Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Armando Santoro, MD80 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematological Neoplasms Tumors

Interventions

FilgrastimDRUG

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

PegfilgrastimDRUG

6 mg/day sc at day +1

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Outcomes

Primary Outcomes

Duration of aplasia period

Time frame: At time of discharge from Unit

Secondary Outcomes

Immunological reconstitution

Time frame: 1 year after transplantation

Data from ClinicalTrials.gov

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