Pegfilgrastim Versus Filgrastim After High-dose Chemotherapy

Armando Santoro, MD

Status and phase: Completed; Phase 2

Conditions: Tumors; Hematological Neoplasms

Treatments: Drug: Filgrastim; Drug: Pegfilgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00410696

ONC-2006-001

EUDRACT 2006-001409-27

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Filgrastim

Active Comparator group

Description:

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

Treatment:

Drug: Filgrastim

Pegfilgrastim

Experimental group

Description:

Pegfilgrastim administered the day after autologous stem-cell reinfusion

Treatment:

Drug: Pegfilgrastim