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Completed

NCT Number: NCT02158169

Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology

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.

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Key information

Conditions

Chemotherapy-induced Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Louis Pasteur, Colmar, Alsace, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia

    Time frame: 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 outcomes

  1. Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia

    Time frame: Baseline visit

  2. Procedures for evaluating possible iron deficiency and iron supplementation

    Time frame: At 12 to 16 weeks from baseline or at the end of chemotherapy

  3. Impact of iron supplementation on the doses of Retacrit® used, and on treatment duration

    Time frame: At 12 to 16 weeks from baseline or at the end of chemotherapy

  4. Experience of patients treated with Retacrit®

    Time frame: At 12 to 16 weeks from baseline or at the end of chemotherapy

Sponsors and collaborators

Lead sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation

Acronym: SYNERGY

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2014
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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