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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Pole 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 Dentellieres
    • 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 Chambéry
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospira, now a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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