Tissue Repair in Stem Cell Transplant Recipients

This study has been terminated.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00501228
First received: July 12, 2007
Last updated: July 31, 2012
Last verified: July 2012
Results First Received: March 3, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Graft-Versus-Host Disease
Intervention: Drug: Filgrastim

  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
Recruitment Period: 06/15/2005 through 05/03/2006. All participants enrolled at U.T. M.D. Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study terminated early due to lack of accrual.

Reporting Groups
  Description
Filgrastim Injections No text entered.

Participant Flow:   Overall Study
    Filgrastim Injections  
STARTED     2  
COMPLETED     1  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  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
Filgrastim Injections No text entered.

Baseline Measures
    Filgrastim Injections  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Median ( Full Range )
  48  
  ( 40 to 56 )  
Gender  
[units: Participants]
 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures

1.  Primary:   Number of Donor Derived Cells After G-CSF Therapy   [ Time Frame: Baseline + 8 Weeks post transplant ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
Study was closed because of the very limited number of patients enrolled. Patients eligible for enrollment were not willing to undergo 4 weekly cycles of G-CSF treatment because of the well known side effect of bone pain.  


Results Point of Contact:  
Name/Title: Martin Korbling, MD / Professor
Organization: U.T. M.D. Anderson Cancer Center
phone: 713-745-3219


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00501228     History of Changes
Other Study ID Numbers: ID02-300
Study First Received: July 12, 2007
Results First Received: March 3, 2009
Last Updated: July 31, 2012
Health Authority: United States: Institutional Review Board