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Clinical Trials/NCT00066092
NCT00066092
Completed
Phase 2

Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma.

Amgen0 sites41 target enrollmentApril 2003

Overview

Phase
Phase 2
Intervention
pegfilgrastim 6 mg
Conditions
Lymphoma
Sponsor
Amgen
Enrollment
41
Primary Endpoint
CD34+ collection during the collection phase
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
October 2004
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Amgen

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Pegfilgrastim 6 mg

Pegfilgrastim 6 mg given once for PBPC mobilization

Intervention: pegfilgrastim 6 mg

Pegfilgrastim 12 mg

Pegfilgrastim 12 mg given once for PBPC mobilization

Intervention: pegfilgrastim 12 mg

filgrastim

Filgrastim given daily for PBPC mobilization

Intervention: filgrastim

Outcomes

Primary Outcomes

CD34+ collection during the collection phase

Time Frame: 10 days

Secondary Outcomes

  • Time to ANC and platelet engraftment post-transplant(100 days)

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