Clinical trial NCT02158169: Biosimilar Retacrit® in the Treatment of Chemotherapy-induced Anaemia in Oncology and Haematology
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Anemia
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2014-06-06
Enrollment: 2167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of an epoetin alpha biosimilar with or without iron supplementation on chemotherapy-induced anemia
timeFrame: 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:
measure: Characteristics of patients receiving treatment with an epoetin alpha biosimilar, Retacrit®, for chemotherapy induced anaemia
timeFrame: Baseline visit
measure: Procedures for evaluating possible iron deficiency and iron supplementation
timeFrame: At 12 to 16 weeks from baseline or at the end of chemotherapy
measure: Impact of iron supplementation on the doses of Retacrit® used, and on treatment duration
timeFrame: At 12 to 16 weeks from baseline or at the end of chemotherapy
measure: Experience of patients treated with Retacrit®
timeFrame: At 12 to 16 weeks from baseline or at the end of chemotherapy
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hopital Louis Pasteur
state: Alsace
city: Mulhouse
country: France
facility: CH Emile Muller
state: Alsace
city: Strasbourg
country: France
facility: CAC Paul Strauss
state: Alsace
city: Strasbourg
country: France
facility: Chu Hopital Civil
state: Alsace
city: Rennes
country: France
facility: Chu Rennes
state: Basse Normandie
city: Rennes
country: France
facility: CHU SUD
state: Basse Normandie
city: Rennes
country: France
facility: Clinique St Laurent
state: Basse Normandie
city: St Gregoire
country: France
facility: Chp St Greg
state: Basse Normandie
city: St Malo
country: France
facility: Ch St Malo
state: Basse Normandie
city: Chalon S/s
country: France
facility: CHG William MOREY
state: Bourgogne
city: Dijon
country: France
facility: CHU du BOCAGE
state: Bourgogne
city: Meaux
country: France
facility: Clinique St Faron
state: Champagne
city: Reims
country: France
facility: Cac Jean Godinot
state: Champagne
city: St Quentin
country: France
facility: Hopital St Quentin
state: Champagne
city: Troyes
country: France
facility: Hopital Troyes
state: Champagne
city: Evreux
country: France
facility: Clinique Pasteur
state: Haute Normandie
city: Montivilliers
country: France
facility: CH Jacques Monod
state: Haute Normandie
city: Ales
country: France
facility: CHG
state: Languedoc
city: Carcassonne
country: France
facility: CHG
state: Languedoc
city: Montpellier
country: France
facility: Chu St Eloi
state: Languedoc
city: Nimes
country: France
facility: CHU Caremeau
state: Languedoc
city: Aix En Provence
country: France
facility: Ch Du Pays D'Aix
state: Marseille
city: Aix En Provence
country: France
facility: Clinique Rambot
state: Marseille
city: Avignon
country: France
facility: Ch Duffaut
state: Marseille
city: Clermont
country: France
facility: Chu Estaing
state: Massif Central
city: Clermont
country: France
facility: Chu Gabriel Montpied
state: Massif Central
city: Clermont
country: France
facility: Pole Sante Republique
state: Massif Central
city: Montlucon
country: France
facility: Clinique Vitalia Desertines
state: Massif Central
city: Roanne
country: France
facility: CHR
state: Massif Central
city: St Etienne
country: France
facility: Icl St Etienne
state: Massif Central
city: Cahors
country: France
facility: CHG Cahors
state: Midi Pyrennees
city: St Gaudens
country: France
facility: CHG St Gaudens
state: Midi Pyrennees
city: Tarbes
country: France
facility: Clinique de l'Ormeau
state: Midi Pyrennees
city: Toulouse
country: France
facility: CHU Purpan
state: Midi Pyrennees
city: Toulouse
country: France
facility: Clinique Pasteur
state: Midi Pyrennees
city: Toulouse
country: France
facility: Inst. Claudius Regaud
state: Midi Pyrennees
city: Arras
country: France
facility: Clinique des Bonnettes
state: Nord
city: Boulogne
country: France
facility: CH Boulogne-sur-Mer
state: Nord
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
city: Valenciennes
country: France
facility: Clinique des Dentellieres
state: Nord
city: Frejus
country: France
facility: Chi Frejus - St Raphael
state: Paca
city: Nice
country: France
facility: Clinique Belvédère
state: Paca
city: Toulon
country: France
facility: CH Sainte Musse
state: Paca
city: Toulon
country: France
facility: H.I.A Saint Anne
state: Paca
city: Argenteuil
country: France
facility: Victor Dubos
state: Paris Nord
city: Osny
country: France
facility: Clinique Ste Marie
state: Paris Nord
city: Paris
country: France
facility: Saint Antoine
state: Paris Nord
city: Paris
country: France
facility: Saint Louis
state: Paris Nord
city: Paris
country: France
facility: TENON
state: Paris Nord
city: Pontoise
country: France
facility: Hpt Rene Dubos
state: Paris Nord
city: Clichy
country: France
facility: BEAUJON
state: Paris Ouest
city: Le Chesnay
country: France
facility: Hopital Mignot
state: Paris Ouest
city: Levallois Perret
country: France
facility: Hopital Franco Britannique
state: Paris Ouest
city: Maisons Laffitte
country: France
facility: Hopital Des Courses
state: Paris Ouest
city: Neuilly/seine
country: France
facility: HARTMANN
state: Paris Ouest
city: Suresnes
country: France
facility: Hopital Foch
state: Paris Ouest
city: Angers
country: France
facility: Ico Angers
state: Pays de La Loire
city: Le Mans
country: France
facility: Ch Le Mans
state: Pays de La Loire
city: Le Mans
country: France
facility: Victor Hugo
state: Pays de La Loire
city: Aix Les Bains
country: France
facility: MEDIPOLE
state: Rhone Alpes
city: Annecy
country: France
facility: CHRA
state: Rhone Alpes
city: Bourg en bresse
country: France
facility: Clinique CONVERT
state: Rhone Alpes
city: Chambery
country: France
facility: Ch Chambery
state: Rhone Alpes
city: Grenoble
country: France
facility: Chu Grenoble
state: Rhone Alpes
city: Valence
country: France
facility: Ch Valence
state: Rhone Alpes
city: Marseille
country: France
facility: Chu Timone
city: Marseille
country: France
facility: Fondation Saint Joseph
city: Marseille
country: France
facility: Hopital A.Pare
city: Marseille
country: France
facility: IPC
Study officials:
affiliation: Hospira, now a wholly owned subsidiary of Pfizer
name: Hélène ALBRAND, MD
role: STUDY_DIRECTOR
References: