NCT04155411

Dose Reduced Dasatinib (70 mg Daily) as First-line Treatment for Newly Diagnosed CML-CP

Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Shenzhen Second People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy and safety of dasatinib 70 mg once daily as first line therapy in patients with early chronic phase (CP) chronic myeloid leukemia (CML).

Detailed description

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of 70mg dasatinib by measuring rates of major molecular response (MMR) at 12 months in patients with CML-CP in China. Approximately 65 Patients will be recruited consecutively from the study sites during the enrollment period and will be given dasatinib 70 mg QD. The duration of patient participation will be 12 months.

Conditions

• Dasatinib
• BCR-ABL
• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	70 mg of Dasatinib orally daily for 12 months

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2019-11-07
• Last updated: 2022-07-27

Locations

1 site across 1 country: China