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Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis

This study has been terminated.
(Stopped due to slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630994
First Posted: March 7, 2008
Last Update Posted: December 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
Results First Submitted: January 9, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Other                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 
Overall Participants Analyzed 
[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



Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00630994     History of Changes
Other Study ID Numbers: CDR0000588839
P30CA015083 ( U.S. NIH Grant/Contract )
MC0788 ( Other Identifier: Mayo Clinic Cancer Center )
NCI-2009-01330 ( Registry Identifier: NCI-CTRO )
07-005296 ( Other Identifier: Mayo Clinic IRB )
First Submitted: March 6, 2008
First Posted: March 7, 2008
Results First Submitted: January 9, 2012
Results First Posted: April 2, 2012
Last Update Posted: December 30, 2015