Clinical trial · Observational
Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology
Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study
NCT01626547CI-TRIAL-00026512completedClinicalTrials.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 observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.
Conditions
Conditions (4)
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 Anaemia | — | UNRESOLVED | — |
| Malignant Lymphomas | Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]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
- Observation of blood value development
- timeFrame
- 6 months
- description
- Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
- measure
- Evaluation of the profiles of treated patients
- timeFrame
- 6 months
- measure
- Evaluation of prescriber's therapy plan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients age ≥18 years . * Patients present with chemotherapy-induced symptomatic anaemia. * Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their 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 study. * Patients presenting with the contraindications to epoetin zeta. * Patients presenting with the hypersensitivity to the active substance or any of the excipients. * The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA). * Patients with uncontrolled hypertension. * Patients who cannot receive adequate prophylaxis by antithrombotic agents.
References
Publications (0)
Data not yet available
No reference posted for this study.