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A Comparison of Dendritic Cell Content and T-Cell Phenotype Between Granulocyte Colony-Stimulating Factor (G-CSF) or G-CSF + Granulocyte Macrophage (GM)-CSF

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00208949
First Posted: September 21, 2005
Last Update Posted: September 14, 2012
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.
Information provided by (Responsible Party):
Sagar Lonial, Emory University
Results First Submitted: March 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hematologic Diseases
Interventions: Drug: G-CSF
Drug: GM-CSF

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
G-CSF (Granulocyte Colony- Stimulating Factor) Single use of G-CSF
G-CSF and GM-CSF (Granulocyte Macrophage) Combined use of G-CSF and GM-CSF

Participant Flow:   Overall Study
    G-CSF (Granulocyte Colony- Stimulating Factor)   G-CSF and GM-CSF (Granulocyte Macrophage)
STARTED   25   25 
COMPLETED   25   25 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
G-CSF (Granulocyte Colony- Stimulating Factor) Single use of G-CSF
G-CSF and GM-CSF (Granulocyte Macrophage) Combined use of G-CSF and GM-CSF
Total Total of all reporting groups

Baseline Measures
   G-CSF (Granulocyte Colony- Stimulating Factor)   G-CSF and GM-CSF (Granulocyte Macrophage)   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   23   22   45 
>=65 years   2   3   5 
Age, Customized 
[Units: Years]
Median (Full Range)
 43 
 (22 to 64) 
 53 
 (24 to 69) 
 49 
 (22 to 69) 
Gender 
[Units: Participants]
     
Female   10   14   24 
Male   15   11   26 
Region of Enrollment 
[Units: Participants]
     
United States   25   25   50 


  Outcome Measures
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1.  Primary:   Measure the pDC (Plasmacytoid Dendritic Cells )Content of the Graft   [ Time Frame: at transplant (1 day) ]

2.  Secondary:   Median Survival of Recipients of Grafts Mobilized With GM+G+CSF (Granulocyte Colony-Stimulating Factor (G-CSF)+ Granulocyte Macrophage (GM)-CSF) and G-CSF (Granulocyte Colony-Stimulating Factor )at the Time of Last Follow up.   [ Time Frame: 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Sagar Lonial
Organization: Emory University
phone: 404-778-1900
e-mail: SLONI01@emory.edu



Responsible Party: Sagar Lonial, Emory University
ClinicalTrials.gov Identifier: NCT00208949     History of Changes
Other Study ID Numbers: 0693-2002
First Submitted: September 13, 2005
First Posted: September 21, 2005
Results First Submitted: March 22, 2012
Results First Posted: September 14, 2012
Last Update Posted: September 14, 2012