A Single-Center, Single-Arm, Phase 1 Pilot Study of Pomalidomide Following CD19-Directed Chimeric Antigen Receptor T-Cell Therapy in Relapsed/Refractory CD19+ B-Cell Leukemias and Lymphomas
Summary
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- DrugPomalidomide
Given PO
Outcome measures
Primary
Incidence of adverse events
Will assess the safety and tolerability of pomalidomide following CD19 chimeric antigen receptor T-cell (CD19CART) therapy for recurrent/refractory B-cell leukemia/lymphoma. Hematologic and non-hematologic toxicity within the first 56 days following the initiation of pomalidomide will be monitored. All observed toxicities, including dose-limiting toxicity will be summarized in terms of type (organ affected or laboratory determination), severity (by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), duration, and reversibility or outcome. Tables will be created to summarize toxicities.
Time frame: Within first 56 days following pomalidomide initiation
Secondary
CD19CART transgene expression
Time frame: At days 0, 7, 14, 28, and 56
CD19CART transgene expression
Time frame: At 1 year
Overall survival
Time frame: Up to 1 year
Event-free survival (EFS)
Time frame: Up to 1 year
Duration of response
Time frame: Up to 1 year
Lymphocyte profiles
Time frame: At baseline and days 7, 14, 28, and 56
Serum cytokine and chemokine levels
Time frame: At baseline and days 7, 14, 28, and 56
Eligibility criteria
Study locations (1)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109