Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
NCT ID: NCT00410696
Last Updated: 2013-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2006-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Filgrastim
Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)
Filgrastim
5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
Pegfilgrastim
Pegfilgrastim administered the day after autologous stem-cell reinfusion
Pegfilgrastim
6 mg/day sc at day +1
Interventions
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Filgrastim
5 mcg/kg/day sc from day +1 after transplantation to hemopoietic reconstitution
Pegfilgrastim
6 mg/day sc at day +1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate organ function
* Written informed consent.
Exclusion Criteria
* Active infection
18 Years
ALL
No
Sponsors
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Armando Santoro, MD
OTHER
Responsible Party
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Armando Santoro, MD
MD
Principal Investigators
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Armando Santoro, MD
Role: STUDY_DIRECTOR
Istituto Clinico Humanitas
Locations
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Istituto Clinico Humanitas
Rozzano, Milan, Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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EUDRACT 2006-001409-27
Identifier Type: -
Identifier Source: secondary_id
ONC-2006-001
Identifier Type: -
Identifier Source: org_study_id
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