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The Compatibility of Nivestim(TM) Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases


N/A
N/A
N/A
Open (Enrolling)
Both
Solid Tumor, Malignant Hematological Tumor, Primary or Secondary Prophylactic Treatment

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Trial Information

The Compatibility of Nivestim(TM) Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of hospitalizations

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

VENICE

NCT ID:

NCT01627990

Start Date:

July 2011

Completion Date:

March 2014

Related Keywords:

  • Solid Tumor
  • Malignant Hematological Tumor
  • Primary or Secondary Prophylactic Treatment
  • cytotoxic chemotherapy
  • G-CSF
  • Solid tumor
  • Malignant hematological tumor
  • Hematologic Neoplasms

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