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

Shenzhen Second People's Hospital1 site in 1 country65 target enrollmentDecember 1, 2019

ConditionsDasatinib BCR-ABL Chronic Myeloid Leukemia

InterventionsDasatinib

DrugsDasatinib

Overview

Phase: Phase 4
Intervention: Dasatinib
Conditions: Dasatinib
Sponsor: Shenzhen Second People's Hospital
Enrollment: 65
Locations: 1
Primary Endpoint: Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 1, 2019

End Date

December 1, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shenzhen Second People's Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years.
•Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months.
•ECOG performance of 0-
•Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
•Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital

Exclusion Criteria

•History of any TKI treatments.
•History of Pulmonary arterial hypertension and Pleural effusion
•NYHA cardiac class 3-4 heart disease.
•Cardiac symptoms - Patients meeting the following criteria are not eligible unless cleared by a cardiologist:
•Uncontrolled angina within 12 months.
•Diagnosed or suspected congenital long QT syndrome.
•Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes).
•Prolonged QTc interval on pre-entry electrocardiogram (\>450 msec).
•Patients with active uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
•Women of pregnancy potential must practice an effective method of birth control, unless otherwise instructed, during the course of the study in a manner such that risk of failure is minimized.

Arms & Interventions

Dasatinib 70 mg

Intervention: Dasatinib

Outcomes

Primary Outcomes

Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test

Time Frame: 12 months

Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%

Secondary Outcomes

Proportion of patients with MR 4.0 at 12 months.(12 months)
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib(18 months)
Proportion of patients with MR 4.5 at 12 months.(12 months)
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months(12 months)