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

Completed

• Conditions: Chemotherapy-induced Symptomatic Anemia; Lymphomas; Myelomas; Solid Tumors; Malignant Hemopathies
• Interventions: Drug: Epoetin biosimilar

• Registration Number: NCT02140736
• Lead Sponsor: Hospira, now a wholly owned subsidiary of Pfizer

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.

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2011-08
• Study Completion: 2011-08-01
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-16
• Status Verified: 2015-07
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2333

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with chemo-induced symptomatic anemia	Epoetin biosimilar	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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