[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574680":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":40,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":68,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":40,"enrollmentInfo":81,"targetDuration":40,"studyType":84,"phases":85,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":50,"whyStopped":40,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Vitebsk Regional Clinical Cancer Centre","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose antiCD19 CAR T-cells plus Lenalidomide","EXPERIMENTAL","Phase 1: Determine safety of IL-7\u002FIL-15 expanded 25x10\\^6 antiCD19 CAR-T cells with concomitant Lenalidomide 10 mg per os days 0-6 in patients with relapsed\u002Frefractory CLL. Patients will be enrolled in a 3+3 fashion. At day 28, patients with measurable residual disease (MRD)-positive disease are eligible for lenalidomide 10 mg 1-14 days per os plus obinutuzumab 1000 mg IV 1,8,15 days on cycle 1 and on day 1 on 2-6 cycles consolidation, whereas patients with MRD-negative disease receive lenalidomide 10 mg per os 1-14 days maintenance for 3 cycles.\n\n3 patients per cohort.",[13,14],"Drug: Lenalidomide","Biological: Obinutuzumab Injection [Gazyva]",{"label":16,"type":10,"description":17,"interventionNames":18},"Medium dose of antiCD19 CAR T-cell therapy plus Lenalidomide","Phase 1: Phase 1: Determine safety of IL-7\u002FIL-15 expanded 50x10\\^6 antiCD19 CAR-T cells with concomitant Lenalidomide 10 mg per os days 0-6 in patients with relapsed\u002Frefractory CLL. Patients will be enrolled in a 3+3 fashion. At day 28, patients with measurable residual disease (MRD)-positive disease are eligible for lenalidomide 10 mg 1-14 days per os plus obinutuzumab 1000 mg IV 1,8,15 days on cycle 1 and on day 1 on 2-6 cycles consolidation, whereas patients with MRD-negative disease receive lenalidomide 10 mg per os 1-14 days maintenance for 3 cycles. 3 patients per cohort.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"High dose antiCD19 CAR T-cell therapy plus Lenalidomide","Phase 1: Phase 1: Determine safety of IL-7\u002FIL-15 expanded 100x10\\^6 antiCD19 CAR-T cells with concomitant Lenalidomide 10 mg per os days 0-6 in patients with relapsed\u002Frefractory CLL. Patients will be enrolled in a 3+3 fashion. At day 28, patients with measurable residual disease (MRD)-positive disease are eligible for lenalidomide 10 mg 1-14 days per os plus obinutuzumab 1000 mg IV 1,8,15 days on cycle 1 and on day 1 on 2-6 cycles consolidation, whereas patients with MRD-negative disease receive lenalidomide 10 mg per os 1-14 days maintenance for 3 cycles. 9 patients per cohort.",[13,14],[24,31,35],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Lenalidomide","Lenalidomide 10mg per os 0- 6 days",[20,9,16],[30],"Revlimid",{"type":25,"name":26,"description":32,"armGroupLabels":33,"otherNames":34},"Lenalidomide 10 mg per os 1 -14 days",[20,9,16],[30],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BIOLOGICAL","Obinutuzumab Injection [Gazyva]","Combined with Lenalidomide 10 mg per os 1- 14 days for 6 cycles",[20,9,16],null,[42],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Mikalai Katsin","CONTACT","80297188691","oncogemvocod@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hematology\u002FOncology department","RECRUITING","Vitebsk","Select A State","210023","Belarus","BY",{"type":57,"coordinates":58},"Point",[59,60],30.2049,55.1904,{"lat":60,"lon":59},[63],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":64},"katin@mail.com",{"type":66,"investigatorFullName":43,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Chief of Hematology\u002FOncology department",[69],{"name":70,"class":71},"Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology","UNKNOWN","100574680","phase-iii-open-label-study-evaluating-the-safety-and-efficacy-of-concomitant-administration-of-anti-cd19-car-t-cell-therapy-and-lenalidomide-in-refractoryrelapsed-chronic-lymphocytic-leukemia-patients-100574680",false,"NCT06762431","Phase I\u002FII Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory\u002FRelapsed Chronic Lymphocytic Leukemia Patients.","VTB-CLL002","Inclusion Criteria:\n\n* Documented CD19+ CLL or SLL\n* Patients must have failed at least 1 prior regimen\n* Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:\n* Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity\n* ECOG Performance status 0 or 1\n* 18 years of age and older\n* Adequate organ system function including:\n\nCreatinine \\\u003C 1.6 mg\u002Fdl ALT\u002FAST \\\u003C 3x upper limit of normal Total Bilirubin \\\u003C2.0 mg\u002Fdl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.\n\n* Have no active GVHD and require no immunosuppression\n* Are more than 6 months from transplant\n* No contraindications for leukapheresis\n* Left Ventricular Ejection fraction \\>50%\n* Gives informed consent\n\nExclusion Criteria:\n\n* CLL patients with known or suspected transformed disease (i.e. Richter's transformation).\n* Pregnant or lactating women.\n* Uncontrolled active infection.\n* Active hepatitis B or hepatitis C infection.\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications.\n* Any uncontrolled active medical disorder\n* HIV infection.\n* Patients with active CNS involvement with malignancy.\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification.\n* Subjects with clinically apparent arrhythmia or arrhythmias who are not stable","ALL","18 Years",{"count":82,"type":83},24,"ESTIMATED","INTERVENTIONAL",[86,87],"PHASE1","PHASE2","This is a Phase I\u002FII interventional, open-label treatment study designed to evaluate the safety and efficacy of concomitant therapy with anti-CD19 CAR T-cells and Lenalidomide in adult patients with relapsed\u002Frefractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.",[90,91],"Chronic Lymphocytic Leukaemia (CLL)","Small Lymphocytic Lymphoma (SLL)",[93,26,94],"anti-CD19 CAR T-cells","Ibrutinib","2026-08-12",{"date":97,"type":98},"2026-08-13","ACTUAL",{"date":100,"type":98},"2024-05-14",{"date":102,"type":83},"2026-08-31",{"name":5,"class":6},1]