Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma
- Determine the safety and tolerability of rituximab and high-dose cyclophosphamide
followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's
tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients
with relapsed Hodgkin lymphoma.
- Determine the immunologic response to this vaccine in these patients.
- Determine the 3-year relapse-free and overall survival of patients treated with this
- Determine the patterns of cellular immune reconstitution in patients treated with this
OUTLINE: This is an open-label study.
Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks
4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell
rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and
continuing until blood counts recover. Patients also receive vaccine therapy comprising an
allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL
vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.
After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3
years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability
Yvette L. Kasamon, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
J0528 , CDR0000441037
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|