Graft Versus Host Disease Clinical Trial
Official title:
Efficacy and Safety of Nilotinib in Patients With a Chronic Disease of the Graft Against the Host (Graft Versus Host, GVH) Did Not Respond to Imatinib Mesylate.
Open label non-randomized multicenter phase 2 trial with direct individual benefice
Induction phase: Imatinib mesylate - starting with 100 mg/day with increase of 100 mg/day
each other week up to maximum tolerable dose or 400 mg/day whichever occurred first. For the
responders and in absence of toxicity, the treatment will be maintained up to one year.
Patients, who discontinue imatinib mesylate at 3 months for lack of response (no response =
stable disease), those who experience progression at any time, those who relapse after an
initial response at any time or those who discontinue for toxicity at any time, will go to
the salvage phase.
Salvage phase:
Nilotinib - starting with 200 mg/day with increase of 200 mg/day each other week up to
maximum tolerable dose or 800 mg/day whichever occurred first. In absence of toxicity, the
treatment will be maintained up to one year.
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