Status:
COMPLETED
Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Leukemia, Lymphocytic, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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) le...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 1990
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1994
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00270049
Start Date
November 1 1990
End Date
January 1 1994
Last Update
May 18 2011
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