Many chemotherapy combinations may be used to treat patients with chronic lymphocytic leukemia (CLL). Although there are many options, a single, best option is not agreed upon by most cancer specialists. Bendamustine, a medicine recently approved for use in the United States, has been used in combination with rituximab in previous studies to treat patients whose CLL has returned after previous standard treatments. The purpose of this study is to determine whether bendamustine with rituximab is effective for the initial treatment of CLL for patients aged 65 and older.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Bendamustine 100 mg/m2 intravenously on days 1 and 2 on a 28-day cycle for 6 cycles
Rituximab 500 mg/m2 on a 28-day cycle for 6 cycles
University of Kentucky
Lexington, Kentucky, United States
Determine the response rate
Time frame: Defined by the 1996 NCI sponsored working group guidelines for the diagnosis and treatment of CLL
Describe the toxicity rates and severities
Time frame: Up to 2 years after enrollment
Describe the quality of life participants experience while receiving this combination therapy
Time frame: Up to 2 years after enrollment
Determine the health utility scores of participants while receiving this combination therapy
Time frame: Up to 2 years after enrollment
Conduct exploratory analyses of associations between clinical responses and protein expression and phosphorylation using novel flow cytometry methods
Time frame: Pre and Post treatment
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