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Azacitidine in Treating Patients With Myelofibrosis

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.
ClinicalTrials.gov Identifier: NCT00381693
Recruitment Status : Terminated (Due to lack of accrual and trial has demonstrated too little clinical benefit)
First Posted : September 28, 2006
Results First Posted : January 24, 2011
Last Update Posted : April 21, 2011
Sponsor:
Collaborator:
Information provided by:

Study Type: Interventional
Study Design: Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Myeloproliferative Disorders
Secondary Myelofibrosis
Intervention: Drug: azacitidine

  Participant Flow

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

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 
Overall Participants Analyzed 
[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 
[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.
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 


  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

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

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



Responsible Party: Ruben A. Mesa, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00381693     History of Changes
Other Study ID Numbers: CDR0000503972
P30CA015083 ( U.S. NIH Grant/Contract )
MC058D ( Other Identifier: Mayo Clinic Cancer Center )
05-004297 ( Other Identifier: Mayo Clinic IRB )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: November 9, 2010
Results First Posted: January 24, 2011
Last Update Posted: April 21, 2011