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Decitabine (DAC) w/ or w/o Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00414310
First received: December 19, 2006
Last updated: July 15, 2015
Last verified: July 2015
Results First Received: July 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Acute Myelogenous Leukemia
Interventions: Drug: Decitabine
Drug: Valproic Acid

  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: 12/13/2006 to 07/05/2010. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 153 participants registered on the study for Decitabine (DAC) with or without Valproic Acid (VPA) in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML), three were screen failures therefore 150 patients were randomized with 149 participants treated.

Reporting Groups
  Description
Decitabine Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
Decitabine + Valproic Acid Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.

Participant Flow:   Overall Study
    Decitabine   Decitabine + Valproic Acid
STARTED   71   79 
COMPLETED   70   79 
NOT COMPLETED   1   0 
Not treated                1                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 Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
Decitabine + Valproic Acid Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
Total Total of all reporting groups

Baseline Measures
   Decitabine   Decitabine + Valproic Acid   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   79   150 
Age 
[Units: Years]
Median (Full Range)
 71 
 (39 to 85) 
 66 
 (20 to 90) 
 69 
 (20 to 90) 
Gender 
[Units: Participants]
     
Female   21   37   58 
Male   50   42   92 
Region of Enrollment 
[Units: Participants]
     
United States   71   79   150 


  Outcome Measures

1.  Primary:   Participant Response Rates to Decitabine With or Without Valproic Acid in MDS and AML   [ Time Frame: 1 Year ]

2.  Secondary:   Participant Response Durations/Length of Survival   [ Time Frame: 1 Year or to disease progression ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
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  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, MD/Chair, Leukemia Department
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7026
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00414310     History of Changes
Other Study ID Numbers: 2006-0686
NCI-2012-01396 ( Registry Identifier: NCI CTRP )
Study First Received: December 19, 2006
Results First Received: July 15, 2015
Last Updated: July 15, 2015
Health Authority: United States: Food and Drug Administration