Clinical trial NCT02140736: Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
Official title: Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chemotherapy-induced Symptomatic Anemia
Solid Tumors
Malignant Hemopathies
Lymphomas
Myelomas
Keywords: Chemotherapy-induced anemia
Epoetin biosimilar
Lead sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 2333
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 suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.

Brief summary: The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.

Detailed description: This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin to correct haemoglobin levels.

Eligibility criteria: Inclusion Criteria:

* Patients of more than 18 years of age
* Patients presenting with anemia following chemotherapy
* Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following chemotherapy

  -- The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
* Patients eligible for epoetin alfa biosimilar treatment

Exclusion Criteria:

* Patients are not receiving chemotherapy
* Patients already included in an epoetin zeta trial
* Patients presenting with a contraindication to epoetin zeta
* Patients presenting with hypersensitivity to the active principle or any of the excipients
* Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
* Patient with uncontrollable arterial hypertension
* Patients who cannot receive adequate prophylaxis by antithrombotic agents

Primary outcomes:
measure: Change and corrected Hemoglobin levels
timeFrame: 6 months
Secondary outcomes:
measure: Observe evolution of the biological indicators
timeFrame: 6 months
measure: Study the profiles of treated patients
timeFrame: 6 months
measure: Assess the reasons for the prescriber's treatment regimens
timeFrame: 6 months
measure: Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics
timeFrame: 6 months
measure: Observation of the safety profiles of the Product (Epoetin Alfa)
timeFrame: 6 months
Other outcomes:
Locations:
city: Agen
country: France
city: Aix En Provence Cedex
country: France
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Aix En Provence
country: France
city: Ajaccio Cedex
country: France
city: Albi
country: France
city: Amboise
country: France
city: Amilly
country: France
city: Annecy
country: France
city: Antibes
country: France
city: Armentieres
country: France
city: Arras Cedex
country: France
city: Arras
country: France
city: AULNAY SOUS BOIS Cedex
country: France
city: Avignon Cedex 2
country: France
city: Avignon
country: France
city: Bayonne
country: France
city: Beauvais
country: France
city: Besancon Cedex
country: France
city: Besancon
country: France
city: Bethune
country: France
city: Beuvry
country: France
city: Beziers
country: France
city: Blois
country: France
city: Bois-guillaume
country: France
city: Bordeaux Cedex
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne Sur Mer
country: France
city: Brest Cedex
country: France
city: Brest
country: France
city: Brest
country: France
city: Bron
country: France
city: Caen
country: France
city: Caen
country: France
city: Cannes
country: France
city: Cannes
country: France
city: Carcassonne Cedex 9
country: France
city: Carcassonne
country: France
city: Castelnau Le Lez
country: France
city: Challes Les Eaux
country: France
city: Chalon/saonne
country: France
city: Chambery Cedex
country: France
city: Chambery
country: France
city: Chambery
country: France
city: Cherbourg-octeville
country: France
city: Clermont Ferrand Cedex 1
country: France
city: Colmar Cedex
country: France
city: Colmar
country: France
city: Colmar
country: France
city: Compiegne
country: France
city: Creteil
country: France
city: Croix Cedex
country: France
city: Croix
country: France
city: Desertines
country: France
city: Dijon Cedex
country: France
city: Draguignan Cedex
country: France
city: Draguignan Cedex
country: France
city: Draguignan
country: France
city: Dunkerque
country: France
city: Evreux
country: France
city: Feurs
country: France
city: Foix Cedex
country: France
city: Frejus Cedex
country: France
city: Frejus
country: France
city: Frejus
country: France
city: Freyming Merlebach
country: France
city: Fryming Merle BACH
country: France
city: Gap Cedex
country: France
city: GAP
country: France
city: Grasse
country: France
city: Haguenau
country: France
city: Hyeres
country: France
city: Hyeres
country: France
city: La Roche Sur Yon Cedex 9
country: France
city: La Rochelle Cedex 1
country: France
city: La Seyne Sur Mer
country: France
city: La Tronche
country: France
city: Le Blanc Mesnil
country: France
city: Le Mans Cedex 9
country: France
city: Lille Cedex
country: France
city: Lille
country: France
city: Lille
country: France
city: Limoges Cedex
country: France
city: Lyon Cedex 07
country: France
city: Lyon Cedex 8
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Macon Cedex
country: France
city: Mareuil LES MAUX
country: France
city: Marseille Cedex 08
country: France
city: Marseille Cedex 20
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Meaux
country: France
city: Metz Cedex 01
country: France
city: Metz Cedex 3
country: France
city: Monaco
country: France
city: Mont de Marsan
country: France
city: Montargis Cedex
country: France
city: Montauban
country: France
city: Montbeliard
country: France
city: Montbeliard
country: France
city: Montfermeil
country: France
city: Montpellier Cedex 5
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Morlaix
country: France
city: Moulins
country: France
city: Mulhouse Cedex
country: France
city: Mulhouse Cedex
country: France
city: Mulhouse
country: France
city: Mulhouse
country: France
city: Nancy
country: France
city: Nantes Saint Herblain
country: France
city: Nantes
country: France
city: Narbonne
country: France
city: Nice Cedex 03
country: France
city: Nice Cedex 2
country: France
city: Nice
country: France
city: Nice
country: France
city: Nimes
country: France
city: Niort
country: France
city: Nogent/Marne
country: France
city: Nîmes Cedex
country: France
city: Orleans
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan Cedex
country: France
city: Pessac
country: France
city: Pierre Benite Cedex
country: France
city: Poitiers
country: France
city: Pontoise
country: France
city: Pringy Cedex
country: France
city: Pringy
country: France
city: Reims
country: France
city: Rennes Cedex 9
country: France
city: Rouen
country: France
city: Rouen
country: France
city: Rouen
country: France
city: Saint Cloud
country: France
city: Saint Gaudens
country: France
city: Saint Germain En Laye
country: France
city: Saint Quentin
country: France
city: Sainte Feyre
country: France
city: Selestat
country: France
city: St Cloud
country: France
city: St Germain En Laye
country: France
city: St Germain
country: France
city: St HERBLAIN CEDEX
country: France
city: St Priest En Jarez Cedex
country: France
city: Strasbourg Cedex 2
country: France
city: Strasbourg Cedex
country: France
city: Strasbourg Cedex
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Strasbourg
country: France
city: Talence Cedex
country: France
city: Talence
country: France
city: Tarbes
country: France
city: Thionville
country: France
city: Thonon-les-bains
country: France
city: Toulon Cedex 9
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse Cedex 9
country: France
city: Toulouse
country: France
city: Tours Cedex 9
country: France
city: Tremblay En France
country: France
city: Troyes
country: France
city: Valence Cedex
country: France
city: Vandoeuvre Les Nancy
country: France
city: Venissieux
country: France
city: Versailles
country: France
city: Vichy
country: France
city: Villefranche/saone
country: France
city: Villeneuve Sur Lot
country: France
Study officials:
References:
citation: Michallet M, Luporsi E, Soubeyran P, Amar NA, Boulanger V, Carreiro M, Dourthe LM, Labourey JL, Lepille D, Maloisel F, Mouysset JL, Nahon S, Narciso B, Nouyrigat P, Radji R, Sakek N, Albrand H; ORHEO study group. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study. BMC Cancer. 2014 Jul 10;14:503. doi: 10.1186/1471-2407-14-503.