NCT00410696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

July 1, 2013

Status Verified

June 1, 2013

Enrollment Period

2.2 years

First QC Date

December 12, 2006

Last Update Submit

June 28, 2013

Conditions

Hematological NeoplasmsTumors

Keywords

High-dose chemotherapyGrowth factorPegfilgrastim

Outcome Measures

Primary Outcomes (1)

  • Duration of aplasia period

    At time of discharge from Unit

Secondary Outcomes (1)

  • Immunological reconstitution

    1 year after transplantation

Study Arms (2)

Filgrastim

ACTIVE COMPARATOR

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

Pegfilgrastim

EXPERIMENTAL

Pegfilgrastim administered the day after autologous stem-cell reinfusion

Drug: Pegfilgrastim

Interventions

FilgrastimDRUG

5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution

Also known as: Granulokine
Filgrastim
PegfilgrastimDRUG

6 mg/day sc at day +1

Also known as: Neulasta
Pegfilgrastim

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Use of other experimental drugs
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Related Publications (3)

  • Holmes FA, O'Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb 1;20(3):727-31. doi: 10.1200/JCO.2002.20.3.727.

    PMID: 11821454BACKGROUND

  • Farese AM, Yang BB, Roskos L, Stead RB, MacVittie TJ. Pegfilgrastim, a sustained-duration form of filgrastim, significantly improves neutrophil recovery after autologous marrow transplantation in rhesus macaques. Bone Marrow Transplant. 2003 Aug;32(4):399-404. doi: 10.1038/sj.bmt.1704156.

    PMID: 12900776BACKGROUND

  • Castagna L, Bramanti S, Levis A, Michieli MG, Anastasia A, Mazza R, Giordano L, Sarina B, Todisco E, Gregorini AI, Santoro A. Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Ann Oncol. 2010 Jul;21(7):1482-1485. doi: 10.1093/annonc/mdp576. Epub 2009 Dec 11.

    PMID: 20007996DERIVED

MeSH Terms

Conditions

Hematologic NeoplasmsNeoplasms

Interventions

Filgrastimpegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by SiteHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Armando Santoro, MD

    Istituto Clinico Humanitas

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

September 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

July 1, 2013

Record last verified: 2013-06

Locations

IT(1)