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

PRIMARY OBJECTIVES:

I. To evaluate the safety of vaccination with Oncoquest-Chronic Lymphocytic Leukemia (CLL)
vaccine (autologous tumor cell extract vaccine).

II. To evaluate the feasibility of Oncoquest-CLL production and administration to previously
untreated patients with CLL.

SECONDARY OBJECTIVES:

I. To evaluate the clinical response [as defined by the International Workshop on Chronic
Lymphocytic Leukemia 2008 (iwCLL2008)] of the Oncoquest-CLL vaccine in treatment-naive
patients with CLL.

II. To evaluate the T and B cell immune responses against autologous leukemia cells induced
with Oncoquest-CLL vaccine.

III. To measure the progression-free survival of patients treated with the Oncoquest-CLL
vaccine.

IV. To evaluate the change in absolute lymphocyte count and lymphocyte doubling time before
and after vaccine administration and correlate this with immune response.

OUTLINE:

Patients receive autologous tumor vaccine subcutaneously (SC) on Study Day 1 and 15, and then
monthly for 3 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 3 months, and then
every 3 months for up to 1 year.

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.