Skip to main content
OpenTrials
Completed

NCT Number: NCT00410696

Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematological Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Filgrastim

Drug

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

Other names: Granulokine

pegfilgrastim

Drug

6 mg/day sc at day +1

Other names: Neulasta

Primary outcomes

  1. Duration of aplasia period

    Time frame: At time of discharge from Unit

Secondary outcomes

  1. Immunological reconstitution

    Time frame: 1 year after transplantation

Sponsors and collaborators

Lead sponsor

Armando Santoro, MD

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 13, 2006
Registry last updated
Jul 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.