Pegfilgrastim PBPC Mobilization Study

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00066092
First received: August 4, 2003
Last updated: February 20, 2008
Last verified: February 2008

August 4, 2003
February 20, 2008
April 2003
March 2004   (final data collection date for primary outcome measure)
CD34+ collection during the collection phase [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00066092 on ClinicalTrials.gov Archive Site
Time to ANC and platelet engraftment post-transplant [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Pegfilgrastim PBPC Mobilization Study
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Lymphoma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hematology
  • Oncology
  • Drug: pegfilgrastim 12 mg
    Pegfilgrastim 12 mg given once for PBPC mobilization
    Other Name: Pegfilgrastim 12 mg
  • Drug: filgrastim
    Filgrastim given daily for PBPC mobilization
    Other Name: Filgrastim
  • Drug: pegfilgrastim 6 mg
    Pegfilgrastim 6 mg given once for PBPC mobilization
    Other Name: Pegfilgrastim 6 mg
  • Experimental: Pegfilgrastim 6 mg
    Pegfilgrastim 6 mg given once for PBPC mobilization
    Intervention: Drug: pegfilgrastim 6 mg
  • Experimental: Pegfilgrastim 12 mg
    Pegfilgrastim 12 mg given once for PBPC mobilization
    Intervention: Drug: pegfilgrastim 12 mg
  • Active Comparator: filgrastim
    Filgrastim given daily for PBPC mobilization
    Intervention: Drug: filgrastim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
October 2004
March 2004   (final data collection date for primary outcome measure)
  • Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00066092
20020112
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2008

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