Biosimilar RetacritTM (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01626547
First received: June 7, 2012
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with RetacritTM to correct haemoglobin levels.


Condition
Chemotherapy-induced Symptomatic Anaemia
Solid Tumors
Malignant Lymphomas
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biosimilar RetacritTM (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • Change and corrected Hemoglobin levels [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.


Secondary Outcome Measures:
  • Observation of blood value development [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation


Biospecimen Retention:   Samples With DNA

Concentrations of haemoglobin, thrombocytes, leukocytes, neutrophil and CRP are represented across time (v1, 2 and 3)


Enrollment: 240
Study Start Date: October 2010
Study Completion Date: July 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chemotherapy-induced symptomatic anaemia. Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.

Criteria

Inclusion Criteria:

  • Patients are 18 years of age or over.
  • Patients present with chemotherapy-induced symptomatic anaemia.
  • Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy
  • Patients can be recruited at any time (from the first to the final chemotherapy cycle.)
  • Patients would be suited for a course of treatment with RetacritTM (epoetin zeta)

Exclusion Criteria:

  • Patients are not undergoing chemotherapy.
  • Patients have already taken part in a RetacritTM study.
  • The patients have contraindications to Retacrit(TM)
  • Patients have hypersensitivity to the active principle or to one of the excipients.
  • The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA)
  • Uncontrollable hypertension
  • An adequate prophylaxis against thrombosis is not practicable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626547

Locations
Germany
"Medizinisches Versorgungszentrum
Berlin, Germany, 10407
MediOnko-Institut GRR
Berlin, Germany, 10367
Onkoplan GmbH/ Onkologische Schwerpunktpraxis
Berlin, Germany, 13055
Fachärzte für Innere Medizin - Hämatologie u. Internistische Onkologie
Berlin, Germany, 12627
"Facharzt für Innere Medizin
Borken, Germany, 46325
Frauenarzt
Brandenburg, Germany, 14770
Poliklinik GmbH Chemnitz
Chemnitz, Germany, 09113
Fachärztin für Innere Medizin / Hämatologie / Onkologie
Cottbus, Germany, 03046
"Facharzt für Innere Medizin/
Dresden, Germany, 1307
"Facharzt für Innere Medizin Hamatologie und Internistische Onkologie
Eisenach, Germany, 99817
Internist / Hämatologe / Intern. Onkologie
Frankenthal, Germany, 67227
Internist - Hämatologe - Onkologe
Garbsen, Germany, 30827
Hämatologie und Onkologie
Gosiar, Germany, 38642
Medizinisches Studien- und Dokumentationszentrum
Groitzsch, Germany, 04539
FA für Innere Medizin - Hämatologie - Internistische Onkologie
Halberstadt, Germany, 38820
MediProjekt Ges. f. Medizinstatistik und Projektentwicklung
Hannover, Germany, 30171
Internist - Hämatologe - Onkologe
Hannover, Germany, 30625
ODZ-Petersen GmbH
Heidenheim, Germany, 89518
DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG
Herne, Germany, 44632
"Medizinisches Versorgungszentrum MP Saaletal GmbH
Jena, Germany, 07743
OnkoMed GbR
Krefeld, Germany, 47805
Facharzle fur Innere Medizin - Hamatologie u. Intemistische Onkologie
Munchen, Germany, 81479
Facharzte fur Innere Medizin - Hamatologie u. Intermistische Onkologie - Bluttransfusionswesen
Munchen, Germany, 80638
Gemeinschaftspraxis für Hämatologie und Onkologie
Munster, Germany, 48149
Tumorzentrum Niederrhein GmbH
Neuss, Germany, 41462
Facharzt für Frauenheilkunde und Geburtshilfe
Oberhausen, Germany, 46045
Überörtliche Gemeinschaftspraxis
Oberhausen, Germany, 46145
Medizinisches Versorgungszentrum Onkologische Schwerpunktpraxis
Olpe, Germany, 57462
Fachärztin für Frauenheilkunde und Geburtshilfe
Oranienburg, Germany, 16515
Medizinisches Versorgungszentrum GbR
Paradiese, Germany, 59494
FA f. Innere Medizin, Onkologie und Endokrinologie
Parchim, Germany, 19370
Facharzt für Innere Medizin - Medikamentöse Tumortheraphie
Remscheid, Germany, 42859
Frauenarzt
Rodgau, Germany, 63110
"FA f. Frauenheilkunde und Geburtshilfe SP Gynakologische Onkologie
Stralsund, Germany, 18435
Praxis fur Hamatologie und Internistische Onkologie
Velbert, Germany, 42551
Facharzt für Innere Medizin Hamatologie und Onkologie
Verden, Germany, 27283
Onkologische Schwerpunktpraxis Hamatologie und Onkologie
VS-Villingen, Germany, 78050
Sponsors and Collaborators
Hospira, Inc.
  More Information

Publications:
Responsible Party: Hospira, Inc.
ClinicalTrials.gov Identifier: NCT01626547     History of Changes
Other Study ID Numbers: ORHEO
Study First Received: June 7, 2012
Last Updated: August 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hospira, Inc.:
symptomatic anameia

Additional relevant MeSH terms:
Anemia
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 27, 2014