Tissue Repair in Stem Cell Transplant Recipients

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. Identifier: NCT00501228
Recruitment Status : Terminated
First Posted : July 16, 2007
Results First Posted : November 20, 2009
Last Update Posted : August 7, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Graft-Versus-Host Disease
Intervention: Drug: Filgrastim

  Participant Flow

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
Filgrastim Injections No text entered.

Participant Flow:   Overall Study
    Filgrastim Injections
Withdrawal by Subject                1 

  Baseline Characteristics

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
Filgrastim Injections No text entered.

Baseline Measures
   Filgrastim Injections 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (40 to 56) 
[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

  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.

  More Information

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

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

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00501228     History of Changes
Other Study ID Numbers: ID02-300
First Submitted: July 12, 2007
First Posted: July 16, 2007
Results First Submitted: March 3, 2009
Results First Posted: November 20, 2009
Last Update Posted: August 7, 2012