A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

Phase 2

Terminated

• Conditions: Cytokines
• Interventions: Drug: G-CSF and GMCSF administered at abdomen; Drug: G-CSF, GM-CSF administered at extremities

• Registration Number: NCT00646763
• Lead Sponsor: Emory University

Brief Summary

The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-03-25
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Study Start: 2008-04
• Primary Completion: 2009-09
• Study Completion: 2011-02
• Results First Submitted: 2012-03-14
• Results First Submitted QC: 2012-04-13
• Results First Posted: 2012-05-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdomen	G-CSF and GMCSF administered at abdomen	These subjects will have their cytokine injections administered only to their abdomen.
Extremities	G-CSF, GM-CSF administered at extremities	The extremity arm will have their injections administered to their upper and/or lower extremities.

Primary Outcome Measures

Name	Time	Method
The Total Number of CD34+ Cells Collected.	4 days
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.	7 days	Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 \* 10\^6 cells/kg, a cell dose that consistently results in rapid cell engraftment

Secondary Outcome Measures

Name	Time	Method
Total Number of Days of Apheresis	7 days	the number of days of apheresis required to collect target numbers of CD34+ cells.

Trial Locations

Locations (1)

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States