Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant. - Study of Nilotinib usefulness for chronic myeloid leukemia (CML) patients with Imatinib resistant or intolerant.

Osaka CML-MRD Meeting0 sites45 target enrollmentFebruary 1, 2010

Overview

No summary available.

Registry

who.int

Start Date

February 1, 2010

End Date

June 1, 2011

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Osaka CML-MRD Meeting

•1\) accelerating phase(AP) patients with following one or more condition or suspected blast phase (BC) patients AP: \-blast rate \>\= 15% in peripheral blood or bone marrow, and \< 30% in both peripheral blood and bone marrow \-blast \+ promyelocyte : \>\= 30% in peripheral blood or bone marrow \-basophil rate: \>\= 20% in peripheral blood \-platelet: continuous decline on treatment independently (\<\= 10,000 / cubic millimeter) BC: \-blast: \>\= 30% in peripheral blood or bone marrow \-No blast increase extramedullary except hepatosplenomegaly proven by biopsy 2\) No drug history of Hydrea or IFN\-alpha as CML treatment 3\) Class 3, 4 in NYHA 4\) Double invasive cancer within 5 years before beginning of otinib 5\) Uncontrollable disease complication 6\) Diagnosed HIV 7\) patients during pregnancy or possible in pregnancy 8\) Patients during lactation or expecting pregnancytients 9\) Patients with psychiatric disease or psychological symptom