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

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German CLL Study Group
• Treatments: Chlorambucil; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

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