Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology
- Conditions
- Chemotherapy-induced Anemia
- Registration Number
- NCT02158169
- Lead Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Brief Summary
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.
- Detailed Description
This is a longitudinal, observational, prospective, multicentre, cohort study, conducted on a representative sample of public and/or private hospital-based oncologists and haematologists practicing in Metropolitan France.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2167
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia 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 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 Outcome Measures
Name Time Method Experience of patients treated with Retacrit® At 12 to 16 weeks from baseline or at the end of chemotherapy Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia Baseline visit Impact of iron supplementation on the doses of Retacrit® used, and on treatment duration At 12 to 16 weeks from baseline or at the end of chemotherapy Procedures for evaluating possible iron deficiency and iron supplementation At 12 to 16 weeks from baseline or at the end of chemotherapy
Trial Locations
- Locations (67)
Hopital Louis Pasteur
🇫🇷Colmar, Alsace, France
CH Emile Muller
🇫🇷Mulhouse, Alsace, France
CAC Paul Strauss
🇫🇷Strasbourg, Alsace, France
Chu Hopital Civil
🇫🇷Strasbourg, Alsace, France
Chu Rennes
🇫🇷Rennes, Basse Normandie, France
CHU SUD
🇫🇷Rennes, Basse Normandie, France
Clinique St Laurent
🇫🇷Rennes, Basse Normandie, France
Chp St Greg
🇫🇷St Gregoire, Basse Normandie, France
Ch St Malo
🇫🇷St Malo, Basse Normandie, France
CHG William MOREY
🇫🇷Chalon S/s, Bourgogne, France
Scroll for more (57 remaining)Hopital Louis Pasteur🇫🇷Colmar, Alsace, France