NCT Number: NCT02140736
Epoetin Alfa Biosimilar in the Management of Chemotherapy-Induced Symptomatic Anemia in Haematology and Oncology
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Agen, France
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
Observe evolution of the biological indicators
Time frame: 6 months
Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation
-
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
Sponsors and collaborators
Lead sponsor
Hospira, now a wholly owned subsidiary of Pfizer
Industry
Registry information
Official study title
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
Acronym: ORHEO
Important dates
- Study start
- 2009
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- May 16, 2014
- Registry last updated
- Feb 28, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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