NCT03942094

Nilotinib for First-line Newly Diagnosed CML-CP Patients

Efficacy and Safety of Nilotinib as the First-line Treatment for Patients With Newly Diagnosed Chronic-phase Chronic Myeloid Leukemia: a Prospective Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IIIb, multi-centre, single-arm, open-label, prospective study investigating the efficacy and safety of nilotinib as the first-line treatment for the adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP) in China. Nilotinib 300 mg BID will be provided in this study. The assessment for the primary efficacy endpoint will be performed at 18 months and the rate of patients obtaining MR4.5 will be measured at this time point. Secondary endpoints include the complete hematologic response(CHR) and the rates of major molecular reactions (MMR) by 3, 6, 9,12,18 and 24 months; event free survival (EFS); overall survival (OS).

Conditions

• Chronic Myeloid Leukemia, Chronic Phase
• Nilotinib

Interventions

Type	Name	Description
DRUG	Nilotinib	Nilotinib (Tasigna ®), capsules of 150 mg Nilotinib 2 capsules of 150 mg, orally, twice daily

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2019-05-08
• Last updated: 2022-03-16

Locations

1 site across 1 country: China