Pilot Trial to Evaluate Immune Response Using Idiotype Vaccines Following High-Dose Chemotherapy and Hematopoietic Stem Cell Transplantation for Follicular Lymphoma
- Determine the humoral and cellular immune responses in patients with follicular
non-Hodgkin's lymphoma treated with autologous lymphoma-derived idiotype vaccine with
keyhole limpet hemocyanin plus sargramostim (GM-CSF).
- Determine the safety and toxicity of this regimen in these patients in the
- Determine the changes in quantitative bcl-2 in the blood and bone marrow of these
patients before and at various times after the series of idiotype vaccines.
OUTLINE: Vaccinations begin at day 100 or up to 6 months after hematopoietic stem cell
transplantation. Patients receive autologous lymphoma-derived idiotype vaccine plus keyhole
limpet hemocyanin subcutaneously (SC) on day 1. Sargramostim (GM-CSF) SC is administered on
days 1-4. Treatment repeats every 4 weeks for 4 doses, followed 12 weeks later by the fifth
and final dose.
Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Humoral and Cellular Immune Response
evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation
immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression
Julie M. Vose, MD
University of Nebraska
United States: Food and Drug Administration
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|