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
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: 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 July 23, 2014