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

February 26, 2024 updated by: Hospira, now a wholly owned subsidiary of Pfizer

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with chemo-induced symptomatic anemia
Drug: Epoetin biosimilar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospira, now a wholly owned subsidiary of Pfizer

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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