Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

OBJECTIVES:

Primary

• Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
• Compare the duration of remission in patients treated with these regimens.

Secondary

• Compare the incidence of toxicity, especially infections, in patients treated with these regimens.
• Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.
• Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.

PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Confirmed diagnosis of chronic lymphocytic leukemia, meeting any of the following staging criteria:

• Binet stage A with B symptoms
• Binet stage B or C, meeting 1 of the following criteria:

• Rapid disease progression
• Enlarged lymph nodes and organs
• Severe B symptoms
• Previously untreated disease

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• No thrombocytopenia
• No autoimmune hemolytic anemia

Hepatic

• Not specified

Renal

• Not specified

Other

• No severe organ dysfunction
• No other prior or concurrent neoplasm

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy