Anemia Clinical Trial
Official title:
Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex
vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic
leukemia.
SECONDARY OBJECTIVES:
I. To study immune reconstitution following infusion of activated T-cells in patients with
chronic lymphocytic leukemia.
II. To study the incidence of infections for up to 1 year following activated T cell
infusion.
III. To study the overall response rates.
OUTLINE:
Patients receive infusion of ex vivo-activated autologous lymph node lymphocytes
intravenously (IV) over 10-30 minutes on day 0.
Patients who have been previously treated on study, and subsequently need additional
infusions, may be retreated with previously cryopreserved expanded cells at the same or lower
dose level 6-12 months after the first infusion.
After completion of study treatment, patients are followed up at 1.5 years and then every 6
months for up to 5 years.
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