98
Participants
Start Date
March 31, 2013
Primary Completion Date
August 31, 2016
Study Completion Date
August 31, 2016
Nilotinib 300 mg.
"Patients diagnosed with chronic myeloid leukemia receiving treatment of Imatinib 400 mg once a day but are determined to be sub-optimally responding to Imatinib therapy as per the ELN 2013 guidelines will be switched to Nilotinib 300 mg BID and then will be assessed for therapy response. ELN guidelines 2013 for imatinib therapy response states as:~Minor cytogenetic response mCyR or minimal response at 3 months (Ph+ metaphases in BM 35 to 95 %); BCR-ABL1 transcript \> 10% at 3 months; Partial cytogenetic response at 6 months Ph+ metaphases in BM 0to 35); BCR-ABL1 transcript is 1 to 10% at 6 months. Less than a major molecular response at \> 12 months; i.e (BCR-ABL1 0.1 -1%)"
National Guard Hospital, Riyadh
King Fahad specialist Hospital, Dammam
Collaborators (1)
Novartis
INDUSTRY
King Abdullah International Medical Research Center
OTHER