A Study of 5-Azacitidine (Vidaza®) in Patients With Chronic Myelomonocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01350947
First received: April 29, 2011
Last updated: September 28, 2015
Last verified: September 2015
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Myelomonocytic Leukemia
Intervention: Drug: 5-Azacitidine

  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
No text entered.

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
Arm 1 - 5-Azacitidine

All participants enrolled.

5-Azacitidine: Administered on Days 1-7 of each Cycle.

Subcutaneous administration:

To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.

The 5-azacitidine suspension is administered subcutaneously.

Intravenous Administration:

5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.


Participant Flow:   Overall Study
    Arm 1 - 5-Azacitidine  
STARTED     11  
COMPLETED     11  
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
All Patients

All participants enrolled.

5-Azacitidine: Administered on Days 1-7 of each Cycle.

Subcutaneous administration:

To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.

The 5-azacitidine suspension is administered subcutaneously.

Intravenous Administration:

5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.


Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  11  
Age  
[units: years]
Median (Full Range)
  69   (56 to 85)  
Gender  
[units: participants]
 
Female     5  
Male     6  



  Outcome Measures

1.  Primary:   To Determine the Rate of Complete Hematologic Response (According to IWG 2006 Criteria) in CMML Patients Treated With 5-azacitidine.   [ Time Frame: 24 months ]


  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: Mark Wade
Organization: Huntsman Cancer Institute
phone: 801-213-5746
e-mail: mark.wade@hci.utah.edu


No publications provided


Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01350947     History of Changes
Other Study ID Numbers: HCI47081
Study First Received: April 29, 2011
Results First Received: September 28, 2015
Last Updated: September 28, 2015
Health Authority: United States: Institutional Review Board