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Pegfilgrastim PBPC Mobilization Study

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00066092
Collaborator
(none)
41
Enrollment
3
Arms
18
Duration (Months)

Study Details

Study Description

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
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

Study Type:
Interventional
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 :
Apr 1, 2003
Actual Primary Completion Date :
Mar 1, 2004
Actual Study Completion Date :
Oct 1, 2004

Arms and Interventions

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

Primary Outcome Measures

  1. CD34+ collection during the collection phase [10 days]

Secondary Outcome Measures

  1. Time to ANC and platelet engraftment post-transplant [100 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Amgen

Investigators

  • Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00066092
Other Study ID Numbers:
  • 20020112
  • NCT00060229
First Posted:
Aug 5, 2003
Last Update Posted:
Feb 28, 2008
Last Verified:
Feb 1, 2008
Keywords provided by , ,
PBPC transplant
Hodgkin's Disease
Non-Hodgkin's Lymphoma
NHL
mobilization
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lenograstim

Study Results

No Results Posted as of Feb 28, 2008