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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00646763
Recruitment Status : Terminated (Accrual goal met)
First Posted : March 28, 2008
Results First Posted : May 11, 2012
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
Edmund Waller, Emory University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cytokines Drug: G-CSF, GM-CSF administered at extremities Drug: G-CSF and GMCSF administered at abdomen Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : February 2011
Arms and Interventions
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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 Name: 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 Name: Neupogen, Leukine, growth factors


Outcome Measures
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Primary Outcome Measures :
  1. The Total Number of CD34+ Cells Collected. [ Time Frame: 4 days ]
  2. 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


Secondary Outcome Measures :
  1. Total Number of Days of Apheresis [ Time Frame: 7 days ]
    the number of days of apheresis required to collect target numbers of CD34+ cells.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646763


Locations
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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Edmund Waller, MD Emory University Winship Cancer Institute
More Information
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Responsible Party: Edmund Waller, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00646763    
Other Study ID Numbers: IRB00007445
7445 ( Other Identifier: Other )
First Posted: March 28, 2008    Key Record Dates
Results First Posted: May 11, 2012
Last Update Posted: December 20, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Lenograstim
Sargramostim
Mitogens
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action