Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01976520
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT01976520
Study Brief:
Protocol Section:
NCT01976520