Nilotinib-Chemotherapy in CML Myeloid BP or Bcr-abl(+) AML
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
The current standard therapy in previously untreated adults with chronic phase (CP) of CML is
imatinib and the result of long-term follow-up of IRIS study proves that imatinib for CML CP
is reasonable therapy.(1, 2) However, some patients were initially diagnosed as advanced CML,
accelerated phase (AP) or blastic phase (BP). Various chemotherapies were tried and were
found that there were no highly effective chemotherapies for CML BP.(3-11) Imatinib in
patients with these advanced CML is also disappointing because of low response rates as well
as short response duration, and sudden transformation to BC is found even in initial CML CP
patients. (12-17). Recent studies showed that nilotinib or dasatinib is better than imatinib
in terms of rapid response and higher molecular response in newly diagnosed CML
patients.(18-21) More potent bcr-abl suppression of nilotinib is supposed to be more active
than imatinib even in patients with advanced CML. However, nilotinib in patients with
imatinib-resistant or -intolerant CML BP showed low hematologic response and major
cytogenetic response.(22, 23)
Phase:
Phase 2
Details
Lead Sponsor:
Ulsan University Hospital
Collaborator:
The Korean Society of Hematology CML working party