NCT01227577

CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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."

Conditions

• Chronic Myelogenous Leukemia in Chronic Phase

Interventions

Type	Name	Description
DRUG	Nilotinib	Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2010-10-25
• Last updated: 2016-02-08
• Results posted: 2016-02-08

Locations

32 sites across 1 country: United States