Pegfilgrastim PBPC Mobilization Study - Tabular View

Tracking Information

First Received Date ^ICMJE

August 4, 2003

Last Updated Date

February 20, 2008

Start Date ^ICMJE

April 2003

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CD34+ collection during the collection phase [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

*CD34+ collection during the collection phase

Change History

Complete list of historical versions of study NCT00066092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to ANC and platelet engraftment post-transplant [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

*Time to ANC and platelet engraftment post-transplant

Descriptive Information

Brief Title ^ICMJE

Pegfilgrastim PBPC Mobilization Study

Official Title ^ICMJE

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lymphoma
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Hematology
Oncology

Intervention ^ICMJE

Drug: pegfilgrastim 12 mg
Drug: filgrastim
Drug: pegfilgrastim 6 mg

Study Arms / Comparison Groups

Experimental: Pegfilgrastim 6 mg given once for PBPC mobilization
Experimental: Pegfilgrastim 12 mg given once for PBPC mobilization
Active Comparator: Filgrastim given daily for PBPC mobilization

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00066092

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20020112

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP