Phase II Trial of Rituxan(R) Plus FavId(TM) (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma

Inclusion Criteria

Inclusion Criteria

- 18 years of age or older

- Patients that are treatment naive OR

- Relapsed or refractory following chemotherapy OR

- Relapsed following a prior response to Rituxan(R) Note: Rituxan (R) may have been
given as second-line therapy following an initial response to chemotherapy or in
combination with chemotherapy for initial therapy of their disease.

- Tumor accessible for biopsy or previously existing recent biopsy material

- Measurable disease after node biopsy

- Histologically confirmed grade 1 or 2 follicular B-cell lymphoma (WHO classification)

- Performance status (ECOG) of 0, 1 or 2

- Absolute Granulocyte count > 1,000/mm3

- Platelets > 100,000/mm3

- Total Bilirubin <2 mg/dL

- AST and ALT <2x Upper Limit of Normal

- Creatinine < 1.5 mg/dL

Exclusion Criteria

- Patients who are refractory to Rituxan(R) Note: Patients who did not attain a CR or
PR are considered to be refractory

- More than 2 prior treatment regimens (e.g. CHOP plus Rituxan(R) is one treatment
regimen; CHOP followed by Rituxan(R) at initial relapse equals two treatment
regimens)

- Treatment w/Fludarabine within 9 months of study entry

- Patients with > 5,000 lymphocytes

- Prior tumor-specific idiotype immunotherapy using the identical idiotype (patients
whose idiotype has changed are eligible for retreatment with new idiotype)

- Concurrent immunosuppressive therapy (high-dose steroids; ect.)

- Known history of CNS lymphoma or meningeal lymphomatosis

- HIV positive

- Serious non-malignant disease (e.g., psychiatric disorders, compromised pulmonary
function (e.g. active asthma, COPD, pneumonitis, bronchiolitis obliterans),
congestive heart failure, or active uncontrolled bacterial, viral or fungal
infections), or other conditions which, in the opinion of the investigator would
compromise protocol objectives

- Prior malignancy (excluding non-melanoma carcinomas of the skin and in situ cervical
carcinomas) unless in remission for >2 years

- Treatment with an investigational drug within 8 weeks prior to study entry

- Pregnant or nursing women NOTE: Women of childbearing potential should be advised to
avoid becoming pregnant while receiving study treatment.