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

Solid Tumors Clinical Trial

— ORHEO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02140736
• Other study ID #: 1_09.04.2009
• Secondary ID: 09.214
• Status: Completed
• Start date: September 2009
• Est. completion date: August 1, 2011

Study information

• Verified date: July 2015
• Source: Hospira, now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2333
• Est. completion date: August 1, 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Chemotherapy-induced Symptomatic Anemia
• Lymphomas
• Malignant Hemopathies
• Myelomas
• Solid Tumors

Intervention

Drug:
• Epoetin biosimilar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change and corrected Hemoglobin levels	Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.	6 months
Secondary	Observe evolution of the biological indicators	Observe evolution of the biological indicators: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation	6 months
Secondary	Study the profiles of treated patients		6 months
Secondary	Assess the reasons for the prescriber's treatment regimens		6 months
Secondary	Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics		6 months
Secondary	Observation of the safety profiles of the Product (Epoetin Alfa)		6 months