Chronic Lymphocytic Leukemia (CLL) Clinical Trial
Official title:
NU 13H05: A Phase Ib Trial of Oncoquest-CLL Vaccine for Treatment-Naive Patients With Chronic Lymphocytic Leukemia
This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia. Liposome-based vaccines containing an extract of a person's cancer cells and the immunostimulant interleukin-2 may help the body to build an effective immune response to kill cancer cells.
PRIMARY OBJECTIVES: I. To evaluate the safety of vaccination with Oncoquest-Chronic Lymphocytic Leukemia (CLL) vaccine (autologous tumor cell extract vaccine). II. To evaluate the feasibility of Oncoquest-CLL production and administration to previously untreated patients with CLL. SECONDARY OBJECTIVES: I. To evaluate the clinical response [as defined by the International Workshop on Chronic Lymphocytic Leukemia 2008 (iwCLL2008)] of the Oncoquest-CLL vaccine in treatment-naive patients with CLL. II. To evaluate the T and B cell immune responses against autologous leukemia cells induced with Oncoquest-CLL vaccine. III. To measure the progression-free survival of patients treated with the Oncoquest-CLL vaccine. IV. To evaluate the change in absolute lymphocyte count and lymphocyte doubling time before and after vaccine administration and correlate this with immune response. OUTLINE: Patients receive autologous tumor vaccine subcutaneously (SC) on Study Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up monthly for 3 months, and then every 3 months for up to 1 year. ;
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