| Inclusion Criteria: | 1) Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
2) Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time </= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
3) All patients must have a Zubrod performance status of </= 2.
4) All patients must be age >/= 18 years.
5) Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
6) All patients must have adequate renal function indicated by serum creatinine </=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST </= 2.5x ULN AND total bilirubin </= 2.5x ULN.
7) All patients must have a pre-treatment platelet count of >/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
8) All patients or appropriate surrogate must provide informed consent. |