Chemotherapy-induced Symptomatic AnemiaORHEONCT02140736
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
An observational study of Chemotherapy-induced Symptomatic Anemia and Solid Tumors, run by Hospira, now a wholly owned subsidiary of Pfizer at 172 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Symptomatic Anemia, Solid Tumors, Malignant Hemopathies
- What is being tested?
- Epoetin biosimilar
- How many people
- 2,333 participants
- Where
- 172 sitesFrance
- Study dates
- Sep 2009to 1 Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
172 sites in 1 country.
172 sites in 1 country
France172 sites
Study site
Agen, 47000
Study site
Aix-en-Provence, 13100
Study site
Aix-en-Provence, 13101
Study site
Aix-en-Provence, 13616
Study site
Ajaccio, 20176
Study site
Albi, 81000
Study site
Amboise, 37400
Study site
Amilly, 45200
Study site
Annecy, 74000
Study site
Antibes, 6606
Study site
Armentières, 59421
Study site
Arras, 62000
Study site
Arras, 62022
Study site
Aulnay-sous-Bois, 93602
Study site
Avignon, 84000
Study site
Avignon, 84082
Study site
Bayonne, 64100
Study site
Beauvais, 60021
Study site
Besançon, 25030
Study site
Béthune, 62400
Study site
Beuvry, 62660
Study site
Béziers, 34500
Study site
Blois, 41000
Study site
Bois-Guillaume, 76230
Study site
Bordeaux, 33000
Study site
Bordeaux, 33076
Study site
Bordeaux, 33300
Study site
Boulogne-sur-Mer, 62200
Study site
Brest, 29200
Study site
Brest, 29609
Study site
Bron, 69500
Study site
Caen, 14000
Study site
Caen, 14033
Study site
Cannes, 6401
Study site
Cannes, 6414
Study site
Carcassonne, 11000
Study site
Carcassonne, 11890
Study site
Castelnau-le-Lez, 34170
Study site
Challes-les-Eaux, 73190
Study site
Chalon/saonne, 71321
Study site
Chambéry, 73000
Study site
Chambéry, 73011
Study site
Cherbourg-octeville, 50100
Study site
Clermont-Ferrand, 63011
Study site
Colmar, 68000
Study site
Colmar, 68024
Study site
Compiègne, 60321
Study site
Créteil, 94000
Study site
Croix, 59963
Study site
Désertines, 3630
Study site
Dijon, 21079
Study site
Draguignan, 83007
Study site
Draguignan, 83300
Study site
Dunkirk, 59240
Study site
Évreux, 27025
Study site
Feurs, 42110
Study site
Foix, 9017
Study site
Fréjus, 83600
Study site
Fréjus, 83608
Study site
Freyming-Merlebach, 57804
Study site
Fryming Merle BACH, 57800
Study site
Gap, 5000
Study site
Gap, 5007
Study site
Grasse, 6135
Study site
Haguenau, 67500
Study site
Hyères, 83056
Study site
Hyères, 83400
Study site
La Roche-sur-Yon, 85925
Study site
La Rochelle, 17019
Study site
La Seyne-sur-Mer, 83500
Study site
La Tronche, 38700
Study site
Le Blanc-Mesnil, 93150
Study site
Le Mans, 72037
Study site
Lille, 59000
Study site
Lille, 59037
Study site
Limoges, 87042
Study site
Lyon, 69000
Study site
Lyon, 69365
Study site
Lyon, 69373
Study site
Lyon, 69424
Study site
Lyon, 69437
Study site
Mâcon, 71018
Study site
Mareuil LES MAUX, 77100
Study site
Marseille, 13004
Study site
Marseille, 13005
Study site
Marseille, 13006
Study site
Marseille, 13008
Study site
Marseille, 13009
Study site
Marseille, 13012
Study site
Marseille, 13015
Study site
Marseille, 13285
Study site
Marseille, 13385
Study site
Marseille, 13915
Study site
Meaux, 77100
Study site
Metz, 57038
Study site
Metz, 57077
Study site
Monaco, 98012
Study site
Mont-de-Marsan, 40024
Study site
Montargis, 45207
Study site
Montauban, 82013
Study site
Montbéliard, 25200
Study site
Montbéliard, 25209
Study site
Montfermeil, 93370
Study site
Montpellier, 34090
Study site
Montpellier, 34295
Study site
Morlaix, 29600
Study site
Moulins, 3006
Study site
Mulhouse, 68051
Study site
Mulhouse, 68067
Study site
Mulhouse, 68070
Study site
Nancy, 54100
Study site
Nantes, 44093
Study site
Nantes Saint Herblain, 44805
Study site
Narbonne, 11100
Study site
Nice, 6000
Study site
Nice, 6189
Study site
Nice, 6202
Study site
Nîmes, 30029
Study site
Nîmes, 30900
Study site
Niort, 79021
Study site
Nogent/Marne, 94130
Study site
Orléans, 45067
Study site
Paris, 75004
Study site
Paris, 75007
Study site
Paris, 75014
Study site
Paris, 75018
Study site
Paris, 75116
Study site
Perpignan, 66046
Study site
Pessac, 33604
Study site
Pierre-Bénite, 69495
Study site
Poitiers, 86021
Study site
Pontoise, 95300
Study site
Pringy, 74370
Study site
Pringy, 74374
Study site
Reims, 51100
Study site
Rennes, 35033
Study site
Rouen, 76000
Study site
Rouen, 76044
Study site
Rouen, 76100
Study site
Saint-Cloud, 92210
Study site
Saint-Gaudens, 31800
Study site
Saint-Germain-en-Laye, 78015
Study site
Saint-Germain-en-Laye, 78100
Study site
Saint-Herblain, 44805
Study site
Saint-Priest-en-Jarez, 42227
Study site
Saint-Quentin, 02321
Study site
Sainte-Feyre, 23000
Study site
Sélestat, 67604
Study site
Strasbourg, 67000
Study site
Strasbourg, 67065
Study site
Strasbourg, 67091
Study site
Strasbourg, 67098
Study site
Strasbourg, 67100
Study site
Talence, 33401
Study site
Tarbes, 65000
Study site
Thionville, 57100
Study site
Thonon-les-Bains, 74203
Study site
Toulon, 83041
Study site
Toulon, 83056
Study site
Toulon, 83100
Study site
Toulouse, 31059
Study site
Toulouse, 31076
Study site
Tours, 37044
Study site
Tremblay-en-France, 93290
Study site
Troyes, 10003
Study site
Valence, 26953
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vénissieux, 69200
Study site
Versailles, 78000
Study site
Vichy, 3201
Study site
Villefranche/saone, 69655
Study site
Villeneuve-sur-Lot, 47307
About this study
Official title: 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.
Read the 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.
- Conditions
- Chemotherapy-induced Symptomatic Anemia, Solid Tumors, Malignant Hemopathies, Lymphomas, Myelomas
- Being tested
- Epoetin biosimilar
- Keywords
- Chemotherapy-induced anemia, Epoetin biosimilar
- Medical subject headings
- Lymphoma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin biosimilarDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients with chemo-induced symptomatic anemia | Not described Receives: Drug: Epoetin biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change and corrected Hemoglobin levels
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
Measured: 6 months
Secondary outcomes (5)
Observe evolution of the biological indicators
Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
Measured: 6 months
Study the profiles of treated patients
Measured: 6 months
Assess the reasons for the prescriber's treatment regimens
Measured: 6 months
Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics
Measured: 6 months
Observation of the safety profiles of the Product (Epoetin Alfa)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startSep 2009
- Primary completionAug 2011
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Symptomatic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140736
- Sponsor's protocol ID
- 1_09.04.2009
- Other IDs
- 09.214
- Acronym
- ORHEO
- Status last verified
- Jul 2015
- First submitted
- 14 May 2014
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25011615
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
- ClinicalTrials.gov ID
- NCT02140736
- Acronym / sponsor ID
- ORHEO / 1_09.04.2009
- Conditions
- Chemotherapy-induced Symptomatic Anemia, Solid Tumors, Malignant Hemopathies, Lymphomas, Myelomas
- Keywords
- Chemotherapy-induced anemia, Epoetin biosimilar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,333 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chemo-induced symptomatic anemia | – | Drug: Epoetin biosimilar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin biosimilar | Drug | Patients with chemo-induced symptomatic anemia |
Primary outcome
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.
5 secondary outcomes
Observe evolution of the biological indicators
Time frame: 6 months
Study the profiles of treated patients
Time frame: 6 months
Assess the reasons for the prescriber's treatment regimens
Time frame: 6 months
Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics
Time frame: 6 months
Observation of the safety profiles of the Product (Epoetin Alfa)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 25011615Michallet 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
172 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-induced Symptomatic Anemia and Solid Tumors, run by Hospira, now a wholly owned subsidiary of Pfizer at 172 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 172 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change and corrected Hemoglobin levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.