Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology (ORHEO)

Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

2333

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

      • AULNAY SOUS BOIS Cedex, France, 93602
      • Agen, France, 47000
      • Aix En Provence, France, 13616
      • Aix En Provence, France, 13100
      • Aix En Provence, France, 13101
      • Aix En Provence Cedex, France, 13616
      • Ajaccio Cedex, France, 20176
      • Albi, France, 81000
      • Amboise, France, 37400
      • Amilly, France, 45200
      • Annecy, France, 74000
      • Antibes, France, 6606
      • Armentieres, France, 59421
      • Arras, France, 62000
      • Arras Cedex, France, 62022
      • Avignon, France, 84000
      • Avignon Cedex 2, France, 84082
      • Bayonne, France, 64100
      • Beauvais, France, 60021
      • Besancon, France, 25030
      • Besancon Cedex, France, 25030
      • Bethune, France, 62400
      • Beuvry, France, 62660
      • Beziers, France, 34500
      • Blois, France, 41000
      • Bois-guillaume, France, 76230
      • Bordeaux, France, 33000
      • Bordeaux, France, 33300
      • Bordeaux Cedex, France, 33076
      • Boulogne Sur Mer, France, 62200
      • Brest, France, 29609
      • Brest, France, 29200
      • Brest Cedex, France, 29609
      • Bron, France, 69500
      • Caen, France, 14000
      • Caen, France, 14033
      • Cannes, France, 6401
      • Cannes, France, 6414
      • Carcassonne, France, 11000
      • Carcassonne Cedex 9, France, 11890
      • Castelnau Le Lez, France, 34170
      • Challes Les Eaux, France, 73190
      • Chalon/saonne, France, 71321
      • Chambery, France, 73000
      • Chambery, France, 73011
      • Chambery Cedex, France, 73011
      • Cherbourg-octeville, France, 50100
      • Clermont Ferrand Cedex 1, France, 63011
      • Colmar, France, 68024
      • Colmar, France, 68000
      • Colmar Cedex, France, 68024
      • Compiegne, France, 60321
      • Creteil, France, 94000
      • Croix, France, 59963
      • Croix Cedex, France, 59963
      • Desertines, France, 3630
      • Dijon Cedex, France, 21079
      • Draguignan, France, 83007
      • Draguignan Cedex, France, 83007
      • Draguignan Cedex, France, 83300
      • Dunkerque, France, 59240
      • Evreux, France, 27025
      • Feurs, France, 42110
      • Foix Cedex, France, 9017
      • Frejus, France, 83608
      • Frejus, France, 83600
      • Frejus Cedex, France, 83608
      • Freyming Merlebach, France, 57804
      • Fryming Merle BACH, France, 57800
      • GAP, France, 5000
      • Gap Cedex, France, 5007
      • Grasse, France, 6135
      • Haguenau, France, 67500
      • Hyeres, France, 83400
      • Hyeres, France, 83056
      • La Roche Sur Yon Cedex 9, France, 85925
      • La Rochelle Cedex 1, France, 17019
      • La Seyne Sur Mer, France, 83500
      • La Tronche, France, 38700
      • Le Blanc Mesnil, France, 93150
      • Le Mans Cedex 9, France, 72037
      • Lille, France, 59037
      • Lille, France, 59000
      • Lille Cedex, France, 59000
      • Limoges Cedex, France, 87042
      • Lyon, France, 69437
      • Lyon, France, 69000
      • Lyon, France, 69424
      • Lyon Cedex 07, France, 69365
      • Lyon Cedex 8, France, 69373
      • Macon Cedex, France, 71018
      • Mareuil LES MAUX, France, 77100
      • Marseille, France, 13009
      • Marseille, France, 13385
      • Marseille, France, 13006
      • Marseille, France, 13005
      • Marseille, France, 13008
      • Marseille, France, 13012
      • Marseille, France, 13015
      • Marseille, France, 13004
      • Marseille Cedex 08, France, 13285
      • Marseille Cedex 20, France, 13915
      • Meaux, France, 77100
      • Metz Cedex 01, France, 57038
      • Metz Cedex 3, France, 57077
      • Monaco, France, 98012
      • Mont de Marsan, France, 40024
      • Montargis Cedex, France, 45207
      • Montauban, France, 82013
      • Montbeliard, France, 25209
      • Montbeliard, France, 25200
      • Montfermeil, France, 93370
      • Montpellier, France, 34295
      • Montpellier, France, 34090
      • Montpellier Cedex 5, France, 34295
      • Morlaix, France, 29600
      • Moulins, France, 3006
      • Mulhouse, France, 68070
      • Mulhouse, France, 68051
      • Mulhouse Cedex, France, 68070
      • Mulhouse Cedex, France, 68067
      • Nancy, France, 54100
      • Nantes, France, 44093
      • Nantes Saint Herblain, France, 44805
      • Narbonne, France, 11100
      • Nice, France, 6000
      • Nice, France, 6189
      • Nice Cedex 03, France, 6202
      • Nice Cedex 2, France, 6189
      • Nimes, France, 30900
      • Niort, France, 79021
      • Nogent/Marne, France, 94130
      • Nîmes Cedex, France, 30029
      • Orleans, France, 45067
      • Paris, France, 75018
      • Paris, France, 75014
      • Paris, France, 75007
      • Paris, France, 75004
      • Paris, France, 75116
      • Perpignan Cedex, France, 66046
      • Pessac, France, 33604
      • Pierre Benite Cedex, France, 69495
      • Poitiers, France, 86021
      • Pontoise, France, 95300
      • Pringy, France, 74370
      • Pringy Cedex, France, 74374
      • Reims, France, 51100
      • Rennes Cedex 9, France, 35033
      • Rouen, France, 76000
      • Rouen, France, 76100
      • Rouen, France, 76044
      • Saint Cloud, France, 92210
      • Saint Gaudens, France, 31800
      • Saint Germain En Laye, France, 78015
      • Saint Quentin, France, 02321
      • Sainte Feyre, France, 23000
      • Selestat, France, 67604
      • St Cloud, France, 92210
      • St Germain, France, 78100
      • St Germain En Laye, France, 78100
      • St HERBLAIN CEDEX, France, 44805
      • St Priest En Jarez Cedex, France, 42227
      • Strasbourg, France, 67098
      • Strasbourg, France, 67100
      • Strasbourg, France, 67000
      • Strasbourg Cedex, France, 67091
      • Strasbourg Cedex, France, 67065
      • Strasbourg Cedex 2, France, 67098
      • Talence, France, 33401
      • Talence Cedex, France, 33401
      • Tarbes, France, 65000
      • Thionville, France, 57100
      • Thonon-les-bains, France, 74203
      • Toulon, France, 83056
      • Toulon, France, 83100
      • Toulon Cedex 9, France, 83041
      • Toulouse, France, 31076
      • Toulouse Cedex 9, France, 31059
      • Tours Cedex 9, France, 37044
      • Tremblay En France, France, 93290
      • Troyes, France, 10003
      • Valence Cedex, France, 26953
      • Vandoeuvre Les Nancy, France, 54511
      • Venissieux, France, 69200
      • Versailles, France, 78000
      • Vichy, France, 3201
      • Villefranche/saone, France, 69655
      • Villeneuve Sur Lot, France, 47307

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with chemo-induced symptomatic anemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change and corrected Hemoglobin levels
Time Frame: 6 months
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe evolution of the biological indicators
Time Frame: 6 months
Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
6 months
Study the profiles of treated patients
Time Frame: 6 months
6 months
Assess the reasons for the prescriber's treatment regimens
Time Frame: 6 months
6 months
Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics
Time Frame: 6 months
6 months
Observation of the safety profiles of the Product (Epoetin Alfa)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

September 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 14, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimated)

May 16, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1_09.04.2009
  • 09.214 (Other Identifier: CCTIRS)

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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