Nilotinib for First-line Newly Diagnosed CML-CP Patients
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Shenzhen Second People's Hospital
Collaborators:
Affiliated Hospital of Guangdong Medical University Dongguan People's Hospital Huazhong University of Science and Technology Union Shenzhen Hospital Longgang District Central Hospital of Shenzhen Zhongshan City People's Hospital