Clinical trial · Observational
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
NCT02140736CI-TRIAL-00074418ORHEOcompletedClinicalTrials.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 main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Symptomatic Anemia | — | UNRESOLVED | — |
| Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Malignant Hemopathies | — | UNRESOLVED | — |
| Myelomas | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin biosimilar | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with chemo-induced symptomatic anemia
- interventionNames
- Drug: Epoetin biosimilar
Primary outcomes (1)
- measure
- Change and corrected Hemoglobin levels
- timeFrame
- 6 months
- description
- Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
Secondary outcomes (5)
- measure
- Observe evolution of the biological indicators
- timeFrame
- 6 months
- description
- Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients of more than 18 years of age * Patients presenting with anemia following chemotherapy * Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy \-- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle) * Patients eligible for epoetin alfa biosimilar treatment Exclusion Criteria: * Patients are not receiving chemotherapy * Patients already included in an epoetin zeta trial * Patients presenting with a contraindication to epoetin zeta * Patients presenting with hypersensitivity to the active principle or any of the excipients * Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA) * Patient with uncontrollable arterial hypertension * Patients who cannot receive adequate prophylaxis by antithrombotic agents
References
Publications (1)
- DERIVEDMichallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503. PMID 25011615