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

Hospira

Status: Completed

Conditions: Lymphomas; Malignant Hemopathies; Solid Tumors; Chemotherapy-induced Symptomatic Anemia; Myelomas

Treatments: Drug: Epoetin biosimilar

Study type: Observational

Funder types: Industry

Identifiers

NCT02140736

09.214 (Other Identifier)

1_09.04.2009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,333 participants in 1 patient group

Patients with chemo-induced symptomatic anemia

Treatment:

Drug: Epoetin biosimilar