Text Size

Imatinib Mesylate to Treat Skin Changes in Patients With Chronic Graft-Versus-Host Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00702689
First received: June 19, 2008
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
Results First Received: September 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Sclerotic Graft Versus Host Disease
Imatinib Mesylate
Intervention: Drug: Gleevec, STI571(Imatinib Mesylate)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Imatinib Mesylate in Patients With cGVHD

Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.

Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)

Participant Flow:   Overall Study
    Imatinib Mesylate in Patients With cGVHD  
STARTED     20  
COMPLETED     14  
NOT COMPLETED     6  
Withdrawal by Subject                 4  
Recurrent malignancy                 1  
Adverse Event                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Imatinib Mesylate in Patients With cGVHD

Cohort 1 - Pts 1-8:Adults: 400mg imatinib mesylate daily; Children: 260mg/m^2 daily (400mg maximum), followed by dose de-escalation for adverse events.

Cohort 2 - Pts 9-20:Adults - 100 mg oral dose daily (increase to 200 mg daily after 28 days if well tolerated). Children - 65 mg/m^2 oral dose daily (increase to 130 mg/m^2 daily after 28 days if well tolerated)

Baseline Measures
    Imatinib Mesylate in Patients With cGVHD  
Number of Participants  
[units: participants]
 		  20  
Age  
[units: participants]
 		 
<=18 years     2  
Between 18 and 65 years     18  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.59  ± 17.49  
Gender  
[units: participants]
 		 
Female     6  
Male     14  
Ethnicity (NIH/OMB)  
[units: Participants]
 		 
Hispanic or Latino     3  
Not Hispanic or Latino     17  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 		 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     19  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 		 
United States     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Absolute Range of Motion (ROM) From Baseline to 6 Months   [ Time Frame: 6 months ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 41 months, 27 days ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


Results Point of Contact:  
Name/Title: Edward Cowen, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-496-4299
e-mail: cowene@mail.nih.gov


No publications provided


Responsible Party: Edward W. Cowen, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier: NCT00702689     History of Changes
Other Study ID Numbers: 080148, 08-C-0148
Study First Received: June 19, 2008
Results First Received: September 5, 2012
Last Updated: October 17, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration