Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL) With Pentostatin, Alemtuzumab, and Low Dose Rituximab: A Phase II Clinical Trial

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL) meeting the following criteria:

- Minimum threshold peripheral blood lymphocyte count of 5 x 10^9/L (CLL variant)
OR adenopathy > 1 cm or palpable splenomegaly (SLL variant)

- Immunophenotypic demonstrations of a population of B lymphocytes (as defined by
CD19+) that are monoclonal (by light chain exclusion) AND have ≥ 3 of the
following characteristics:

- CD5+

- CD23+

- Dim surface light chain expression

- Dim surface CD20 expression

- FISH analysis is negative for IGH/CCND1 and/or immunostaining is negative
for cyclin D1 expression

- Must have progressive disease as indicated by any of the following characteristics
(based on standard criteria for treatment):

- Symptomatic CLL characterized by any of the following:

- Weight loss > 10% within the past 6 months

- Extreme fatigue

- Fevers > 38.5° C (not due to infection)

- Drenching night sweats without evidence of infection

- Evidence of progressive bone marrow failure with hemoglobin < 11 g/dL or
platelet count < 100 x 10^9/L

- Massive and progressive splenomegaly (> 6 cm below left costal margin)

- Massive (> 10 cm) or rapidly progressive lymphadenopathy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Creatinine ≤ 2 times upper limit of normal (ULN)

- Total bilirubin ≤ 3.0 times ULN OR direct bilirubin ≤ 1.5 times ULN

- AST ≤ 3.0 times ULN (unless due to hemolysis or CLL)

- Willing to provide mandatory blood samples for research studies

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for up to 12 months
after completion of study treatment

- No other active primary malignancy that requires treatment or limits survival to ≤ 2
years

- No active autoimmune hemolytic anemia, immune thrombocytopenia, or pure red blood
cell aplasia

- No New York Heart Association class III or IV heart disease

- No myocardial infarction within the past month

- No uncontrolled infection

- No HIV infection or AIDS

- No active hepatitis B infection (i.e., HBsAg or HBeAg positivity) or hepatitis C
infection by serology

- No other comorbid condition

PRIOR CONCURRENT THERAPY:

- No more than 3 prior treatment regimens for CLL that included purine analogue drugs
(e.g., fludarabine, pentostatin, or cladribine) OR previously untreated CLL in
patients with high-risk disease due to 17p13 deletion on FISH analysis

- More than 4 weeks since prior major surgery

- More than 2 months since prior alemtuzumab

- Prior corticosteroids allowed

- No concurrent continuous systemic corticosteroids