Pegfilgrastim PBPC Mobilization Study
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Hematology; Oncology
Intervention: pegfilgrastim 12 mg (Drug); filgrastim (Drug); pegfilgrastim 6 mg (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: CD34+ collection during the collection phase
Secondary outcome: Time to ANC and platelet engraftment post-transplant
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant
Locations and Contacts
Additional Information
AmgenTrials clinical trials website Notice regarding posted summaries of trial results To access clinical trial results information click on this link
Starting date: April 2003
Ending date: October 2004
Last updated: February 20, 2008
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