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Pegfilgrastim PBPC Mobilization Study

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ClinicalTrials.gov Identifier: NCT00066092
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : February 28, 2008
Sponsor:
Information provided by:
Amgen

Study Description
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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.
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00066092


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov 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
NHL
mobilization
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs