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Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure

This study has been terminated.
(Low Accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00113321
First Posted: June 8, 2005
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:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Intervention: Drug: Decitabine

  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 3/28/05 - 11/7/08; all patients were registered at The University of Texas 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 was terminated due to low accrual.

Reporting Groups
  Description
Decitabine 20 mg/m2 by vein (IV) over 1 hour daily x 5 days.

Participant Flow:   Overall Study
    Decitabine
STARTED   16 
COMPLETED   16 
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
Decitabine 20 mg/m2 by vein (IV) over 1 hour daily x 5 days.

Baseline Measures
   Decitabine 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   15 
Age 
[Units: Years]
Median (Full Range)
 75 
 (58 to 85) 
Gender 
[Units: Participants]
 
Female   2 
Male   14 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures

1.  Primary:   Overall Response   [ Time Frame: Blood tests baseline and after completing 8-12 weeks of therapy ]


  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
No text entered.


  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: Hagop Kantarjian, M.D., Professor
Organization: The University of Texas M. D. Anderson Cancer Center
phone: 713/792-7026
e-mail: eharriso@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113321     History of Changes
Other Study ID Numbers: 2004-0468
First Submitted: June 7, 2005
First Posted: June 8, 2005
Results First Submitted: September 25, 2009
Results First Posted: February 21, 2011
Last Update Posted: August 7, 2012



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