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Chemotherapy-induced AnemiaSYNERGYNCT02158169

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

An observational study of Chemotherapy-induced Anemia, run by Hospira, now a wholly owned subsidiary of Pfizer at 69 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chemotherapy-induced Anemia
How many people
2,167 participants
Where
69 sitesFrance
Study dates
Jun 2012to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

69 sites in 1 country.

69 sites in 1 country

France69 sites

  • Ch Du Pays D'Aix

    Aix-en-Provence, Marseille

  • Clinique Rambot

    Aix-en-Provence, Marseille

  • MEDIPOLE

    Aix-les-Bains, Auvergne-Rhône-Alpes

  • CHG

    Alès, Languedoc

  • Ico Angers

    Angers, Pays de la Loire Region

  • CHRA

    Annecy, Auvergne-Rhône-Alpes

  • Victor Dubos

    Argenteuil, Paris Nord

  • Clinique des Bonnettes

    Arras, Nord

  • Ch Duffaut

    Avignon, Marseille

  • CH Boulogne-sur-Mer

    Boulogne, Nord

  • Clinique CONVERT

    Bourg-en-Bresse, Auvergne-Rhône-Alpes

  • CHG Cahors

    Cahors, Midi Pyrennees

  • CHG

    Carcassonne, Languedoc

  • CHG William MOREY

    Chalon S/s, Bourgogne-Franche-Comté

  • Ch Chambery

    Chambéry, Auvergne-Rhône-Alpes

  • Chu Estaing

    Clermont, Massif Central

  • Chu Gabriel Montpied

    Clermont, Massif Central

  • Pole Sante Republique

    Clermont, Massif Central

  • BEAUJON

    Clichy, Paris Ouest

  • Hopital Louis Pasteur

    Colmar, Alsace

  • CHU du BOCAGE

    Dijon, Bourgogne-Franche-Comté

  • Clinique Pasteur

    Évreux, Haute Normandie

  • Chi Frejus - St Raphael

    Fréjus, Paca

  • Chu Grenoble

    Grenoble, Auvergne-Rhône-Alpes

  • Hopital Mignot

    Le Chesnay, Paris Ouest

  • Ch Le Mans

    Le Mans, Pays de la Loire Region

  • Victor Hugo

    Le Mans, Pays de la Loire Region

  • Hopital Franco Britannique

    Levallois-Perret, Paris Ouest

  • Centre Oscar Lambret

    Lille, Nord

  • Hopital Des Courses

    Maisons-Laffitte, Paris Ouest

  • Chu Timone

    Marseille, Marseille

  • Fondation Saint Joseph

    Marseille, Marseille

  • Hopital A.Pare

    Marseille, Marseille

  • IPC

    Marseille, Marseille

  • Clinique St Faron

    Meaux, Champagne

  • CH Jacques Monod

    Montivilliers, Haute Normandie

  • Clinique Vitalia Desertines

    Montluçon, Massif Central

  • Chu St Eloi

    Montpellier, Languedoc

  • CH Emile Muller

    Mulhouse, Alsace

  • HARTMANN

    Neuilly/seine, Paris Ouest

  • Clinique Belvédère

    Nice, Paca

  • CHU Caremeau

    Nîmes, Languedoc

  • Clinique Ste Marie

    Osny, Paris Nord

  • Saint Antoine

    Paris, Paris Nord

  • Saint Louis

    Paris, Paris Nord

  • TENON

    Paris, Paris Nord

  • Hpt Rene Dubos

    Pontoise, Paris Nord

  • Cac Jean Godinot

    Reims, Champagne

  • Chu Rennes

    Rennes, Basse Normandie

  • CHU SUD

    Rennes, Basse Normandie

  • Clinique St Laurent

    Rennes, Basse Normandie

  • CHR

    Roanne, Massif Central

  • Icl St Etienne

    Saint-Etienne, Massif Central

  • CHG St Gaudens

    Saint-Gaudens, Midi Pyrennees

  • Chp St Greg

    Saint-Grégoire, Basse Normandie

  • Hopital St Quentin

    Saint-Quentin, Champagne

  • Ch St Malo

    St-Malo, Basse Normandie

  • CAC Paul Strauss

    Strasbourg, Alsace

  • Chu Hopital Civil

    Strasbourg, Alsace

  • Hopital Foch

    Suresnes, Paris Ouest

  • Clinique de l'Ormeau

    Tarbes, Midi Pyrennees

  • CH Sainte Musse

    Toulon, Paca

  • H.I.A Saint Anne

    Toulon, Paca

  • CHU Purpan

    Toulouse, Midi Pyrennees

  • Clinique Pasteur

    Toulouse, Midi Pyrennees

  • Inst. Claudius Regaud

    Toulouse, Midi Pyrennees

  • Hopital Troyes

    Troyes, Champagne

  • Ch Valence

    Valence, Auvergne-Rhône-Alpes

  • Clinique des Dentellieres

    Valenciennes, Nord

Other trials in France

About this study

Official title: 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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 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 outcomes (4)

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

    Measured: Baseline visit

  2. Procedures for evaluating possible iron deficiency and iron supplementation

    Measured: 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

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

  4. Experience of patients treated with Retacrit®

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2014 (estimated)
  2. Study startJun 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158169
Sponsor's protocol ID
Synergy
Acronym
SYNERGY
Status last verified
Jul 2015
First submitted
4 Jun 2014
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chemotherapy-induced Anemia, run by Hospira, now a wholly owned subsidiary of Pfizer at 69 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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