A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation
NCT ID: NCT00646763
Last Updated: 2025-04-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2008-04-30
2011-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abdomen
These subjects will have their cytokine injections administered only to their abdomen.
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.
Extremities
The extremity arm will have their injections administered to their upper and/or lower extremities.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Emory University
OTHER
Responsible Party
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Edmund Waller
Principal Investigator
Principal Investigators
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Edmund Waller, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Winship Cancer Institute
Locations
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Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Other Identifiers
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7445
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00007445
Identifier Type: -
Identifier Source: org_study_id
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