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Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410696
First Posted: December 13, 2006
Last Update Posted: July 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
  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
Intervention Model: Parallel Assignment
Masking: None (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 Armando Santoro, MD, Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Duration of aplasia period [ Time Frame: At time of discharge from Unit ]

Secondary Outcome Measures:
  • Immunological reconstitution [ Time Frame: 1 year after transplantation ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: December 12, 2006
First Posted: December 13, 2006
Last Update Posted: July 1, 2013
Last Verified: June 2013

Keywords provided by Armando Santoro, MD, 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