Trial | NCT00410696  Report issue

Title

Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    80
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.
Secondary objective is to evaluate the immunological reconstitution after pegfilgrastim and filgrastim.
Study Started
Sep 30
2006
Primary Completion
Nov 30
2008
Study Completion
Nov 30
2008
Last Update
Jul 01
2013
Estimate

Drug Filgrastim

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

  • Other names: Granulokine

Drug Pegfilgrastim

6 mg/day sc at day +1

  • Other names: Neulasta

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)

Pegfilgrastim Experimental

Pegfilgrastim administered the day after autologous stem-cell reinfusion

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
No Results Posted