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

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.

Study Overview

• Status: Terminated
• Conditions: Cytokines
• Intervention / Treatment: Drug: G-CSF and GMCSF administered at abdomen; Drug: G-CSF, GM-CSF administered at extremities

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Abdomen; These subjects will have their cytokine injections administered only to their abdomen.	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.; Other Names: Neupogen, Leukine, growth factors
Active Comparator: Extremities; The extremity arm will have their injections administered to their upper and/or lower extremities.	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.; Other Names: Neupogen, Leukine, growth factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Total Number of CD34+ Cells Collected.		4 days
Number of Participants for Whom Target Number of CD34+ Cells Were Collected.	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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Days of Apheresis	the number of days of apheresis required to collect target numbers of CD34+ cells.	7 days

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Edmund Waller, MD, Emory University Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 27, 2008
• First Posted (Estimated): March 28, 2008

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Adjuvants, Immunologic; Lenograstim; Sargramostim; Mitogens
• Other Study ID Numbers: IRB00007445; 7445 (Other)