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Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

This study has been terminated.
(Slow enrollment; study terminated.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00509600
First Posted: July 31, 2007
Last Update Posted: August 7, 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.
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: August 31, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Intervention: Drug: Etanercept

  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: 05/19/04 through 03/05/09. All participants recruited at UT MD Anderson Cancer Center.

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

Reporting Groups
  Description
Etanercept 0.8 mg/kg subcutaneously weekly for 90 days

Participant Flow:   Overall Study
    Etanercept
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Adverse Event                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
Etanercept 0.8 mg/kg subcutaneously weekly for 90 days

Baseline Measures
   Etanercept 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Years]
Mean (Full Range)
 3 
 (3 to 3) 
Gender 
[Units: Participants]
 
Female   0 
Male   1 
Region of Enrollment 
[Units: Participants]
 
United States   1 


  Outcome Measures

1.  Primary:   Patient Response   [ Time Frame: 12 weeks ]


  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
Early termination due to low accrual. Rare disease with less than 100 cases diagnosed per year.


  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: Robert J. Wells, MD / Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-6620



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00509600     History of Changes
Other Study ID Numbers: 2004-0215
First Submitted: July 27, 2007
First Posted: July 31, 2007
Results First Submitted: August 31, 2009
Results First Posted: December 2, 2010
Last Update Posted: August 7, 2012



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