Clinical Trial: A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
Brief Summary: To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.
Detailed Summary:
Sponsor: Stanford University
Current Primary Outcome: The frequency of adverse events graded according to the CTCAE will be the primary endpoint [ Time Frame: Subjects will be monitored at 1, 4, 8, 16, and 24 weeks. ]
Original Primary Outcome: Determine the safety and tolerability of imatinib in steroid refractory cGVHD
Current Secondary Outcome:
Original Secondary Outcome:
- Determine the overall response rate of steroid refractory cGVHD to imatinib.
- Determine the treatment failure rate of imatinib for steroid refractory cGVHD.
- Assess steroid reduction as a surrogate for cGVHD response to imatinib.
- Evaluate subject reported quality of life outcomes.
Information By: Stanford University
Dates:
Date Received: September 25, 2008
Date Started: September 2008
Date Completion: December 2009
Last Updated: February 17, 2010
Last Verified: February 2010
