Conditions: Chronic Myelogenous Leukemia in Chronic Phase
Keywords: CML Chronic Myelogenous Leukemia Leukemia CML-CP Nilotinib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 128
Healthy volunteers: no

Brief summary:
"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

Detailed description:

Arms:
arm 1: Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.

Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Protocol document: