Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia

• Status: Completed
• Trial end date: 1994-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of treatment with epoetin alfa versus placebo on the percentage of red blood cells in anemic patients with chronic lymphocytic (white blood cell) leukemia and its effect on the patients' quality-of-life. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with chronic lymphocytic (white blood cell) leukemia

• having received either no cancer treatment, or treated with single-agent chemotherapy and/or prednisone for one month or a combination chemotherapy regimen

• having a Performance score of 0 (fully active, no disease restriction) to 3 (capable of only limited self-care, confined to bed or chair more than 50% of waking hours)

• having a life expectancy of at least 6 months

• having a hematocrit of <32%, a corrected reticulocyte count of <3%, platelets >25,000 cells/millimeter cubed, creatinine <2.0 mg/mL, a negative Coombs test (test for antibodies to red blood cells) and no occult blood in the stool

Exclusion Criteria:

• Patients with a clinically significant disease besides cancer

• having uncontrolled high blood pressure or a history of seizures

• received androgen therapy within 2 months of study

• received a transfusion within 1 week of study entry

• received radiation therapy within 1 month of study entry