About this trial
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.
Eligibility criteria
Qualifiers
Documented CD19+ CLL or SLL
Patients must have failed at least 1 prior regimen
Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
ECOG Performance status 0 or 1
Disqualifiers
CLL patients with known or suspected transformed disease (i.e. Richter's transformation).
Pregnant or lactating women.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Trial design
Treatments tested in this trial
- Lenalidomide
- Lenalidomide
- Obinutuzumab Injection [Gazyva]
Treatment groups
Sponsors and collaborators
Vitebsk Regional Clinical Cancer Centre
Lead sponsor
Republican Scientific and Practical Center for children's Oncology, Hematology and Immunology
Collaborator