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

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (Industry)

Overall Status

Completed

CT.gov ID

NCT00270049

Collaborator

(none)

195

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Leukemia, Lymphocytic, Chronic Leukemia, Lymphocytic Cancer Neoplasms Quality of Life	Drug: epoetin alfa	Phase 2

Detailed Description

Cancer patients often experience anemia due to the disease itself, chemotherapy, or both. Quality of life is also affected, in part because of the fatigue associated with anemia. Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level may improve the quality of life and help patients live longer. This is a 12-week, double-blind, placebo-controlled, multicenter study to determine the effect of treatment with epoetin alfa on the percentage of red blood cells in anemic patients with chronic white blood cell leukemia. At the start of the study, patients were either receiving no chemotherapy, single-agent chemotherapy, and/or were on prednisone (steroid) treatment. Patients will be randomly assigned 2:1 to receive either epoetin alfa or placebo. Patients receiving epoetin alfa will receive subcutaneous (under the skin) epoetin alfa injections 3 times per week and patients on placebo will receive an equal volume of matching placebo, injected subcutaneously 3 times per week. Based on patients' rate of increase in red blood cell percentage, the original dose of 150 units per kilogram 3 times per week may be raised gradually to 300 units per kilogram 3 times per week, to reach a target red blood cell percentage of 38% to 40%. Patients achieving the target red blood cell percentage will be eligible for a 12-week open-label extension of the study, which will focus on safety findings. Effectiveness will be determined by the proportion of patients who reach the target red blood cell percentage of 38% to 40% by the end of the study, the number of transfusions required, the proportion of patients achieving a red blood cell percentage of 38% to 40% at any time during the study, and changes in quality of life parameters. Safety evaluations, including the incidence of adverse events, laboratory tests, and vital signs, will be performed throughout the study. The hypothesis of the study is that epoetin alfa will be superior to placebo in increasing the percentage of red blood cells to the target level, reducing the number of transfusions required, and improving the quality of life. Epoetin alfa 150 units per kilogram 3 times weekly subcutaneously for 12 weeks. Individualized dose increases of 50 mg/week depend on red blood cell response, up to a maximum 300 units per kilogram 3 times per week to obtain the target level of 38% to 40% red blood cells.

Study Design

Study Type:

Interventional

Actual Enrollment :

195 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia

Study Start Date :

Nov 1, 1990

Actual Study Completion Date :

Jan 1, 1994

Outcome Measures

Primary Outcome Measures

Percentage of patients who reach the target of 38% to 40% red blood cells at the end of the study; Safety including the incidence of adverse events []

Secondary Outcome Measures

Transfusion requirements; Proportion of patients achieving red blood cell percentage of 38% to 40% any time during the study (unrelated to transfusions); Quality of life (physician's global assessment and patient's ability to perform daily activities) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.