Clinical trial · Interventional
Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia
A Phase 4 Study in the Treatment of Anemia With Weekly Epoetin Alfa Doses in Patients With Solid Tumors or Lymphoma Receiving Chemotherapy
NCT01374373CI-TRIAL-00021670completedPhase 4ClinicalTrials.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 assess safety and efficacy of weekly epoetin alfa (Hemax® ) administered for 12 weeks in patients with non curable solid tumors or lymphoma with anemia (hemoglobin \< 10g/dl) undergoing palliative care chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antineoplastic Chemotherapy Induced Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Open Label
- description
- One arm open label
- interventionNames
- Biological: Epoetin alfa
Primary outcomes (1)
- measure
- Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events
- timeFrame
- Baseline to 12 weeks
Secondary outcomes (3)
- measure
- Hemoglobin levels and percentage of responders
- timeFrame
- Every 4 weeks and 12 weeks
- description
- Evaluate efficacy assessing hemoglobin levels and percentage of responders (increments of Hemoglobin ≥ 1g/dl without transfusion requirements) comparing baseline with final 12 week and intermediate 4 week visits
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of non curable cancer or lymphoma * Receiving a palliative chemotherapy regimen * Hemoglobin \< 10.0 g/dL * Performance ≤ 3 of Eastern Cooperative Oncology Group (ECOG) performance status * Life expectancy of ≥ 3 months * Postmenopausal o premenopausal women receiving effective contraceptive method Exclusion Criteria: * Active bleeding that may have caused anemia in the prior 30 days. * Uncontrolled hypertension * Anemia for another cause other than cancer or chemotherapy * Untreated iron or folic acid deficiency * Transfusion in the last 30 days prior to baseline visit * Treatment with an erythropoiesis stimulating agent 3 months prior to the baseline visit * Increased risk of thromboembolic disease * Radiotherapy in pelvis or spine in the last 60 days * Myelodysplasic syndrome * History of congestive heart failure * Pregnant or lactating * Patient with known allergy to human albumin or related products
References
Publications (0)
Data not yet available
No reference posted for this study.