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

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring Cancer vaccine, Chronic lymphocytic leukemia, CLL, Autologous vaccine, B cell leukemia Read More

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.

Exclusion Criteria:

1. Patients who meet any of the NCI Working Group criteria to initiate treatment for CLL are NOT eligible for participation
2. Patients who have had or are currently receiving any treatment for CLL, including chemotherapy, corticosteroids, biologic therapy, or immunotherapy are NOT eligible for participation.
3. Patients who are actively receiving steroids or non-steroidal antiinflammatory drugs (NSAIDs) on a chronic basis and who are unwilling and/or unable to discontinue while on study therapy are NOT eligible for participation. NOTE: Patients must have discontinued steroids or NSAIDs for 1 week prior to registration to be considered eligible for participation.
4. Patients who are receiving cyclosporine, tacrolimus, or other chronic immunosuppressive agents are NOT eligible for participation.
5. Patients who exhibit any active or ongoing autoimmune processes including, but not limited to, autoimmune hemolytic anemia or immune thrombocytopenia purpura, are NOT eligible for participation.
6. Although rare, the only exception to this would be patients with Hashimoto's thyroiditis who ARE eligible for participation.
7. Patients who demonstrate the presence of antibodies to HIV or hepatitis C or presence of hepatitis B surface antigen or other active infectious process that could suppress the immune system and potentially interfere with the development of an immune response to the tumor antigen are NOT eligible for participation.

8. Patients who have a previous or concomitant malignancy are NOT eligible for participation EXCEPT for the following:

   • Patients with curatively treated squamous or basal cell carcinoma of the skin or effectively treated carcinoma in situ of the cervix ARE eligible for participation.
   • Patient who had a stage 1 solid tumor which has been adequately treated with curative intent, and has been in remission for more than 1 year.
   • Patients with a prior solid tumor who have been in remission more than 5 years ARE eligible for participation.
9. Patients who exhibit any significant concurrent, uncontrolled medical or psychiatric condition that in the opinion of the investigator would compromise the patient's ability to tolerate this treatment are NOT eligible for participation.
10. Patients who are pregnant or lactating are NOT eligible for participation.