Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis

This study has been terminated.
(Stopped due to slow accrual)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00630994
First received: March 6, 2008
Last updated: November 9, 2012
Last verified: November 2012
Results First Received: January 9, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Intervention: Drug: Dacogen

  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
Four (4) patient was recruited from March 2008 to May 2009 at Mayo Clinic. This trial was permanently closed in September 2009 due to slow accrual.

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
Decitabine 20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle

Participant Flow:   Overall Study
    Decitabine  
STARTED     4  
COMPLETED     0  
NOT COMPLETED     4  
Adverse Event                 1  
Disease Progression                 1  
Lack of Efficacy                 1  
Unknown                 1  



  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 20 mg/m^2/day intravenous over one hour on days 1-5 out of 28 days of treatment cycle

Baseline Measures
    Decitabine  
Number of Participants  
[units: participants]
  4  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 6.6  
Gender  
[units: participants]
 
Female     1  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     4  
Prior disease specific therapy (including drugs, stem cell transplant, or splenectomy)  
[units: participants]
 
Yes     2  
No     2  
Prior bleeding events felt to be related to underlying disease  
[units: participants]
 
Yes     0  
No     4  
Prior thrombosis  
[units: participants]
 
Yes     2  
No     2  
Category of Primary myelofibrosis  
[units: participants]
 
Primary Myelofibrosis     2  
Post Essential Thrombocythemia (ET) Myelofibrosis     1  
Post Polycythemia Vera (PV) Myelofibrosis     1  



  Outcome Measures
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1.  Primary:   Number of Participants Who Achieve a Confirmed Response (Complete Remission (CR), Partial Remission (PR), or Clinical Improvement (CI)), According to International Working Group (IWG) Consensus Criteria.   [ Time Frame: Every 4 weeks during treatment (up to 16 weeks) ]

2.  Secondary:   Overall Survival(OS)   [ Time Frame: up to 3 years ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: up to 3 years ]

4.  Secondary:   Number of Participants With Constitutional Symptoms   [ Time Frame: Up to 48 weeks ]

5.  Secondary:   Number of Participants With Severe Adverse Events   [ Time Frame: Up to 48 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
Study terminated early. Most analyses were not performed.


  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: Dr. Ruben A. Mesa
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: mesa.ruben@mayo.edu


No publications provided


Responsible Party: Ruben A. Mesa, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00630994     History of Changes
Other Study ID Numbers: CDR0000588839, P30CA015083, MC0788, NCI-2009-01330, 07-005296
Study First Received: March 6, 2008
Results First Received: January 9, 2012
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration