A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach
1. To determine if patients with Binet Stage A CLL generate an immune response to an
antigen delivered by a DNA vaccine.
2. To determine if patients with Binet Stage A CLL generate an immune response to a tumor
derived antigen delivered by a DNA vaccine.
3. To determine the optimal dose of DNA vaccine to obtain anti-idiotype immune responses.
4. To characterize any adverse effects of idiotypic vaccination with a DNA vaccine.
5. To determine if DNA idiotypic vaccination is capable of inducing remission in Binet´s
Stage A CLL.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Continuous reassessment up to 1 year
Michael J. Keating, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|