[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574680":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":26,"studyPopulation":11,"armGroups":27,"interventions":43,"overallOfficials":11,"centralContacts":60,"locations":66,"responsibleParty":84,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":11,"enrollmentInfo":100,"targetDuration":11,"studyType":103,"phases":104,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Vitebsk Regional Clinical Cancer Centre","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Adverse events incidence",null,"24 months",{"measure":14,"description":15,"timeFrame":12},"Safety","* To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability.\n* To explore the pharmacokinetics of CAR-T cells.",[17],{"measure":18,"description":11,"timeFrame":19},"Efficacy","- Overall response rate, including complete response (CR) and partial response (PR) rates. - Progression-free survival rates. - Overall survival rates. - MRD negativity rates measured by flow cytometry.",{"allocation":21,"interventionModel":22,"interventionModelDescription":11,"primaryPurpose":23,"observationalModel":11,"timePerspective":11,"maskingInfo":24},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":25,"maskingDescription":11,"whoMasked":11},"NONE","Patients receive ibrutinib 420 mg daily for 3 months before CAR T-cell infusion. Obinutuzumab 1000 mg is administered 14 days before leukapheresis to reduce circulating CLL cells. Lymphodepletion consists of fludarabine 25 mg\u002Fm² and cyclophosphamide 250 mg\u002Fm² on days -5 to -3. In a 3+3 dose-escalation design, patients receive a single infusion of 25 × 10⁶ (DL1), 50 × 10⁶ (DL2), or 100 × 10⁶ (DL3) autologous CD19 CAR T cells. Lenalidomide 10 mg is administered orally on days 0 through 6. 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\nThe main purposes of the Phase I part are:\n\n* To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability.\n* To explore the pharmacokinetics of CAR-T cells.\n\nThe main purposes of the Phase II part are:\n\n* Overall response rate, including complete response (CR) and partial response (PR) rates.\n* Progression-free survival rates.\n* Overall survival rates.\n* MRD negativity rates measured by flow cytometry.",[28,35,39],{"label":29,"type":30,"description":31,"interventionNames":32},"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.",[33,34],"Drug: Lenalidomide","Biological: Obinutuzumab Injection [Gazyva]",{"label":36,"type":30,"description":37,"interventionNames":38},"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.",[33,34],{"label":40,"type":30,"description":41,"interventionNames":42},"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.",[33,34],[44,51,55],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"DRUG","Lenalidomide","Lenalidomide 10mg per os 0- 6 days",[40,29,36],[50],"Revlimid",{"type":45,"name":46,"description":52,"armGroupLabels":53,"otherNames":54},"Lenalidomide 10 mg per os 1 -14 days",[40,29,36],[50],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":11},"BIOLOGICAL","Obinutuzumab Injection [Gazyva]","Combined with Lenalidomide 10 mg per os 1- 14 days for 6 cycles",[40,29,36],[61],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},"Mikalai Katsin","CONTACT","80297188691","oncogemvocod@gmail.com",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Hematology\u002FOncology department","RECRUITING","Vitebsk","Select A State","210023","Belarus","BY",{"type":76,"coordinates":77},"Point",[78,79],30.2049,55.1904,{"lat":79,"lon":78},[82],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":83},"katin@mail.com",{"type":85,"investigatorFullName":62,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Chief of Hematology\u002FOncology department",[88],{"name":89,"class":90},"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":101,"type":102},24,"ESTIMATED","INTERVENTIONAL",[105,106],"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.",[109,110],"Chronic Lymphocytic Leukaemia (CLL)","Small Lymphocytic Lymphoma (SLL)",[112,46,113],"anti-CD19 CAR T-cells","Ibrutinib","2026-08-12",{"date":116,"type":117},"2026-08-13","ACTUAL",{"date":119,"type":117},"2024-05-14",{"date":121,"type":102},"2026-08-31",{"name":5,"class":6},1]