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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cytokines
Interventions Drug: G-CSF, GM-CSF administered at extremities
Drug: G-CSF and GMCSF administered at abdomen
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abdomen Extremities
Hide Arm/Group Description These subjects will have their cytokine injections administered only to their abdomen. The extremity arm will have their injections administered to their upper and/or lower extremities.
Period Title: Overall Study
Started 18 17
Completed 18 17
Not Completed 0 0
Arm/Group Title Abdomen Extremities Total
Hide Arm/Group Description These subjects will have their cytokine injections administered only to their abdomen. The extremity arm will have their injections administered to their upper and/or lower extremities. Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Mean
Number Analyzed 18 participants 17 participants 35 participants
53  (13.76) 52  (17.02) 53  (15.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
10
  55.6%
7
  41.2%
17
  48.6%
Male
8
  44.4%
10
  58.8%
18
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 17 participants 35 participants
18 17 35
Disease type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Lymphoma 4 6 10
Myeloma 14 11 25
1.Primary Outcome
Title The Total Number of CD34+ Cells Collected.
Hide Description [Not Specified]
Time Frame 4 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients at our institution between the ages of 18 and 70 years old with relapsed or refractory Hodgkin's disease, non-Hodgkin's lymphoma, or mutiple myelomawhowere scheduled for an autologous HSCTwere eligible to participate in the study.
Arm/Group Title Abdomen Extremities
Hide Arm/Group Description:
These subjects will have their cytokine injections administered only to their abdomen.
The extremity arm will have their injections administered to their upper and/or lower extremities.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: cells per Kg
9.15*106  (4.7*106) 9.85*106  (4.97*106)
2.Primary Outcome
Title Number of Participants for Whom Target Number of CD34+ Cells Were Collected.
Hide Description 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
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abdomen Extremities
Hide Arm/Group Description:
These subjects will have their cytokine injections administered only to their abdomen.
The extremity arm will have their injections administered to their upper and/or lower extremities.
Overall Number of Participants Analyzed 18 17
Measure Type: Number
Unit of Measure: participants
10 9
3.Secondary Outcome
Title Total Number of Days of Apheresis
Hide Description the number of days of apheresis required to collect target numbers of CD34+ cells.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abdomen Extremities
Hide Arm/Group Description:
These subjects will have their cytokine injections administered only to their abdomen.
The extremity arm will have their injections administered to their upper and/or lower extremities.
Overall Number of Participants Analyzed 18 17
Mean (Standard Deviation)
Unit of Measure: days
2.18  (1.01) 2.00  (0.97)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abdomen Extremities
Hide Arm/Group Description These subjects will have their cytokine injections administered only to their abdomen. The extremity arm will have their injections administered to their upper and/or lower extremities.
All-Cause Mortality
Abdomen Extremities
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Abdomen Extremities
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abdomen Extremities
Affected / at Risk (%) Affected / at Risk (%)
Total   18/18 (100.00%)   17/17 (100.00%) 
Musculoskeletal and connective tissue disorders     
Bone Pain  18/18 (100.00%)  17/17 (100.00%) 
Skin and subcutaneous tissue disorders     
Redness at the injection site  18/18 (100.00%)  17/17 (100.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edmund Waller, MD, PhD
Organization: Emory University Winship Cancer Institute
Phone: 1-888-946-7447
EMail: ewaller@emory.edu
Layout table for additonal information
Responsible Party: Edmund Waller, Emory University
ClinicalTrials.gov Identifier: NCT00646763    
Other Study ID Numbers: IRB00007445
7445 ( Other Identifier: Other )
First Submitted: March 25, 2008
First Posted: March 28, 2008
Results First Submitted: March 14, 2012
Results First Posted: May 11, 2012
Last Update Posted: December 20, 2013