Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia.

PURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of chronic lymphocytic leukemia (CLL) meeting 1 of the following criteria:

• Previously untreated disease

• Progressive or relapsed CLL after treatment with nonpurine analog-containing regimens as chlorambucil or bendamustine hydrochloride

• Meets 1 of the following staging criteria:

• Binet stage A disease with B symptoms requiring treatment

• Binet stage B disease requiring treatment, meeting ≥ 1 of the following criteria:

• Rapid disease progression

• Enlarged lymph nodes and organs

• Severe B symptoms

• Binet stage C disease

• Must have comorbidities (i.e., CIRS score > 6)

• Must have restricted kidney function (i.e., creatinine clearance < 70mL/min)

• No transformation to aggressive non-Hodgkin's lymphoma (Richter's syndrome)

PATIENT CHARACTERISTICS:

• Life expectancy > 6 months

• Creatinine clearance > 30 mL/min

• No active second malignancy

• No active bacterial, viral, or fungal infection

• No conditions that would preclude substitution of iron

• No severe myocardial, coronary, or respiratory insufficiency

• No severe liver insufficiency

• No known hypersensitivity to darbepoetin alfa

• No cerebral dysfunction that would preclude participation in the required study procedures

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No concurrent participation in another clinical trial