Pegfilgrastim PBPC Mobilization Study

Phase 2

Completed

• Conditions: Lymphoma; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Hematology; Oncology
• Interventions: Drug: pegfilgrastim 12 mg; Drug: pegfilgrastim 6 mg; Drug: filgrastim

• Registration Number: NCT00066092
• Lead Sponsor: Amgen

Brief Summary

This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.

Detailed Description

This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified version of Filgrastim that is longer acting.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-08-04
• Study First Submitted QC: 2003-08-04
• Study First Posted: 2003-08-05
• Primary Completion: 2004-03
• Study Completion: 2004-10
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-20
• Last Update Posted: 2008-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pegfilgrastim 12 mg	pegfilgrastim 12 mg	Pegfilgrastim 12 mg given once for PBPC mobilization
Pegfilgrastim 6 mg	pegfilgrastim 6 mg	Pegfilgrastim 6 mg given once for PBPC mobilization
filgrastim	filgrastim	Filgrastim given daily for PBPC mobilization

Primary Outcome Measures

Name	Time	Method
CD34+ collection during the collection phase	10 days

Secondary Outcome Measures

Name	Time	Method
Time to ANC and platelet engraftment post-transplant	100 days