drugset / Trial / NCT03942094
Nilotinib for First-line Newly Diagnosed CML-CP Patients
Phase 3
Unknown
100 enrolled
Shenzhen Second People's Hospital
Affiliated Hospital of Guangdong Medical University · collabDongguan People's Hospital · collabHuazhong University of Science and Technology Union Shenzhen Hospital · collabLonggang District People's Hospital of Shenzhen · collabZhongshan People's Hospital, Guangdong, China · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2019-06-01
- Primary completion
- 2023-06-01
- Completion
- 2023-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nilotinib | Small molecule | 300 mg | Oral |