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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00410696

Enrollment

Registered

2006-12-13

Start date

2006-09-30

Completion date

2008-11-30

Last updated

2013-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Neoplasms, Tumors

Keywords

High-dose chemotherapy, Growth factor, Pegfilgrastim

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.

Interventions

DRUGFilgrastim

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

DRUGPegfilgrastim

6 mg/day sc at day +1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Duration of aplasia period	At time of discharge from Unit

Secondary

Measure	Time frame
Immunological reconstitution	1 year after transplantation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026