Tests CAR T-cell therapy with lenalidomide in relapsed chronic lymphocytic leukemia
Tests CAR T-cells given alongside lenalidomide in adults with returned chronic lymphocytic leukemia.
Plain-language title generated from the registry record
Registry title: Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.
Key facts
- Where
- Vitebsk, BelarusSee the site
- Phase
- Phase 1/2
Where in Belarus
- Hematology/Oncology departmentVitebsk, BelarusTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vitebsk Regional Clinical Cancer Centre
- Trial code
- NCT06762431
- Record updated
- 13 August 2026
- Original description
This is a Phase I/II 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/refractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.Read full original descriptionShow less
Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.
This is a Phase I/II 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/refractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.
Inclusion: Documented CD19+ CLL or SLL; Patients must have failed at least 1 prior regimen; Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:; Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity; ECOG Performance status 0 or 1; 18 years of age and older; Adequate organ system function including:; Creatinine < 1.6 mg/dl ALT/AST < 3x upper limit of normal Total Bilirubin <2.0 mg/dl 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; Have no active GVHD and require no immunosuppression; Are more than 6 months from transplant; No contraindications for leukapheresis; Left Ventricular Ejection fraction >50%; Gives informed consent.
Exclusion: Concurrent use of systemic steroids or chronic use of immunosuppressant medications; CLL patients with known or suspected transformed disease (i.e. Richter's transformation); Uncontrolled active infection; Active hepatitis B or hepatitis C infection; Any uncontrolled active medical disorder; HIV infection; Patients with active CNS involvement with malignancy; Class III/IV cardiovascular disability according to the New York Heart Association Classification; Subjects with clinically apparent arrhythmia or arrhythmias who are not stable; Pregnant or lactating women.