PRIMARY OBJECTIVES: Determine the safety and tolerability of nilotinib in steroid dependent / refractory cGVHD. SECONDARY OBJECTIVES: Determine the clinical efficacy of nilotinib in steroid dependent / refractory cGVHD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
200, 400, 800, oral
Stanford University School of Medicine
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Frequency and severity of adverse events graded according to CTCAE v4.0
Time frame: 2 years
Chronic GVHD response measured as change in physical exam and laboratory testing
Time frame: baseline and 2 years
Chronic GVHD response measured as change in daily corticosteroid requirement
Time frame: baseline and 2 years
Chronic GVHD response measured as frequency of treatment failure defined as discontinuation of study drug due to severe adverse effects or initiation of a new treatment for cGVHD
Time frame: 2 years
Chronic GVHD response measured as change in cGVHD symptom burden
Time frame: baseline and 2 years
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Gordon and Leslie Diamond Health Care Centre Hematology Administration
Vancouver, British Columbia, Canada