Phase II 5-Azacytidine Plus VPA Plus ATRA

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00326170
First received: May 12, 2006
Last updated: June 12, 2012
Last verified: June 2012
Results First Received: June 6, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Myelodysplastic Syndrome
Acute Myelogenous Leukemia
Interventions: Drug: 5-Azacytidine (5-aza)
Drug: Valproic Acid
Drug: All-Trans Retinoic Acid (ATRA)

  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: 06/10/05 through 11/17/06. All participants recruited at UT MD Anderson Cancer Center.

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
VPA + 5-aza + ATRA Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.

Participant Flow:   Overall Study
    VPA + 5-aza + ATRA  
STARTED     34  
COMPLETED     34  
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
VPA + 5-aza + ATRA Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.

Baseline Measures
    VPA + 5-aza + ATRA  
Number of Participants  
[units: participants]
  34  
Age  
[units: years]
Median ( Full Range )
  70  
  ( 49 to 84 )  
Gender  
[units: participants]
 
Female     11  
Male     23  
Region of Enrollment  
[units: participants]
 
United States     34  



  Outcome Measures

1.  Primary:   Number of Participants With Response   [ Time Frame: Up to 12 cycles of treatment (28 day cycles) ]


  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: Guillermo Garcia-Manero, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-7305
e-mail: eharriso@mdanderson.org


No publications provided by M.D. Anderson Cancer Center

Publications automatically indexed to this study:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00326170     History of Changes
Other Study ID Numbers: 2004-0799
Study First Received: May 12, 2006
Results First Received: June 6, 2011
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration