Clinical trial · Interventional
Epoetin Alfa for the Treatment of Anemia Resulting From Chronic Lymphocytic Leukemia
The Effect of Subcutaneous r-HuEPO in Patients With Chronic Lymphocytic Leukemia
NCT00270049CI-TRIAL-00004868completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Leukemia, Lymphocytic | Lymphoid Leukemia | ALIAS | 0.90 |
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin alfa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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)
- measure
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.