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

• ClinicalTrials.gov Identifier: NCT00646763
• Recruitment Status: Terminated
• First Posted: March 28, 2008
• Results First Posted: May 11, 2012
• Last Update Posted: December 20, 2013
• Sponsor: Emory University
• Information provided by (Responsible Party): Edmund Waller, Emory University

Tracking Information

• First Submitted Date: March 25, 2008
• First Posted Date: March 28, 2008
• Results First Submitted Date: March 14, 2012
• Results First Posted Date: May 11, 2012
• Last Update Posted Date: December 20, 2013
• Study Start Date: April 2008
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2012)

• The Total Number of CD34+ Cells Collected. [ Time Frame: 4 days ]
• Number of Participants for Whom Target Number of CD34+ Cells Were Collected. [ Time Frame: 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

• Original Primary Outcome Measures (submitted: March 27, 2008): The total number of PBSC collected and the number of days required to collect an adequate number of cells. [ Time Frame: Measurements will be recorded each day of stem cell collection ]

Current Secondary Outcome Measures (submitted: April 13, 2012)

Total Number of Days of Apheresis [ Time Frame: 7 days ]

the number of days of apheresis required to collect target numbers of CD34+ cells.

• Original Secondary Outcome Measures (submitted: March 27, 2008): Adverse events as reported by patient questionnaire, physical assessment and laboratory results. Time to neutrophil and platelet engraftment will be determined by laboratory results. [ Time Frame: Adverse events will be recorded every day of study. Engraftment data will be recorded 30 days post transplant. ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation
• Official Title: 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
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cytokines

Intervention

• 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 Name: Neupogen, Leukine, growth factors
• 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 Name: Neupogen, Leukine, growth factors

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 13, 2012): 35
• Original Estimated Enrollment (submitted: March 27, 2008): 30
• Actual Study Completion Date: February 2011
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00646763
• Other Study ID Numbers: IRB00007445; 7445 ( Other Identifier: Other )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Edmund Waller, Emory University
• Original Responsible Party: Edmund Waller, MD, Winship Cancer Institute
• Current Study Sponsor: Emory University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Emory University
• Verification Date: November 2013