FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients

Inclusion Criteria

• Age ≥18 years
• Established diagnosis of B-cell CLL by NCI Working Group criteria
• ≤1 previous line of chemotherapy
• Expected survival >6 months
• Acceptable hematologic status, liver function, renal function, and pulmonary function
• Negative serum pregnancy test for both pre-menopausal women and for women who are 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen
• History of fludarabine-induced or clinically significant autoimmune cytopenia
• History of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low-grade early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent.
• Medical conditions requiring long term use (> 1 month) of systemic corticosteroids
• Active bacterial, viral, or fungal infection requiring systemic therapy
• Severe cardiac disease
• Seizure disorders requiring anticonvulsant therapy
• Severe chronic obstructive pulmonary disease with hypoxemia
• Uncontrolled diabetes mellitus or hypertension
• Transformation to aggressive B-cell malignancy.
• Known infection with HIV, HCV, or hepatitis B
• Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
• Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
• Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent