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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01459653
First received: August 30, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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.


Condition
Febrile Neutropenia
Cancer
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: 1500
Study Start Date: March 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Only 1 group
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

  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

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

Criteria

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 ClinicalTrials.gov identifier: NCT01459653

Locations
Czech Republic
Nemocnice Znojmo
Znojmo, Czech Republic, 66902
France
Hôpital Européen Georges Pompidou - Service Oncologie Médicale
Paris, France, 75908
Germany
Universitaetsklinik Hamburg-Eppendorf, Med. Klinik II Onkologie, Haematologie
Hamburg, Germany, 20246
Italy
Azienda Ospedaliero Universitaria "San Giovanni Battista di Torino"
Torino, Italy, 10126
Poland
SPSK1 Klinika Hematologii
Lublin, Poland, 20-081
Romania
Centrul de Diagnostic si Tratament Euromedic Fundeni
Bucuresti, Romania, 022328
Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Switzerland
IMO Clinique de Genolier
Genolier, Switzerland, 1272
United Kingdom
The Rotherham NHS Foundation Trust - Dept. of Haematology
Rotherham, United Kingdom, S60 2UD
Sponsors and Collaborators
Sandoz
Investigators
Study Director: Matthew Turner, PhD Sandoz
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01459653     History of Changes
Other Study ID Numbers: Monitor-GCSF, EP-502
Study First Received: August 30, 2011
Last Updated: October 6, 2014
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
cancer
chemotherapy,
primary prophylaxis
secondary prophylaxis
filgrastim
granulocyte colony stimulating factor
observational study
noninterventional study

Additional relevant MeSH terms:
Breast Neoplasms
Chemotherapy-Induced Febrile Neutropenia
Febrile Neutropenia
Fever
Lymphoma, B-Cell
Multiple Myeloma
Neoplasms, Plasma Cell
Neutropenia
Ovarian Neoplasms
Prostatic Neoplasms
Urinary Bladder Neoplasms
Adnexal Diseases
Agranulocytosis
Blood Protein Disorders
Body Temperature Changes
Breast Diseases
Cardiovascular Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukocyte Disorders

ClinicalTrials.gov processed this record on November 25, 2014