Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00410696
First received: December 12, 2006
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

The primary objective of the study is to evaluate the efficacy and the safety of pegfilgrastim versus filgrastim, administered after high-dose chemotherapy and peripheral stem cell reinfusion.


Condition Intervention Phase
Hematological Neoplasms
Tumors
Drug: Filgrastim
Drug: Pegfilgrastim
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy With Peripheral Autologous Stem Cell Reinfusion in Patients With Hematological Neoplasms and Solid Tumors: Phase II Randomised Trial

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Duration of aplasia period [ Time Frame: At time of discharge from Unit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological reconstitution [ Time Frame: 1 year after transplantation ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: September 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Filgrastim
Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)
Drug: Filgrastim
5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
Other Name: Granulokine
Experimental: Pegfilgrastim
Pegfilgrastim administered the day after autologous stem-cell reinfusion
Drug: Pegfilgrastim
6 mg/day sc at day +1
Other Name: Neulasta

Detailed Description:

Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hematological neoplasms or solid tumors candidable to high-dose chemotherapy with autologous peripheral stem cell reinfusion
  • Adequate organ function
  • Written informed consent.

Exclusion Criteria:

  • Use of other experimental drugs
  • Active infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410696

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
Investigators
Study Director: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00410696     History of Changes
Other Study ID Numbers: ONC-2006-001, EUDRACT 2006-001409-27
Study First Received: December 12, 2006
Last Updated: June 28, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:
High-dose chemotherapy
Growth factor
Pegfilgrastim

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014