Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology
SYNERGY
Pharmaco-epidemiological Study on the Effect of Retacrit® on Chemotherapy Induced Anaemia in Standard Oncology and Haematology Practice: Impact of Concomitant Iron Supplementation
1 other identifier
observational
2,167
1 country
69
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2012
Typical duration for all trials
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 4, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJuly 28, 2015
July 1, 2015
2.5 years
June 4, 2014
July 27, 2015
Conditions
Outcome Measures
Primary Outcomes (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.
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)
Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia
Baseline visit
Procedures for evaluating possible iron deficiency and iron supplementation
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
At 12 to 16 weeks from baseline or at the end of chemotherapy
Experience of patients treated with Retacrit®
At 12 to 16 weeks from baseline or at the end of chemotherapy
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Hopital Louis Pasteur
Colmar, Alsace, France
CH Emile Muller
Mulhouse, Alsace, France
CAC Paul Strauss
Strasbourg, Alsace, France
Chu Hopital Civil
Strasbourg, Alsace, France
MEDIPOLE
Aix-les-Bains, Auvergne-Rhône-Alpes, France
CHRA
Annecy, Auvergne-Rhône-Alpes, France
Clinique CONVERT
Bourg-en-Bresse, Auvergne-Rhône-Alpes, France
Ch Chambery
Chambéry, Auvergne-Rhône-Alpes, France
Chu Grenoble
Grenoble, Auvergne-Rhône-Alpes, France
Ch Valence
Valence, Auvergne-Rhône-Alpes, France
Chu Rennes
Rennes, Basse Normandie, France
CHU SUD
Rennes, Basse Normandie, France
Clinique St Laurent
Rennes, Basse Normandie, France
Chp St Greg
Saint-Grégoire, Basse Normandie, France
Ch St Malo
St-Malo, Basse Normandie, France
CHG William MOREY
Chalon S/s, Bourgogne-Franche-Comté, France
CHU du BOCAGE
Dijon, Bourgogne-Franche-Comté, France
Clinique St Faron
Meaux, Champagne, France
Cac Jean Godinot
Reims, Champagne, France
Hopital St Quentin
Saint-Quentin, Champagne, France
Hopital Troyes
Troyes, Champagne, France
Clinique Pasteur
Évreux, Haute Normandie, France
CH Jacques Monod
Montivilliers, Haute Normandie, France
CHG
Alès, Languedoc, France
CHG
Carcassonne, Languedoc, France
Chu St Eloi
Montpellier, Languedoc, France
CHU Caremeau
Nîmes, Languedoc, France
Ch Du Pays D'Aix
Aix-en-Provence, Marseille, France
Clinique Rambot
Aix-en-Provence, Marseille, France
Ch Duffaut
Avignon, Marseille, France
Chu Timone
Marseille, Marseille, France
Fondation Saint Joseph
Marseille, Marseille, France
Hopital A.Pare
Marseille, Marseille, France
IPC
Marseille, Marseille, France
Chu Estaing
Clermont, Massif Central, France
Chu Gabriel Montpied
Clermont, Massif Central, France
Pole Sante Republique
Clermont, Massif Central, France
Clinique Vitalia Desertines
Montluçon, Massif Central, France
CHR
Roanne, Massif Central, France
Icl St Etienne
Saint-Etienne, Massif Central, France
CHG Cahors
Cahors, Midi Pyrennees, France
CHG St Gaudens
Saint-Gaudens, Midi Pyrennees, France
Clinique de l'Ormeau
Tarbes, Midi Pyrennees, France
CHU Purpan
Toulouse, Midi Pyrennees, France
Clinique Pasteur
Toulouse, Midi Pyrennees, France
Inst. Claudius Regaud
Toulouse, Midi Pyrennees, France
Clinique des Bonnettes
Arras, Nord, France
CH Boulogne-sur-Mer
Boulogne, Nord, France
Centre Oscar Lambret
Lille, Nord, France
Clinique des Dentellieres
Valenciennes, Nord, France
Chi Frejus - St Raphael
Fréjus, Paca, France
Clinique Belvédère
Nice, Paca, France
CH Sainte Musse
Toulon, Paca, France
H.I.A Saint Anne
Toulon, Paca, France
Victor Dubos
Argenteuil, Paris Nord, France
Clinique Ste Marie
Osny, Paris Nord, France
Saint Antoine
Paris, Paris Nord, France
Saint Louis
Paris, Paris Nord, France
TENON
Paris, Paris Nord, France
Hpt Rene Dubos
Pontoise, Paris Nord, France
BEAUJON
Clichy, Paris Ouest, France
Hopital Mignot
Le Chesnay, Paris Ouest, France
Hopital Franco Britannique
Levallois-Perret, Paris Ouest, France
Hopital Des Courses
Maisons-Laffitte, Paris Ouest, France
HARTMANN
Neuilly/seine, Paris Ouest, France
Hopital Foch
Suresnes, Paris Ouest, France
Ico Angers
Angers, Pays de la Loire Region, France
Ch Le Mans
Le Mans, Pays de la Loire Region, France
Victor Hugo
Le Mans, Pays de la Loire Region, France
Study Officials
- STUDY DIRECTOR
Hélène ALBRAND, MD
Hospira, now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2014
First Posted
June 6, 2014
Study Start
June 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 28, 2015
Record last verified: 2015-07