Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria

• •Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or IV) refractory B-cell chronic lymphocytic leukemia
• •Intermediate risk group must have evidence of active disease as shown by at least one of the following:
• •* Massive or progressive splenomegaly and/or lymphadenopathy
• •* Weight loss of greater than 10% in the last 6 months
• •* CALGB grade 2-4 fatigue
• •* Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection
• •* Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months
• •Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine
• •Lymphocytosis greater than 5000/mm3 at some time during disease
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •Creatinine no greater than 1.5 times ULN
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab)
• •At least 1, but no more than 3, prior chemotherapy regimens
• •At least 1 prior chemotherapy regimen comprising fludarabine
• •No other concurrent chemotherapy
• •No concurrent chronic use of oral corticosteroids
• •No concurrent hormone therapy except for non-disease related conditions
• •No concurrent dexamethasone or other corticosteroid-based antiemetics
• •No concurrent palliative radiotherapy