Clinical trial · Observational
Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology
Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation
NCT02158169CI-TRIAL-00018671SYNERGYcompletedClinicalTrials.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 aim of this study is to describe, in a real-life context, the impact of an epoetin alpha biosimilar, Retacrit®, on anaemia in patients receiving chemotherapy, according to concomitant iron supplementation.
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 |
|---|---|---|---|
| Chemotherapy-induced Anemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia
- timeFrame
- Patients are included at the time of the epoetin alpha biosimilar treatment initiation for chemotherapy-induced anemia and followed up to 12 to 16 weeks
- description
- The efficiency of epoetin alpha biosimilar will be assessed by the responders'rate according to European Society for Medical Oncology (ESMO) guidelines. This rate will be compared depending on the iron supplementation. The safety will be assessed by the record of adverse effects (serious or not) and treatment discontinuation.
Secondary outcomes (4)
- measure
- Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia
- timeFrame
- Baseline visit
- measure
- Procedures for evaluating possible iron deficiency and iron supplementation
- timeFrame
- At 12 to 16 weeks from baseline or at the end of chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, aged 18 years and older, seen by the oncologist or hematologist for chemotherapy. * Patients for whom the oncologist or hematologist has decided the initiation of an epoetin alpha biosimilar treatment (Retacrit®) for anemia. * Patients informed about the computer processing of their medical data and their right of access and correction. Exclusion Criteria: * Patients with hemoglobin concentrations \>11 g/dL. * Patients who have been transfused within the previous month. * Patients who are hypersensitive to erythropoietin or one of its excipients. * Patients participating or having participated in the previous month in a clinical trial in the field of anaemia in oncology. * Patients refusing to participate in the observational study.
References
Publications (0)
Data not yet available
No reference posted for this study.