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Nivestim(TM) in Treatment of Malignant Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hospira, Inc.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT01627990
First received: June 7, 2012
Last updated: July 7, 2014
Last verified: July 2014

June 7, 2012
July 7, 2014
July 2011
December 2013   (final data collection date for primary outcome measure)
Number of hospitalizations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Any incidence of hospitalization due to febrile neutropenia and/or infection will be evaluated. Individual cases will be reported and documented on SAE forms by the repsonsible physician.
Same as current
Complete list of historical versions of study NCT01627990 on ClinicalTrials.gov Archive Site
  • Number of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Any hospitalization regardless of the correlation to febrile neutropenia and/or infection and adverse events will be reported and documented on teh AE form in teh respective CRF of teh participants.
  • Changes to efficacy parameters from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    Description of the efficacy of treatment with Nivestim(TM) which includes the following parameters:

    • Duration of neutropenia
    • Incidence of febrile neutropenia
    • Frequency of infection
    • Delay in chemotherapy cycles due to neutropenia
    • Reduction in chemotherapy doses due to neutropenia
    • Assessment of patient
Same as current
Not Provided
Not Provided
 
Nivestim(TM) in Treatment of Malignant Diseases
The Compatibility of Nivestim(TM) Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).

To observe the tolerability, safety and efficacy of preventative treatment using NivestimTM in patients receiving cytotoxic chemotherapy for cancer.

To investigate the description of the characteristics of patients being treated with NivestimTM, the treatment modalities using NivestimTM in the daily Routine, to investigate the description of the characteristics of the participating Physicians and to determine the general prescription practices of these physicians with regard to G-CSF.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
  • CD34+ cell count in peripheral blood (low/high at Visit 1)
  • Concentrations of haemoglobin, thrombocytes, leukocytes, neutrophil and CRP are represented across time (v1, 2 and 3)
Non-Probability Sample

Children and adult patients with a solid tumor or a malignant haematological tumor due to under go prophylatic treatment using Nivestim/

  • Solid Tumor
  • Malignant Hematological Tumor
  • Primary or Secondary Prophylactic Treatment
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
July 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No age limit
  • Declaration of informed consent signed by patient or legal guardian
  • Patients with a solid tumour or with a malignant haematological tumour
  • Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
  • Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using NivestimTM, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced FN.

Exclusion Criteria:

  • Patients with chronic myeloid leukaemia (CML) or with myelodysplastic
  • Syndrome (MDS)
  • Patients who are hypersensitive to the active substance or to one of the
  • Excipients of NivestimTM
  • Patients not undergoing chemotherapy
  • Patients being treated curatively with G-CSF
Both
Not Provided
No
Contact: Rene Meissner ++49-89-43-7777-126 rene.meissner@hospira.com
Germany
 
NCT01627990
VENICE
No
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP