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Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

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. Identifier: NCT00410696
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : July 1, 2013
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

Brief Summary:
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 or disease Intervention/treatment Phase
Hematological Neoplasms Tumors Drug: Filgrastim Drug: Pegfilgrastim Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00410696

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas Identifier: NCT00410696     History of Changes
Other Study ID Numbers: ONC-2006-001
EUDRACT 2006-001409-27
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013
Keywords provided by Armando Santoro, MD, Istituto Clinico Humanitas:
High-dose chemotherapy
Growth factor
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs