Vaccine Therapy for Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria

• •1. Patients must have histologically confirmed B-CLL with low or intermediate risk disease as defined by the modified Rai criteria.
• •2. Patients must have lymphocytosis with white blood cells between 30,000-100,000/microliters (uL) in order to collect adequate leukemia cells for vaccine production.
• •3. Patients must have evidence of disease progression as demonstrated by an increase of more than 50% in lymphocytosis since diagnosis and/or lymphadenopathy and a lymphocyte doubling time of more than 6 months. Patients must have had at least 3 months of observation since diagnosis.
• •4. Patients must be age 18 years or older
• •5. Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •6. Patients must have adequate renal and hepatic function:
• •* Serum creatinine less than or equal to 2.0 mg/deciliter (dL)
• •* Total Bilirubin less than or equal to 2.0 mg/dL
• •* Serum glutamic-oxaloacetic transaminase/serum glutamate pyruvate transaminase (SGOT/SGPT) less than or equal to 2.5 x upper limit of normal (ULN)
• •7. Females of childbearing potential and sexually active males must consent to use of effective contraception. Child-bearing potential is defined as any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• •* Has not undergone a hysterectomy or bilateral oophorectomy; OR
• •* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding consecutive 12 months).
• •8. All patients must have given signed, informed consent prior to registration on study.