Pegfilgrastim PBPC Mobilization Study - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00066092

Purpose

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.

Condition	Intervention	Phase
Lymphoma Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Hematology Oncology	Drug: pegfilgrastim 12 mg Drug: filgrastim Drug: pegfilgrastim 6 mg	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Hodgkin Disease Lymphoma

Drug Information available for: Filgrastim Pegfilgrastim

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	41
Study Start Date:	April 2003
Study Completion Date:	October 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pegfilgrastim 6 mg: Experimental Pegfilgrastim 6 mg given once for PBPC mobilization	Drug: pegfilgrastim 6 mg Pegfilgrastim 6 mg given once for PBPC mobilization
Pegfilgrastim 12 mg: Experimental Pegfilgrastim 12 mg given once for PBPC mobilization	Drug: pegfilgrastim 12 mg Pegfilgrastim 12 mg given once for PBPC mobilization
filgrastim: Active Comparator Filgrastim given daily for PBPC mobilization	Drug: filgrastim Filgrastim given daily for PBPC mobilization

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066092

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020112
Study First Received:	August 4, 2003
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00066092 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

PBPC transplant
Hodgkin's Disease
Non-Hodgkin's Lymphoma
NHL
mobilization

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease

ClinicalTrials.gov processed this record on November 25, 2009