ORHEO: Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
Sponsor
Hospira, now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02140736
Collaborator
(none)
2,333
188
23
12.4
0.5
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Observational
Actual Enrollment
:
2333 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
Study Start Date
:
Sep 1, 2009
Actual Primary Completion Date
:
Aug 1, 2011
Actual Study Completion Date
:
Aug 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with chemo-induced symptomatic anemia
|
Drug: Epoetin biosimilar
|
Outcome Measures
Primary Outcome Measures
- Change and corrected Hemoglobin levels [6 months]
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
Secondary Outcome Measures
- Observe evolution of the biological indicators [6 months]
Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
- Study the profiles of treated patients [6 months]
- Assess the reasons for the prescriber's treatment regimens [6 months]
- Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics [6 months]
- Observation of the safety profiles of the Product (Epoetin Alfa) [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Agen | France | 47000 | ||
| 2 | Aix En Provence Cedex | France | 13616 | ||
| 3 | Aix En Provence | France | 13100 | ||
| 4 | Aix En Provence | France | 13101 | ||
| 5 | Aix En Provence | France | 13616 | ||
| 6 | Ajaccio Cedex | France | 20176 | ||
| 7 | Albi | France | 81000 | ||
| 8 | Amboise | France | 37400 | ||
| 9 | Amilly | France | 45200 | ||
| 10 | Annecy | France | 74000 | ||
| 11 | Antibes | France | 6606 | ||
| 12 | Armentieres | France | 59421 | ||
| 13 | Arras Cedex | France | 62022 | ||
| 14 | Arras | France | 62000 | ||
| 15 | AULNAY SOUS BOIS Cedex | France | 93602 | ||
| 16 | Avignon Cedex 2 | France | 84082 | ||
| 17 | Avignon | France | 84000 | ||
| 18 | Bayonne | France | 64100 | ||
| 19 | Beauvais | France | 60021 | ||
| 20 | Besancon Cedex | France | 25030 | ||
| 21 | Besancon | France | 25030 | ||
| 22 | Bethune | France | 62400 | ||
| 23 | Beuvry | France | 62660 | ||
| 24 | Beziers | France | 34500 | ||
| 25 | Blois | France | 41000 | ||
| 26 | Bois-guillaume | France | 76230 | ||
| 27 | Bordeaux Cedex | France | 33076 | ||
| 28 | Bordeaux | France | 33000 | ||
| 29 | Bordeaux | France | 33300 | ||
| 30 | Boulogne Sur Mer | France | 62200 | ||
| 31 | Brest Cedex | France | 29609 | ||
| 32 | Brest | France | 29200 | ||
| 33 | Brest | France | 29609 | ||
| 34 | Bron | France | 69500 | ||
| 35 | Caen | France | 14000 | ||
| 36 | Caen | France | 14033 | ||
| 37 | Cannes | France | 6401 | ||
| 38 | Cannes | France | 6414 | ||
| 39 | Carcassonne Cedex 9 | France | 11890 | ||
| 40 | Carcassonne | France | 11000 | ||
| 41 | Castelnau Le Lez | France | 34170 | ||
| 42 | Challes Les Eaux | France | 73190 | ||
| 43 | Chalon/saonne | France | 71321 | ||
| 44 | Chambery Cedex | France | 73011 | ||
| 45 | Chambery | France | 73000 | ||
| 46 | Chambery | France | 73011 | ||
| 47 | Cherbourg-octeville | France | 50100 | ||
| 48 | Clermont Ferrand Cedex 1 | France | 63011 | ||
| 49 | Colmar Cedex | France | 68024 | ||
| 50 | Colmar | France | 68000 | ||
| 51 | Colmar | France | 68024 | ||
| 52 | Compiegne | France | 60321 | ||
| 53 | Creteil | France | 94000 | ||
| 54 | Croix Cedex | France | 59963 | ||
| 55 | Croix | France | 59963 | ||
| 56 | Desertines | France | 3630 | ||
| 57 | Dijon Cedex | France | 21079 | ||
| 58 | Draguignan Cedex | France | 83007 | ||
| 59 | Draguignan Cedex | France | 83300 | ||
| 60 | Draguignan | France | 83007 | ||
| 61 | Dunkerque | France | 59240 | ||
| 62 | Evreux | France | 27025 | ||
| 63 | Feurs | France | 42110 | ||
| 64 | Foix Cedex | France | 9017 | ||
| 65 | Frejus Cedex | France | 83608 | ||
| 66 | Frejus | France | 83600 | ||
| 67 | Frejus | France | 83608 | ||
| 68 | Freyming Merlebach | France | 57804 | ||
| 69 | Fryming Merle Bach | France | 57800 | ||
| 70 | Gap Cedex | France | 5007 | ||
| 71 | GAP | France | 5000 | ||
| 72 | Grasse | France | 6135 | ||
| 73 | Haguenau | France | 67500 | ||
| 74 | Hyeres | France | 83056 | ||
| 75 | Hyeres | France | 83400 | ||
| 76 | La Roche Sur Yon Cedex 9 | France | 85925 | ||
| 77 | La Rochelle Cedex 1 | France | 17019 | ||
| 78 | La Seyne Sur Mer | France | 83500 | ||
| 79 | La Tronche | France | 38700 | ||
| 80 | Le Blanc Mesnil | France | 93150 | ||
| 81 | Le Mans Cedex 9 | France | 72037 | ||
| 82 | Lille Cedex | France | 59000 | ||
| 83 | Lille | France | 59000 | ||
| 84 | Lille | France | 59037 | ||
| 85 | Limoges Cedex | France | 87042 | ||
| 86 | Lyon Cedex 07 | France | 69365 | ||
| 87 | Lyon Cedex 8 | France | 69373 | ||
| 88 | Lyon | France | 69000 | ||
| 89 | Lyon | France | 69424 | ||
| 90 | Lyon | France | 69437 | ||
| 91 | Macon Cedex | France | 71018 | ||
| 92 | Mareuil Les Maux | France | 77100 | ||
| 93 | Marseille Cedex 08 | France | 13285 | ||
| 94 | Marseille Cedex 20 | France | 13915 | ||
| 95 | Marseille | France | 13004 | ||
| 96 | Marseille | France | 13005 | ||
| 97 | Marseille | France | 13006 | ||
| 98 | Marseille | France | 13008 | ||
| 99 | Marseille | France | 13009 | ||
| 100 | Marseille | France | 13012 | ||
| 101 | Marseille | France | 13015 | ||
| 102 | Marseille | France | 13385 | ||
| 103 | Meaux | France | 77100 | ||
| 104 | Metz Cedex 01 | France | 57038 | ||
| 105 | Metz Cedex 3 | France | 57077 | ||
| 106 | Monaco | France | 98012 | ||
| 107 | Mont de Marsan | France | 40024 | ||
| 108 | Montargis Cedex | France | 45207 | ||
| 109 | Montauban | France | 82013 | ||
| 110 | Montbeliard | France | 25200 | ||
| 111 | Montbeliard | France | 25209 | ||
| 112 | Montfermeil | France | 93370 | ||
| 113 | Montpellier Cedex 5 | France | 34295 | ||
| 114 | Montpellier | France | 34090 | ||
| 115 | Montpellier | France | 34295 | ||
| 116 | Morlaix | France | 29600 | ||
| 117 | Moulins | France | 3006 | ||
| 118 | Mulhouse Cedex | France | 68067 | ||
| 119 | Mulhouse Cedex | France | 68070 | ||
| 120 | Mulhouse | France | 68051 | ||
| 121 | Mulhouse | France | 68070 | ||
| 122 | Nancy | France | 54100 | ||
| 123 | Nantes St Herblain | France | 44805 | ||
| 124 | Nantes | France | 44093 | ||
| 125 | Narbonne | France | 11100 | ||
| 126 | Nice Cedex 03 | France | 6202 | ||
| 127 | Nice Cedex 2 | France | 6189 | ||
| 128 | Nice | France | 6000 | ||
| 129 | Nice | France | 6189 | ||
| 130 | Nimes | France | 30900 | ||
| 131 | Niort | France | 79021 | ||
| 132 | Nogent/Marne | France | 94130 | ||
| 133 | Nîmes Cedex | France | 30029 | ||
| 134 | Orleans | France | 45067 | ||
| 135 | Paris | France | 75004 | ||
| 136 | Paris | France | 75007 | ||
| 137 | Paris | France | 75014 | ||
| 138 | Paris | France | 75018 | ||
| 139 | Paris | France | 75116 | ||
| 140 | Perpignan Cedex | France | 66046 | ||
| 141 | Pessac | France | 33604 | ||
| 142 | Pierre Benite Cedex | France | 69495 | ||
| 143 | Poitiers | France | 86021 | ||
| 144 | Pontoise | France | 95300 | ||
| 145 | Pringy Cedex | France | 74374 | ||
| 146 | Pringy | France | 74370 | ||
| 147 | Reims | France | 51100 | ||
| 148 | Rennes Cedex 9 | France | 35033 | ||
| 149 | Rouen | France | 76000 | ||
| 150 | Rouen | France | 76044 | ||
| 151 | Rouen | France | 76100 | ||
| 152 | Saint Cloud | France | 92210 | ||
| 153 | Saint Gaudens | France | 31800 | ||
| 154 | Saint Germain En Laye | France | 78015 | ||
| 155 | Saint Quentin | France | 02321 | ||
| 156 | Sainte Feyre | France | 23000 | ||
| 157 | Selestat | France | 67604 | ||
| 158 | St Cloud | France | 92210 | ||
| 159 | St Germain En Laye | France | 78100 | ||
| 160 | St Germain | France | 78100 | ||
| 161 | St HERBLAIN CEDEX | France | 44805 | ||
| 162 | St Priest En Jarez Cedex | France | 42227 | ||
| 163 | Strasbourg Cedex 2 | France | 67098 | ||
| 164 | Strasbourg Cedex | France | 67065 | ||
| 165 | Strasbourg Cedex | France | 67091 | ||
| 166 | Strasbourg | France | 67000 | ||
| 167 | Strasbourg | France | 67098 | ||
| 168 | Strasbourg | France | 67100 | ||
| 169 | Talence Cedex | France | 33401 | ||
| 170 | Talence | France | 33401 | ||
| 171 | Tarbes | France | 65000 | ||
| 172 | Thionville | France | 57100 | ||
| 173 | Thonon-les-bains | France | 74203 | ||
| 174 | Toulon Cedex 9 | France | 83041 | ||
| 175 | Toulon | France | 83056 | ||
| 176 | Toulon | France | 83100 | ||
| 177 | Toulouse Cedex 9 | France | 31059 | ||
| 178 | Toulouse | France | 31076 | ||
| 179 | Tours Cedex 9 | France | 37044 | ||
| 180 | Tremblay En France | France | 93290 | ||
| 181 | Troyes | France | 10003 | ||
| 182 | Valence Cedex | France | 26953 | ||
| 183 | Vandoeuvre Les Nancy | France | 54511 | ||
| 184 | Venissieux | France | 69200 | ||
| 185 | Versailles | France | 78000 | ||
| 186 | Vichy | France | 3201 | ||
| 187 | Villefranche/saone | France | 69655 | ||
| 188 | Villeneuve Sur Lot | France | 47307 |
Sponsors and Collaborators
- Hospira, now a wholly owned subsidiary of Pfizer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT02140736
Other Study ID Numbers:
- 1_09.04.2009
- 09.214
First Posted:
May 16, 2014
Last Update Posted:
Mar 20, 2017
Last Verified:
Jul 1, 2015
Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer
Additional relevant MeSH terms: