NCT00646763

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytokines

Interventions

Type	Name	Description
DRUG	G-CSF, GM-CSF administered at extremities	Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.
DRUG	G-CSF and GMCSF administered at abdomen	Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-09-01
• Completion: 2011-02-01
• First posted: 2008-03-28
• Last updated: 2025-04-01
• Results posted: 2012-05-11

Locations

1 site across 1 country: United States