Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)

This study has been completed.
Information provided by (Responsible Party):
Sandoz Identifier:
First received: August 30, 2011
Last updated: March 12, 2015
Last verified: March 2015

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically with filgrastim biosimilar, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

Febrile Neutropenia
Breast Cancer
Ovarian Cancer
Lung Cancer
Prostate Cancer
Multiple Myeloma
Bladder Cancer
B-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.

Resource links provided by NLM:

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Absolute neutrophil count (ANC) [ Time Frame: 6 months, 6 cycles of chemotharapy ] [ Designated as safety issue: No ]
    Describe intraindividual changes in ANC.

Secondary Outcome Measures:
  • Cohort identification and differentiation [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: No ]
    Patient profiles based on medical history, concomitant comorbid conditions and current clinical status.

  • Nonresponder analyses [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: Yes ]

    Patient- and center-level variables between patients who had:

    • chemotherapy dose delays or reductions,
    • surgery delays or cancellations, and
    • radiotherapy delays, dose reductions or cancellations vs no such events and
    • patients who died vs. survived during the course of prophylaxis with filgrastim biosimilar in all patients and those with break-through FN episodes.

Enrollment: 1496
Study Start Date: March 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Only 1 group
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.


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

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for febrile neutropenia.


Inclusion Criteria:

  • Male or female adults (age > / = 18 years)
  • Diagnosed with one of the following types and stages of tumors: stage III or IV breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large B-cell lymphoma; multiple myeloma.
  • Planned to receive primary prophylaxis with filgrastim biosimilar at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar irrespective of chemotherapy cycle.
  • Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar label.
  • Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
  • Informed written consent to participate in the study by patients or their legal guardian.

Exclusion Criteria:

  • Patients with myeloid malignancies, with the exception of multiple myeloma.
  • Sensitivity to filgrastim biosimilar or any other CSF.
  • Hypersensitivity to E. coli-derived proteins.
  • Radiotherapy to ≥ 20% of total body bone.
  • Infection within two weeks of starting current line of chemotherapy.
  • Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
  • Patients with willfully negligent nonadherence to their cancer treatment.
  • Use of any investigational agent in the 30 days prior to enrollment.
  • Women of childbearing potential not using the contraception method(s) described above.
  • Women who are breastfeeding.
  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 identifier: NCT01459653

  Show 120 Study Locations
Sponsors and Collaborators
Study Chair: Sandoz Biopharmaceuticals Sandoz Biopharmaceuticals
  More Information

No publications provided

Responsible Party: Sandoz Identifier: NCT01459653     History of Changes
Other Study ID Numbers: EP06-502
Study First Received: August 30, 2011
Last Updated: March 12, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Romania: National Medicines Agency
Czech Republic: State Institute for Drug Control

Keywords provided by Sandoz:
Febrile neutropenia
primary prophylaxis
secondary prophylaxis
granulocyte colony stimulating factor
observational study
noninterventional study

Additional relevant MeSH terms:
Chemotherapy-Induced Febrile Neutropenia
Febrile Neutropenia
Lymphoma, B-Cell
Multiple Myeloma
Blood Protein Disorders
Body Temperature Changes
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukocyte Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Signs and Symptoms
Vascular Diseases
Adjuvants, Immunologic
Immunologic Factors processed this record on July 01, 2015