Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Lymphoma
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Hematology
Oncology
Drug: pegfilgrastim 12 mg
Drug: filgrastim
Drug: pegfilgrastim 6 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • CD34+ collection during the collection phase [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to ANC and platelet engraftment post-transplant [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: April 2003
Study Completion Date: October 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for PBPC mobilization
Drug: pegfilgrastim 6 mg
Pegfilgrastim 6 mg given once for PBPC mobilization
Other Name: Pegfilgrastim 6 mg
Experimental: Pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for PBPC mobilization
Drug: pegfilgrastim 12 mg
Pegfilgrastim 12 mg given once for PBPC mobilization
Other Name: Pegfilgrastim 12 mg
Active Comparator: filgrastim
Filgrastim given daily for PBPC mobilization
Drug: filgrastim
Filgrastim given daily for PBPC mobilization
Other Name: Filgrastim

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066092

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00066092     History of Changes
Obsolete Identifiers: NCT00060229
Other Study ID Numbers: 20020112
Study First Received: August 4, 2003
Last Updated: February 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
PBPC transplant
Hodgkin's Disease
Non-Hodgkin's Lymphoma
NHL
mobilization

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014