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Etanercept (Enbrel) for Juvenile Myelomonocytic Leukemia

This study has been terminated.
(Slow enrollment; study terminated.)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00509600
First received: July 27, 2007
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: August 31, 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: 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  
Number of Participants  
[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


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00509600     History of Changes
Other Study ID Numbers: 2004-0215
Study First Received: July 27, 2007
Results First Received: August 31, 2009
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board