A Phase I/II Study of Daily Oral Polyphenon E in Asymptomatic, Rai Stage 0-II Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Confirmed diagnosis of chronic lymphocytic leukemia (CLL)

- Stage 0, I, or II disease

- Previously untreated disease

- Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the
diagnosis of CLL

- Absolute lymphocyte count > 10,000/mm^3

- Lymphocytosis must consist of small to moderate size lymphocytes, with ≤ 55%
prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically

- Phenotypically characterized B-CLL defined by all of the following criteria:

- A population of leukemic cells that co-expresses the B-cell antigen CD23 as
well as CD5 in the absence of other T-cell markers (CD3, CD2, etc.)

- Dim surface immunoglobulin expression

- Exclusively κ or λ light chains

- Mantle cell lymphoma must be excluded by demonstrating the absence of the
t(11:14) by FISH testing

- Patients who require chemotherapy for treatment of CLL, based on any of the following
criteria, are excluded:

- CLL-related symptoms requiring treatment, including any of the following:

- Unintentional weight loss ≥ 10% body weight within the previous 6 months

- Extreme fatigue

- Fevers > 100.5°F for 2 weeks without evidence of infection

- Night sweats without evidence of infection

- Evidence of progressive marrow failure due to CLL involvement of bone marrow as
manifested by the development of worsening anemia (hemoglobin < 11 g/dl) and/or
thrombocytopenia (platelet count < 100,000/mm^3)

- Thrombocytopenia due to immune phenomena (ITP) is permitted as long as
platelet count is ≥ 100,000/mm^3and the patient is not on active
pharmacologic therapy

- Massive (i.e. > 6 cm below left costal margin) or progressive splenomegaly

- Massive nodes or clusters (i.e., > 10 cm in longest diameter) or progressive
adenopathy

- Progressive lymphocytosis with an increase of > 50% over 2 month period, or an
anticipated lymphocyte doubling time of < 6 months

PATIENT CHARACTERISTICS:

- Platelet count ≥ 100,000/µL

- ANC ≥ 1500/µL

- Hemoglobin ≥ 11 g/dL

- Total or direct bilirubin ≤ 1.5 x upper limit of normal (ULN)

- AST (SGOT) and ALT (SGPT) ≤ 2 x ULN

- Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 40 mL/min

- May have a history of autoimmune hemolytic anemia (AIHA) and positive Coombs test
provided there has not been active hemolysis requiring transfusion or steroid
treatment ≤ 10 weeks prior to registration

- ECOG performance status 0, 1, or 2

- Life expectancy of ≥ 6 months

- No uncontrolled infection

- No myocardial infarction within the past 6 weeks

- No New York Heart Association class III or IV congestive heart failure

- Not pregnant or nursing

- Negative pregnancy test

- Must employ adequate contraception (condoms, diaphragm, birth control pills,
injections, intrauterine device [IUD], or abstinence, etc.) prior to study entry and
for the duration of study participation

- No other severe medical or psychiatric illness

- No active hemolysis requiring transfusion or other pharmacologic therapy

PRIOR CONCURRENT THERAPY:

- At least 8 weeks since prior and no other concurrent over the counter green tea or
green tea extract

- No prior daily use of over the counter green tea products for medicinal purposes for
> 4 weeks (phase II only)

- No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary
therapy considered investigational (utilized for a non-FDA-approved indication and in
the context of a research investigation)

- No concurrent combination anti-retroviral therapy for HIV positive patients

- No concurrent oral steroid preparations