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

July 27, 2015 updated by: Hospira, now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • CHU Timone
      • Marseille, France
        • IPC
      • Marseille, France
        • Fondation Saint Joseph
      • Marseille, France
        • Hopital A.Pare
    • Alsace
      • Colmar, Alsace, France
        • Hôpital Louis Pasteur
      • Mulhouse, Alsace, France
        • CH Emile Muller
      • Strasbourg, Alsace, France
        • CAC Paul Strauss
      • Strasbourg, Alsace, France
        • Chu Hopital Civil
    • Basse Normandie
      • Rennes, Basse Normandie, France
        • CHU Rennes
      • Rennes, Basse Normandie, France
        • CHU Sud
      • Rennes, Basse Normandie, France
        • Clinique St Laurent
      • St Gregoire, Basse Normandie, France
        • Chp St Greg
      • St Malo, Basse Normandie, France
        • CH St Malo
    • Bourgogne
      • Chalon S/s, Bourgogne, France
        • CHG William MOREY
      • Dijon, Bourgogne, France
        • Chu Du Bocage
    • Champagne
      • Meaux, Champagne, France
        • Clinique St Faron
      • Reims, Champagne, France
        • CAC Jean Godinot
      • St Quentin, Champagne, France
        • Hopital St Quentin
      • Troyes, Champagne, France
        • Hopital Troyes
    • Haute Normandie
      • Evreux, Haute Normandie, France
        • Clinique Pasteur
      • Montivilliers, Haute Normandie, France
        • Ch Jacques Monod
    • Languedoc
      • Ales, Languedoc, France
        • CHG
      • Carcassonne, Languedoc, France
        • CHG
      • Montpellier, Languedoc, France
        • CHU St Eloi
      • Nimes, Languedoc, France
        • CHU Caremeau
    • Marseille
      • Aix En Provence, Marseille, France
        • CH du Pays D'Aix
      • Aix En Provence, Marseille, France
        • Clinique Rambot
      • Avignon, Marseille, France
        • Ch Duffaut
    • Massif Central
      • Clermont, Massif Central, France
        • CHU Estaing
      • Clermont, Massif Central, France
        • CHU Gabriel MONTPIED
      • Clermont, Massif Central, France
        • Pôle Santé République
      • Montlucon, Massif Central, France
        • Clinique Vitalia Desertines
      • Roanne, Massif Central, France
        • CHR
      • St Etienne, Massif Central, France
        • Icl St Etienne
    • Midi Pyrennees
      • Cahors, Midi Pyrennees, France
        • CHG Cahors
      • St Gaudens, Midi Pyrennees, France
        • CHG St Gaudens
      • Tarbes, Midi Pyrennees, France
        • Clinique de l'Ormeau
      • Toulouse, Midi Pyrennees, France
        • CHU Purpan
      • Toulouse, Midi Pyrennees, France
        • Clinique Pasteur
      • Toulouse, Midi Pyrennees, France
        • Inst. Claudius Regaud
    • Nord
      • Arras, Nord, France
        • Clinique des Bonnettes
      • Boulogne, Nord, France
        • Ch Boulogne-Sur-Mer
      • Lille, Nord, France
        • Centre Oscar Lambret
      • Valenciennes, Nord, France
        • Clinique des dentellières
    • Paca
      • Frejus, Paca, France
        • Chi Frejus - St Raphael
      • Nice, Paca, France
        • Clinique Belvédère
      • Toulon, Paca, France
        • CH Sainte Musse
      • Toulon, Paca, France
        • H.I.A Saint Anne
    • Paris Nord
      • Argenteuil, Paris Nord, France
        • Victor Dubos
      • Osny, Paris Nord, France
        • Clinique Ste Marie
      • Paris, Paris Nord, France
        • Saint Antoine
      • Paris, Paris Nord, France
        • Saint Louis
      • Paris, Paris Nord, France
        • Tenon
      • Pontoise, Paris Nord, France
        • Hpt Rene Dubos
    • Paris Ouest
      • Clichy, Paris Ouest, France
        • BEAUJON
      • Le Chesnay, Paris Ouest, France
        • Hopital Mignot
      • Levallois Perret, Paris Ouest, France
        • Hopital Franco Britannique
      • Maisons Laffitte, Paris Ouest, France
        • Hopital Des Courses
      • Neuilly/seine, Paris Ouest, France
        • HARTMANN
      • Suresnes, Paris Ouest, France
        • Hôpital Foch
    • Pays de La Loire
      • Angers, Pays de La Loire, France
        • ICO Angers
      • Le Mans, Pays de La Loire, France
        • CH Le Mans
      • Le Mans, Pays de La Loire, France
        • Victor Hugo
    • Rhone Alpes
      • Aix Les Bains, Rhone Alpes, France
        • Medipole
      • Annecy, Rhone Alpes, France
        • CHRA
      • Bourg en bresse, Rhone Alpes, France
        • Clinique Convert
      • Chambery, Rhone Alpes, France
        • CH Chambery
      • Grenoble, Rhone Alpes, France
        • CHU Grenoble
      • Valence, Rhone Alpes, France
        • CH Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients for whom the oncologist decides to initiate epoetin alpha biosimilar treatment (curative or prophylactic) will be asked to participate from treatment initiation (baseline visit) up to 12-16 weeks after inclusion.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia
Time Frame: Baseline visit
Baseline visit
Procedures for evaluating possible iron deficiency and iron supplementation
Time Frame: At 12 to 16 weeks from baseline or at the end of chemotherapy
At 12 to 16 weeks from baseline or at the end of chemotherapy
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
At 12 to 16 weeks from baseline or at the end of chemotherapy
Experience of patients treated with Retacrit®
Time Frame: At 12 to 16 weeks from baseline or at the end of chemotherapy
At 12 to 16 weeks from baseline or at the end of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospira, now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Hélène ALBRAND, MD, Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 27, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Synergy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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