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Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuang-Yueh Chiang, Emory University
ClinicalTrials.gov Identifier:
NCT00231309
First received: October 3, 2005
Last updated: August 19, 2014
Last verified: August 2014
Results First Received: August 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hematologic Diseases
Hematologic Malignancies
Intervention: Drug: Granulocyte Colony Stimulating Factor

  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
10 patients were enrolled between July 2003 and March 2006. Patients were enrolled during consent visits for upcoming bone marrow transplants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were not excluded before assignment to groups.

Reporting Groups
  Description
Granulocyte Colony Stimulating Factor Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor

Participant Flow:   Overall Study
    Granulocyte Colony Stimulating Factor  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     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
Single Arm Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor

Baseline Measures
    Single Arm  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     10  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  11.47  ± 4.78  
Gender  
[units: participants]
 
Female     0  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
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1.  Primary:   Numbers of Participants With Disease-free Survival.   [ Time Frame: 260 days ]

2.  Secondary:   Hospital Length of Stay   [ Time Frame: inpatient hospital stay ]


  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
Our study is also limited by its small patient population and short follow-up time.


  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: Kuang-Yueh Chiang, MD
Organization: Emory University
phone: 404-785-1441
e-mail: kuang-yueh.chiang@choa.org


No publications provided


Responsible Party: Kuang-Yueh Chiang, Emory University
ClinicalTrials.gov Identifier: NCT00231309     History of Changes
Other Study ID Numbers: 0561-2003
Study First Received: October 3, 2005
Results First Received: August 14, 2013
Last Updated: August 19, 2014
Health Authority: United States: Institutional Review Board