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Pegfilgrastim PBPC Mobilization Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066092
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : February 28, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Lymphoma Hodgkin's Lymphoma Non-Hodgkin's Lymphoma Hematology Oncology Drug: pegfilgrastim 12 mg Drug: filgrastim Drug: pegfilgrastim 6 mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : April 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : October 2004

Arm Intervention/treatment
Experimental: Pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for PBPC mobilization
Drug: pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for PBPC mobilization

Experimental: Pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for PBPC mobilization
Drug: pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for PBPC mobilization

Active Comparator: filgrastim
Filgrastim given daily for PBPC mobilization
Drug: filgrastim
Filgrastim given daily for PBPC mobilization

Primary Outcome Measures :
  1. CD34+ collection during the collection phase [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Time to ANC and platelet engraftment post-transplant [ Time Frame: 100 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066092

Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00066092    
Obsolete Identifiers: NCT00060229
Other Study ID Numbers: 20020112
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: February 28, 2008
Last Verified: February 2008
Keywords provided by Amgen:
PBPC transplant
Hodgkin's Disease
Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs