Trial Information

Pilot Study of Idiotype Vaccine and EPOCH-Rituximab Chemotherapy in Untreated Mantle Cell Lymphoma

Background:

- Mantle cell lymphoma presents a particular clinical challenge because it is aggressive
and incurable with chemotherapy. Thus, novel treatment approaches are needed.

- In follicular center cell lymphomas, another incurable disease, recent evidence
suggests that molecular complete remissions may be achieved following idiotype
vaccination in patients who have achieved minimal residual disease with combination
chemotherapy.

- These results suggest that idiotype vaccines may be able to induce a clinically
significant immune response against lymphoma.

Objectives:

- To assess if EPOCH-R/idiotype vaccination is associated with a median progression-free
survival consistent with 36 months;

- To assess if rituximab affects generation of T-cell immunity against the idiotype.

- To compare T-cell immunity using two different methods of isolating the idiotype
protein.

Eligibility:

- Tissue diagnosis of mantle cell lymphoma.

- Age greater than or equal to 18 years.

- Previously untreated with cytotoxic chemotherapy. All stages of disease.

- Lymph node of greater than or equal to 2 cm accessible for biopsy/harvest or greater
than 000/microl of circulating tumor cells in the blood. ECOG performance status less
than or equal to 3.

Design:

- In the present study, we propose to investigate the efficacy of idiotype vaccine
treatment in previously untreated patients with mantle cell lymphomas. In order to
achieve minimal residual disease, patients will receive 6 cycles EPOCH chemotherapy and
rituximab (EPOCH-R) followed by 5 idiotype vaccine injections.

- This study has completed accrual of 26 patients and is only open for follow-up.