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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Given IV
Correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in \>50% of patients enrolled.
Time frame: Enrollment up to day 100 post T cell infusion for each arm.
Immune Reconstitution
To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia
Time frame: Up to 1 year
Overall Response Rates
The overall response rates between the lenalidomide and non-lenalidomide arms. For response to treatment, it was measured by International Workshop on CLL (iwCLL), criteria 2008 guidelines.
Time frame: Up to 1 year
Incidence of Infections
To study the incidence of infections for up to 1 year following activated T cell infusion
Time frame: Up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.