Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS)

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00569010
First received: December 5, 2007
Last updated: July 26, 2012
Last verified: July 2012
Results First Received: January 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Leukemia
Interventions: Drug: Azacitidine
Drug: Ara-C

  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 12/28/2005 to 8/25/2008. All participants 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
Of the 36 enrolled, only 34 evaluable participants were included in this study and started study drug.

Reporting Groups
  Description
Low-Dose Ara-C + AZA-Level 0 Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
Low-Dose Ara-C + AZA-Level 1 Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
High-Dose Ara-C + AZA-Level 0 Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
High-Dose Ara-C + AZA-Level 1 High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days

Participant Flow:   Overall Study
    Low-Dose Ara-C + AZA-Level 0     Low-Dose Ara-C + AZA-Level 1     High-Dose Ara-C + AZA-Level 0     High-Dose Ara-C + AZA-Level 1  
STARTED     6     6     11     11  
COMPLETED     6     6     11     11  
NOT COMPLETED     0     0     0     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
Low-Dose Ara-C + AZA-Level 0 Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
Low-Dose Ara-C + AZA-Level 1 Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
High-Dose Ara-C + AZA-Level 0 Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
High-Dose Ara-C + AZA-Level 1 High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
Total Total of all reporting groups

Baseline Measures
    Low-Dose Ara-C + AZA-Level 0     Low-Dose Ara-C + AZA-Level 1     High-Dose Ara-C + AZA-Level 0     High-Dose Ara-C + AZA-Level 1     Total  
Number of Participants  
[units: participants]
  6     6     11     11     34  
Age  
[units: years]
Mean ( Full Range )
  44  
  ( 31 to 76 )  
  61  
  ( 49 to 75 )  
  74  
  ( 52 to 79 )  
  62  
  ( 38 to 69 )  
  61  
  ( 31 to 79 )  
Gender  
[units: participants]
         
Female     3     4     3     5     15  
Male     3     2     8     6     19  
Region of Enrollment  
[units: participants]
         
United States     6     6     11     11     34  



  Outcome Measures

1.  Primary:   Number of Participants With Complete Remission   [ Time Frame: 6 weeks ]


  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: Jean-Pierre Issa, M.D./Professor
Organization: The University of MD Anderson Cancer Center
phone: 713-745-2260
e-mail: eharriso@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00569010     History of Changes
Other Study ID Numbers: 2005-0291
Study First Received: December 5, 2007
Results First Received: January 21, 2011
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board