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

Phase 2

• Conditions: Chronic myeloid leukemia

• Registration Number: JPRN-UMIN000003016
• Lead Sponsor: Osaka CML-MRD Meeting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-01
• Study Completion: 2011-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified