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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00270049
First received: December 22, 2005
Last updated: May 17, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Anemia
Leukemia, Lymphocytic, Chronic
Leukemia, Lymphocytic
Cancer
Neoplasms
Quality of Life
Drug: epoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

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)

Enrollment: 195
Study Start Date: November 1990
Study Completion Date: January 1994
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270049

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.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00270049     History of Changes
Other Study ID Numbers: CR005905
Study First Received: December 22, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
cancer
leukemia
chronic lymphocytic leukemia
lymphocytic leukemia
epoetin alfa
erythropoietin
red blood cells
transfusions
quality of life

Additional relevant MeSH terms:
Anemia
Neoplasms
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Hematologic Diseases
Neoplasms by Histologic Type
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014