Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia
1 other identifier
interventional
195
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 1990
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1990
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1994
CompletedFirst Submitted
Initial submission to the registry
December 22, 2005
CompletedFirst Posted
Study publicly available on registry
December 26, 2005
CompletedMay 18, 2011
January 1, 2011
December 22, 2005
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 22, 2005
First Posted
December 26, 2005
Study Start
November 1, 1990
Study Completion
January 1, 1994
Last Updated
May 18, 2011
Record last verified: 2011-01