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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Cytokines

Thank you

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 InstituteAtlanta, Georgia  30322