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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Hematology, Oncology

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Trial Information

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 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.

Inclusion Criteria


- Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC
transplant - No previous bone marrow or PBPC transplant

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

CD34+ collection during the collection phase

Outcome Time Frame:

10 days

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20020112

NCT ID:

NCT00066092

Start Date:

April 2003

Completion Date:

October 2004

Related Keywords:

  • Lymphoma
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma
  • Hematology
  • Oncology
  • PBPC transplant
  • Hodgkin's Disease
  • Non-Hodgkin's Lymphoma
  • NHL
  • mobilization
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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