Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Phase 2

Completed

• Conditions: Hematological Neoplasms; Tumors
• Interventions: Drug: Pegfilgrastim; Drug: Filgrastim

• Registration Number: NCT00410696
• Lead Sponsor: Armando Santoro, MD

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.

Detailed Description

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

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-28
• Last Update Posted: 2013-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim	Pegfilgrastim	Pegfilgrastim administered the day after autologous stem-cell reinfusion
Filgrastim	Filgrastim	Filgrastim administration starting 1 day after autologous stem-cell reinfusion up to hemopoietic reconstitution (defined as more than 500/mm3 for 2 days)

Primary Outcome Measures

Name	Time	Method
Duration of aplasia period	At time of discharge from Unit

Secondary Outcome Measures

Name	Time	Method
Immunological reconstitution	1 year after transplantation

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy