Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270049
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2005-12-22
Brief Title:
Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor were on prednisone steroid treatment Patients will be randomly assigned 21 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 mgweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None