 1.5 X UNL\n   * AST\u002FALT ≤ 2.5 X UNL\n   * Total bilirubin ≤ 1.5 X UNL\n4. Hepatitis B patients with combination of prophylactic antiviral therapy\n5. ECOG PS 0-2\n6. Those who can take oral medication\n7. Written informed consent under institutional guidelines.\n8. Female patients of child-bearing potential (FCBP) must have two negative pregnancy tests (sensitivity of at least 25 mIU\u002FmL) prior to starting lenalidomide. The first pregnancy test must be performed within 10 to 14 days prior to the start of lenalidomide, and the second pregnancy test must be performed within 24 hours prior to the start of lenalidomide.\n9. Effective method of contraception should be used during and for 28 days following the last dose of the drug\n\n   \\- FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n10. Male patients must use an effective barrier method of contraception during study and 28 days following the last dose if sexually active with a FCBP.\n\nExclusion Criteria:\n\n1. If autotransplantation is planned after chemotherapy\n2. Active congestive heart failure (New York Heart Association \\[NYHA\\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within six months prior to 1st day of 1st cycle.\n3. Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents.\n4. Uncontrolled hepatitis C infection and\u002For hepatitis B (except for patients with hepatitis B surface antigen \\[SAg\\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).\n5. . Known human immunodeficiency (HIV) seropositive\n6. Those who are unable to take oral medication\n7. Patients with a history of malignant tumors other than the target diseases except for the following cases\n\n   * If the tumor has not been treated for at least 5 years or is disease-free\n   * Patients at least 1 year after complete resection of basal cell carcinoma \u002F squamous cell carcinoma or successful treatment of cervical epithelial cancer\n8. Adverse reactions within 30 days prior to screening Severe gastrointestinal bleeding exceeding Grade 2 according to the Common Terms Criteria 4.03 version criteria\n9. Occurrence of blood clots or embolism within 6 months before starting screening\n10. Patients with hypersensitivity to THIS DRUG and other ingredients of THIS DRUG (e.g., angioedema, Stevens-Jones syndrome, toxic epidermal necrosis, etc.)\n11. Patients with seizure disorder requiring medication\n12. Female patients who are pregnant or lactating.\n13. Patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption.\n14. Patients with hyperreactivity to rituximab.","19 Years",{"count":50,"type":20},30,[23],"* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment.\n* The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration\n* Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone.\n* However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half.\n* Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).",[54],"Primary CNS Lymphoma",{"date":30,"type":31},{"date":57,"type":31},"2020-11-02",{"date":59,"type":20},"2028-11-02",{"name":37,"class":38},""]