NCT03625388

Low Dose Dasatinib (50 mg Daily) as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia

Randomized, Open-Label, Phase II, Multicenter, Multi-Country Study to Evaluate Safety and Efficacy of Dasatinib 50 mg in First-Line Treatment of Early Chronic Phase Chronic Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Hikma Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multicenter randomized study is to compare efficacy and safety of dasatinib 50 mg once daily and dasatinib 100 mg once daily in patients with early chronic phase (CP) chronic myeloid leukemia (CML)

Detailed description

A multicenter, prospective, open-label, randomized Phase II study to compare efficacy by measuring rates of major molecular response (MMR) at 12 months in patients with Ph+ chronic phase (CP) chronic myeloid leukemia (CML) randomized to receive either dasatinib 50 mg QD or dasatinib 100 mg QD. Approximately 100 patients are expected to be randomized. The duration of patient participation will be 18 months

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib	Film coated tablet contains dasatinib monohydrate

Timeline

• Start date: 2018-11-05
• Primary completion: 2023-07-22
• Completion: 2023-07-22
• First posted: 2018-08-10
• Last updated: 2023-09-22

Locations

5 sites across 4 countries: Jordan, Lebanon, Saudi Arabia, Tunisia