A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
18 Years
N/A
Both
Cytokines
Trial Information
A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant
The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF,
which are cytokines, or growth factors. The doctor may also choose to use these growth
factors in combination with chemotherapy to increase the number of stem cells in the blood.
Both options are established and are effective in increasing the number of stem cells in the
blood.
Patients will receive one shot under the skin twice a day for approximately 12-15 days after
receiving chemotherapy through the time your cells are being collected. Patients will be
randomly assigned to receive growth factors administered either to their abdomen or to their
extremities. Both shots will always be given either in the abdomen or in the extremities.
Inclusion Criteria:
- All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for
relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with
myeloma. All patients must meet criteria for transplantation.
Exclusion Criteria:
- Patients with active, invasive/systemic fungal infection.
- Patients who are pregnant or lactating females.
- Patients with active CNS malignant disease or life expectancy limited by diseases
other than the disease for which the patient is being transplanted.
- Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The Total Number of CD34+ Cells Collected.
Outcome Time Frame:
4 days
Safety Issue:
No
Principal Investigator
Edmund Waller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Emory University Winship Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
7445
NCT ID:
NCT00646763
Start Date:
April 2008
Completion Date:
February 2011
Related Keywords:
- Cytokines
Name | Location |
|---|---|
| Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |
