Efficacy and Safety Assessment of NIlotinib in CML Patients With Suboptimal Response on Imatinib Therapy

PHASE4TerminatedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Myeloid Leukemia, Chronic
Interventions
DRUG

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%)"

Trial Locations (2)

11426

National Guard Hospital, Riyadh

Unknown

King Fahad specialist Hospital, Dammam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

King Abdullah International Medical Research Center

OTHER