We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118287
First Posted: July 11, 2005
Last Update Posted: May 24, 2017
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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bart Scott, Fred Hutchinson Cancer Research Center
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
Interventions: Drug: azacitidine
Biological: etanercept

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Chemotherapy, Chemoprotection)

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

etanercept: Given SC


Participant Flow:   Overall Study
    Treatment (Chemotherapy, Chemoprotection)
STARTED   32 
COMPLETED   30 
NOT COMPLETED   2 
Intracranial haemorrhage                1 
Muscle pain                1 



  Baseline Characteristics
  Hide 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
  Description
Treatment (Chemotherapy, Chemoprotection)

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

etanercept: Given SC


Baseline Measures
   Treatment (Chemotherapy, Chemoprotection) 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Median (Full Range)
 69 
 (31 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  34.4% 
Male      21  65.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      31  96.9% 
Unknown or Not Reported      1   3.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   3.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      1   3.1% 
White      30  93.8% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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


Results Point of Contact:  
Name/Title: Bart Scott
Organization: Fred Hutchinson Cancer Research Center
phone: 206-667-1990
e-mail: bscott@fredhutch.org



Responsible Party: Bart Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00118287     History of Changes
Other Study ID Numbers: 1926.00
NCI-2011-01818 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017