Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure

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. Identifier: NCT00113321
Recruitment Status : Terminated (Low Accrual)
First Posted : June 8, 2005
Results First Posted : February 21, 2011
Last Update Posted : August 7, 2012
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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

Participant Flow:   Overall Study

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   1 
>=65 years   15 
[Units: Years]
Median (Full Range)
 (58 to 85) 
[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

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

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

Responsible Party: M.D. Anderson Cancer Center 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