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Azacitidine in Treating Patients With Myelofibrosis

This study has been terminated.
(Due to lack of accrual and trial has demonstrated too little clinical benefit)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00381693
First received: September 26, 2006
Last updated: April 19, 2011
Last verified: April 2011
Results First Received: November 9, 2010  
Study Type: Interventional
Study Design: Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Intervention: Drug: 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
Ten patients were recruited from August 2006 to December 2007 at Mayo Clinic. This trial was permanently closed in December 2007 due to lack of accrual and it demonstrated too little clinical benefit.

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
Azacitidine Azacitidine 75 mg/m^2 subcutaneously

Participant Flow:   Overall Study
    Azacitidine  
STARTED     10  
COMPLETED     2  
NOT COMPLETED     8  
Death                 1  
Adverse Event                 4  
Patient Choice                 1  
Progression                 2  



  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
Azacitidine Azacitidine 75 mg/m^2 subcutaneously

Baseline Measures
    Azacitidine  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Median ( Full Range )
  72  
  ( 57 to 76 )  
Gender  
[units: participants]
 
Female     2  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     10  
Disease  
[units: participants]
 
Primary Myelofibrosis     8  
Post-polycythemia Vera Myelofibrosis     1  
Post-essential Thrombocythemia Myelofibrosis     1  
Lilie Score at Diagnosis (Myelofibrosis only) [1]
[units: participants]
 
0 (Low Risk)     2  
1 (Intermediate Risk)     5  
2 (High Risk)     3  
Red Cell Transfusion-dependent  
[units: participants]
 
Yes     7  
No     3  
Prior Thrombosis or Hemorrhage  
[units: participants]
 
Yes     0  
No     10  
Prior Therapy for Myelofibrosis  
[units: participants]
 
Yes     7  
No     3  
[1] A scoring system reported by Dupriez et al, which was constructed with the two adverse prognostic factors, namely Hb < 10 g/dL and WBC < 4 or > 30 x 10(9)/L, used to separate patients in three groups with low (0 factor), intermediate (1 factor), and high (2 factors) risks, associated with a median survival of 93, 26, and 13 months, respectively.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patients With Confirmed Response (Complete Remission or Partial Remission on 2 Consecutive Evaluation at Least 4 Weeks Apart) During the First 4 Months of Treatment   [ Time Frame: 4 months ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From date of registration until death or 3 years after registration if patient is still alive ]

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

4.  Secondary:   Number of Participants With Treatment Related Adverse Events   [ Time Frame: Every 4 weeks during treatment ]


  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: Dr. Ruben A. Mesa
Organization: Mayo Clinic
phone: 507-284-3533 ext 4-3533
e-mail: mesa.ruben@mayo.edu


No publications provided


Responsible Party: Ruben A. Mesa, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00381693     History of Changes
Other Study ID Numbers: CDR0000503972, P30CA015083, MC058D, 05-004297
Study First Received: September 26, 2006
Results First Received: November 9, 2010
Last Updated: April 19, 2011
Health Authority: United States: Food and Drug Administration