This phase I trial tests the safety and effectiveness of pomalidomide after CD19 chimeric antigen receptor T-cell (CD19CART) therapy for the treatment of patients with CD19+ B-cell leukemias or lymphomas that have come back after a period of improvement (relapsed) or do not respond to treatment (refractory). Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells and are then re-infused into the patient. Following CAR T-cell infusion, CAR T-cells must expand and persist in the blood stream in order to most effectively treat leukemia/lymphoma. Pomalidomide stops the growth of blood vessels, stimulates the immune system, and may kill cancer cells. Research has shown that drugs like pomalidomide can modify the immune system and increase the number or improve the function of CAR T-cells in the blood. Pomalidomide may enhance the treatment effects of CAR T-cell therapy in patients who have received CD19CART therapy for relapsed or refractory CD19+ B-cell leukemia or lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07532525.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Active
Contact: Jennifer E. Agrusa
Phone: 734-647-3213
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of pomalidomide following CD19CART therapy for relapsed/refractory (R/R) CD19+ B-cell leukemia/lymphoma by measuring hematologic and non-hematologic toxicity within the first 56 days post-pomalidomide initiation.
SECONDARY OBJECTIVES:
I. To examine CD19CART transgene expression in recipients of pomalidomide post-CD19CART therapy by measuring CD19CART transgene expression at days 0, 7, 14, 28, and 56 following initiation of pomalidomide post-CD19CART therapy.
II. To estimate 1-year event-free survival (EFS), 1-year overall survival (OS), and duration of response (DOR) in recipients of pomalidomide following CD19CART.
III. To correlate transgene expression at days 0, 7, 14, 28, and 56 with 1- year OS.
IV. To assess T cell differentiation in the peripheral blood at days 0, 7, 14, 28, and 56 of study by evaluating immunophenotyping lymphocyte profiles.
V. To assess cytokine and chemokine concentrations in the peripheral blood by measuring serum cytokine and chemokine levels at days 0, 7, 14, 28, and 56 of study.
OUTLINE:
Patients receive pomalidomide orally (PO) once daily (QD) for 10 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples on study.
After completion of study treatment, patients are followed up at days 14, 21, 28 and 56, and then at 1 year.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorJennifer E. Agrusa