Conditions: Chronic Myelogenous Leukemia
Keywords: Chronic Myelogenous Leukemia CML Chronic Phase Suboptimal Response
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 191
Healthy volunteers: no

Brief summary:
There is no available data on the clinical benefit of dose escalation for patients with suboptimal response to imatinib, and patients may still improve their response with continuation of therapy at the standard dose as shown in the IRIS trial after 5 years of follow-up. However, there is no data yet regarding the potential benefit of using nilotinib in the group of patients with suboptimal response. In this study, the efficacy of nilotinib 400mg BID will be compared to imatinib 600mg QD.

Detailed description:
The comparative efficacy between imatinib dose escalation (600 mg QD) and nilotinib (400 mg BID), in terms of CCyR after 6 months, for patients with CML in chronic phase with suboptimal response to imatinib standard dose will be determined.

Arms:
arm 1: Participants received 400 mg nilotinib twice daily (BID). arm 2: Participants received 600 mg imatinib once daily (QD).

Interventions: intervention 1: nilotinib intervention 2: imatinib
Intervention descriptions: intervention 1: Supplied as 200 mg tablets intervention 2: Supplied as 100 mg and 400 mg tablets

Protocol document: