Trial Information

Randomized Trial of Patient-Specific Vaccination With Conjugated Follicular Lymphoma-Derived Idiotype (FNHLId1) With Local GM-CSF in First Complete Remission

Patients with Stage III-IV follicular lymphoma and tumor > 2cm (Stage II allowed if tumor >
5cm), previously untreated by other than local radiation, provide tumor material by tissue
biopsy for production of a patient-specific Ig idiotype vaccine conjugated to the
immunogenic protein KLH. After completing PACE or CHOP-R chemotherapy and achieving a
complete remission, followed by a waiting period to reconstitute the immune system, patients
who remain in remission randomized to the active treatment arm receive a series of 5
idiotype vaccinations accompanied by the immune stimulant GM-CSF. Patients randomized to the
control arm receive a time-matched series of KLH injections also accompanied by GM-CSF.
Patients are subsequently studied to observe their immune responses both to the non-specific
immune stimulating agents and for the specific immune response to the vaccine. Patients are
followed for a minimum of 4 years post-randomization or until relapse.