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Pegfilgrastim Same-Day vs Next-Day in NHL

NCT00115193Phase 2

Key facts

Status: Completed
Start: Feb 2003
Primary completion: Aug 2005
Sponsor: Amgen
Modality: Recombinant Proteins and Enzymes

Drugs: pegfilgrastim
Conditions: chemotherapy-induced neutropenia (CIN)

Overview

Phase 2, randomised, double-blind trial of pegfilgrastim in chemotherapy-induced neutropenia (CIN) (2 arms), sponsored by Amgen. Primary endpoints: Duration of grade 4 neutropenia and Incidence of febrile neutropenia. Started Feb 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Same Day Pegfilgrastim
Pegfilgrastim 6 mg on day 1 of each cycle (within 4 hours of chemotherapy completion)
Next Day Pegfilgrastim
Pegfilgrastim 6 mg on day 2 of each cycle (at least 24 hours after chemotherapy completion)

Who it enrols

Previously untreated patients with histologically proven mantle cell lymphoma or diffuse large B-cell non-Hodgkin's lymphoma.

Endpoints

Primary

Duration of grade 4 neutropeniaEnd of study
Incidence of febrile neutropeniaEnd of study

Secondary

Incidence of hematologic toxicitiesEnd of study
Incidence of non-hematologic toxicitiesEnd of study
Number of subjects who received planned doses of chemotherapy on timeEnd of study
Response ratesEnd of study

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