Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00113321
First received: June 7, 2005
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: September 25, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Intervention: Drug: Decitabine

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

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


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00113321     History of Changes
Other Study ID Numbers: 2004-0468
Study First Received: June 7, 2005
Results First Received: September 25, 2009
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration