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Mycophenolate Mofetil (MMF) for Treatment of Chronic Graft-versus-host Disease (GVHD)

This study has been terminated.
(Low probability of positive outcome)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Martin, Paul, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00089141
First received: August 4, 2004
Last updated: May 1, 2013
Last verified: August 2009
History of Changes
Results First Received: July 15, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cancer
Interventions: Drug: mycophenolate mofetil
Drug: placebo

  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
Clinic patients were recruited from May 2004 through June 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mycophenolate Mofetil Patients receive oral mycophenolate mofetil 1000 mg twice daily.
Placebo Patients receive oral placebo twice daily

Participant Flow:   Overall Study
    Mycophenolate Mofetil     Placebo  
STARTED     74     77  
COMPLETED     56     53  
NOT COMPLETED     18     24  
Termination of trial                 18                 24  



  Baseline Characteristics
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Reporting Groups
  Description
Mycophenolate Mofetil Patients receive oral mycophenolate mofetil 1000 mg twice daily.
Placebo Patients receive oral placebo twice daily
Total Total of all reporting groups

Baseline Measures
    Mycophenolate Mofetil     Placebo     Total  
Number of Participants  
[units: participants]
 		  74     77     151  
Age  
[units: participants]
 		     
<=18 years     1     1     2  
Between 18 and 65 years     68     71     139  
>=65 years     5     5     10  
Age  
[units: years]
Mean ± Standard Deviation 		  48.3  ± 13.3     47.9  ± 13.3     48.1  ± 13.3  
Gender  
[units: participants]
 		     
Female     33     37     70  
Male     41     40     81  
Region of Enrollment  
[units: participants]
 		     
United States     73     75     148  
Canada     1     2     3  



  Outcome Measures
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1.  Primary:   Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy   [ Time Frame: 2 years ]
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2.  Secondary:   Definitive Absence of Efficacy Success   [ Time Frame: 2 years ]
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3.  Secondary:   Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy   [ Time Frame: 2 years ]
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4.  Secondary:   Bronchiolitis Obliterans   [ Time Frame: within 4 years ]
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5.  Secondary:   Recurrent Malignancy   [ Time Frame: within 4 years ]
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Measure Type Secondary
Measure Title Recurrent Malignancy
Measure Description Development of recurrent malignancy after enrollment in the study
Time Frame within 4 years  
Safety Issue Yes  

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.
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Reporting Groups
  Description
Mycophenolate Mofetil Patients receive oral mycophenolate mofetil 1000 mg twice daily.
Placebo Patients receive oral placebo twice daily

Measured Values
    Mycophenolate Mofetil     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  74     77  
Recurrent Malignancy  
[units: participants]
 		  17     10  


Statistical Analysis 1 for Recurrent Malignancy
Groups [1] All groups
Method [2] Regression, Cox
P Value [3] .17
Hazard Ratio (HR) [4] 1.74
95% Confidence Interval ( 0.8 to 3.9 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant information, such as adjustments or degrees of freedom:
  adjusted for risk category
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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6.  Secondary:   Non-relapse Mortality   [ Time Frame: within 4 years ]
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7.  Secondary:   Death or Recurrent Malignancy   [ Time Frame: within 4 years ]
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8.  Secondary:   Death   [ Time Frame: within 4 years ]
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9.  Secondary:   Withdrawal of Prednisone   [ Time Frame: within 4 years ]
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10.  Secondary:   End of Systemic Treatment   [ Time Frame: within 4 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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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Results Point of Contact:  
Name/Title: Paul J. Martin, M.D.
Organization: Fred Hutchinson Cancer Research Center (FHCRC)
phone: 206-667-4798
e-mail: pmartin@fhcrc.org


Publications of Results:


Responsible Party: Martin, Paul, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00089141     History of Changes
Other Study ID Numbers: 1697.00, FHCRC-1697.00, ROCHE-FHCRC-1697.00, UMN-2004UC007, CDR0000378054
Study First Received: August 4, 2004
Results First Received: July 15, 2009
Last Updated: May 1, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada