[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lenalidomide\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lenalidomide":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100603226","phase-1-application-of-pd-1-inhibitors-tenofovir-chidamide-and-lenalidomide-in-relapsedrefractory-ebv-associated-lymphoproliferative-disorders-100603226",false,"NCT07133763","Application of PD-1 Inhibitors, Tenofovir, Chidamide, and Lenalidomide in Relapsed\u002FRefractory EBV-associated Lymphoproliferative Disorders.","A Multicenter, Single-Arm, Prospective Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of Relapsed or Refractory EBV-Associated Lymphoproliferative Disorders.","Inclusion Criteria:\n\n1. Histologically confirmed EBV-associated lymphoproliferative disorders, including EBV-positive B-cell LPD and EBV-positive T\u002FNK-cell LPD, with EBV-encoded RNA (EBER)+ by in situ hybridization, or EBV nuclear antigen (EBNA)+, or latent membrane protein (LMP1\u002F2)+ in the lesion tissue.\n2. Age ≤75 years with an ECOG performance status ≤2.\n3. At least one bidimensionally measurable lesion for evaluation: for nodal lesions, longest diameter ≥1.5 cm and shortest diameter ≥1.0 cm; for extranodal lesions, longest diameter ≥1.0 cm; or ≥20% monoclonal EBV-infected lymphocytes detected by flow cytometry.\n4. Expected survival of more than 3 months.\n5. Ability to comply with follow-up. Patients must be aware of the nature of their disease and voluntarily agree to participate in the study and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine levels \\>2 times the upper limit of normal, unless deemed lymphoma-related.\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL, unless the hematologic abnormalities are considered due to bone marrow infiltration by lymphoma.\n3. Patients who have experienced grade ≥3 neurotoxicity within the past 2 weeks.\n4. Patients with chronic heart failure classified as NYHA Class III or IV, or with left ventricular ejection fraction \\\u003C50%, or with a history within the past 6 months of any of the following: acute coronary syndrome, acute heart failure (Class III or IV), or significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, or post-resuscitation sudden cardiac arrest).\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002Fml) or active hepatitis C infection.\n6. Patients diagnosed with malignancies other than lymphoma or currently undergoing treatment for other cancers, except:\n\n   ① Those who have received curative treatment and have been disease-free for ≥5 years prior to enrollment;\n\n   ② Patients with adequately treated, non-melanoma skin cancers such as basal cell carcinoma without evidence of disease;\n\n   ③ Patients with adequately treated carcinoma in situ of the cervix without evidence of disease.\n7. Patients with other hematologic diseases (e.g., hemophilia, myelofibrosis) considered unsuitable for the study by the investigator.\n8. Patients with severe active infections.\n9. Patients who underwent Grade 2 or higher surgery within 3 weeks before treatment initiation.\n10. Patients with a history of substance abuse, or medical, psychological, or social conditions that may interfere with study participation or evaluation, as judged by the investigator.\n11. Any other condition the investigator considers unsuitable for study enrollment.\n12. Known hypersensitivity to any component of the investigational drugs.","ALL","0 Years","75 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a prospective, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of PD-1 inhibitor combined with tenofovir, chidamide, and lenalidomide in the treatment of relapsed or refractory Epstein-Barr virus (EBV)-associated lymphoproliferative disorders (LPDs). The primary endpoint is the overall response rate (ORR) at 3 months, including complete response (CR) and partial response (PR). Secondary endpoints include overall survival (OS), progression-free survival (PFS), as well as safety and tolerability assessments. Eligible patients must have histologically confirmed EBV-positive B-cell or T\u002FNK-cell LPDs with measurable lesions. This combination regimen targets multiple mechanisms, including inhibition of EBV replication, activation of the immune system, and enhancement of antitumor effects, aiming to provide an innovative therapeutic strategy for this challenging disease.",[28,29,30,31,32],"EBV-Associated Lymphoproliferative Disorders","PD-1 Inhibitor","Tenofovir","Chidamide","Lenalidomide",[28,29,34,31,35],"tenofovir","lenalidomide","NOT_YET_RECRUITING","2025-08-14",{"date":39,"type":40},"2025-08-21","ACTUAL",{"date":42,"type":21},"2025-09-01",{"date":44,"type":21},"2027-09-01",{"name":46,"class":47},"The Affiliated Hospital of Xuzhou Medical University","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":4},"100603227","phase-1-application-of-pd-1-inhibitors-combined-with-tenofovir-chidamide-and-lenalidomide-in-the-treatment-of-ebv-associated-diseases-100603227","NCT07133776","Application of PD-1 Inhibitors Combined With Tenofovir, Chidamide and Lenalidomide in the Treatment of EBV-associated Diseases.","A Multicenter, Single-Arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of PD-1 Inhibitor Combined With Tenofovir, Chidamide, and Lenalidomide in the Treatment of EBV-Associated Diseases","Inclusion Criteria:\n\n1. Diagnosed with EBV infectious diseases, including infectious mononucleosis, chronic active EBV infection, or other EBV infectious diseases;\n2. EBV DNA ≥ 10⁴ copies\u002FmL in whole blood or plasma;\n3. Age ≤ 75 years with ECOG performance status ≤ 2;\n4. Estimated life expectancy over 3 months;\n5. Patients must be able to undergo follow-up. They should understand the nature of their disease and voluntarily agree to participate in this study for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Patients with impaired liver or kidney function, specifically defined as serum direct bilirubin, indirect bilirubin, and\u002For ALT, AST, or serum creatinine \\>2 times the upper limit of normal (ULN), unless such abnormalities are attributed to lymphoma;\n2. Patients with bone marrow failure, defined as absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL or platelets \\\u003C75×10⁹\u002FL;\n3. Patients who have experienced grade III or higher neurotoxicity within the past 2 weeks;\n4. Patients with chronic heart failure classified as NYHA class III or IV, or left ventricular ejection fraction (LVEF) \\\u003C50%, or those with a history of the following cardiac events within the past 6 months: acute coronary syndrome, acute heart failure (NYHA class III or IV), or significant ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, or resuscitated sudden cardiac arrest);\n5. Patients with AIDS, syphilis, or active hepatitis B (HBV DNA \\>1×10⁴ copies\u002FmL) or hepatitis C infection;\n6. Patients with coexisting hematologic disorders (e.g., hemophilia, myelofibrosis) deemed unsuitable for inclusion by the investigator;\n7. Patients with severe concurrent infections;\n8. Patients who have undergone grade II or higher surgery within 3 weeks prior to treatment;\n9. Patients with substance abuse, medical, psychological, or social conditions that may interfere with study participation or the evaluation of study outcomes;\n10. Patients deemed unsuitable for enrollment by the investigator;\n11. Patients with known hypersensitivity to components of the investigational drug.",{"count":56,"type":21},30,[24,25],"Currently, treatment options for Epstein-Barr virus (EBV) infection are limited, with unsatisfactory efficacy and no established standard therapy. Therefore, our center is conducting a prospective, multicenter, single-arm clinical trial to evaluate the efficacy and safety of PD-1 inhibitor in combination with tenofovir, chidamide, and lenalidomide in patients with EBV infectious diseases, aiming to provide a more effective and safer therapeutic option for EBV infectious diseases.",[60,29,30,31,32],"Epstein-Barr Virus (EBV) Infection",[62,29,34,31,35],"Epstein-Barr Virus (EBV) infection",{"date":39,"type":40},{"date":42,"type":21},{"date":44,"type":21},{"name":46,"class":47},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":18,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100433318","phase-2-efficacy-and-safety-of-lenalidomide-plus-chop-vs-chop-in-patients-with-untreated-peripheral-t-cell-lymphoma-100433318","NCT04922567","Efficacy and Safety of Lenalidomide Plus CHOP vs CHOP in Patients With Untreated Peripheral T-Cell Lymphoma","Multi-center Randomized Study to Compare Efficacy and Safety of Lenalidomide Plus CHOP (L-CHOP) Versus CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma","Inclusion Criteria:\n\n1. Patients with histologically proven untreated peripheral T-cell lymphoma (include PTCL not otherwise specified, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, enteropathy-associated T cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Nodal peripheral T-cell lymphoma with T-follicular helper phenotype and Follicular T-cell lymphoma).\n2. Males and females of 18 years of age to 80 years of age.\n3. Patients have not received anti-tumor therapy.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n5. Fit chemotherapy indications and basic requirements, including no obvious abnormal function of heart, liver, lung and kidney: creatine ≤2.0×ULN, total bilirubin ≤2.0mg\u002Fdl, transaminases≤3×ULN.\n6. Normal peripheral hemogram: absolute neutrophil count(ANC)≥1.5×10\\^9\u002FL, hemoglobin(Hb)≥90g\u002FL, platelet(PLT)≥100×10\\^12\u002FL.\n7. None of other serious disease conflict with the therapeutic regimen.\n8. None of other malignant tumor.\n9. Pregnancy test of women at reproductive age must be negative.\n10. Estimated survival time ≥ 3 months with good compliance.\n11. Voluntary participation, cooperate with the experimental observation, and sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients with the following PTCL subtypes are excluded; extranodal natural killer(NK)\u002FT-cell lymphoma, T-prolymphocytic leukemia, T large granular lymphocytic leukemia, chronic lymphoproliferative disorder of NK cells, aggressive NK-cell leukemia, adult T-cell leukemia\u002F lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma, cutaneous T cell lymphoma, breast implant-associated anaplastic large-cell lymphoma.\n2. Transformed lymphoma.\n3. Patients with other malignancies in the past or now; or secondary lymphoma triggered by chemotherapy or radiotherapy of other malignancies.\n4. Already initiated lymphoma therapy (except for the prephase treatment specified for this study).\n5. Patients with primary central nervous system lymphoma or lymphoma involving central nervous system.\n6. Patients who have central nervous system or meninges involvements.\n7. Candidate for hematopoietic stem cell transplantation.\n8. Known hypersensitivity to medications to be used.\n9. Hemogram abnormality: ANC\\\u003C1.5×10\\^9\u002FL; or hemoglobin\\\u003C90 g\u002FL; or PLT\\\u003C100×10\\^9\u002FL.\n10. Known hepatic and renal insufficiency (creatine\\>2.0×ULN, total bilirubin\\>2.0 mg\u002Fdl，transaminases\\>3.0×ULN).\n11. Patients with decompensated heart failure; or with dilated cardiomyopathy; or with coronary heart disease of non-corresponding ST-segment in ECG diagnosis; or with myocardial infarction within 6 months.\n12. Patients with serious uncontrolled acute infection need to be treated with antibody therapies, or antiviral therapies; or serious accompanying disorder or impaired organ function.\n13. Know HIV-positivity; or HbsAg positivity; or hepatitis C virus-Ab positivity.\n14. Pregnancy or lactation period.\n15. Patients who participated in other clinical trials within 3 months.\n16. The researchers considered that patients should not be in this trial.","18 Years",{"count":76,"type":21},289,[25],"This study aims to compare the efficacy and safety of lenalidomide plus CHOP (L-CHOP) versus CHOP alone in patients with previously untreated peripheral T-cell lymphoma (PTCL)",[80,32,81],"Peripheral T-Cell Lymphoma","CHOP","RECRUITING","2022-11-03",{"date":85,"type":40},"2022-11-07",{"date":87,"type":40},"2021-04-01",{"date":89,"type":21},"2026-12-31",{"name":91,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1]