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

Shenzhen University

Status and phase

Enrolling

Phase 4

Conditions

BCR-ABL

Chronic Myeloid Leukemia

Dasatinib

Treatments

Drug: Dasatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT04155411

20191103

Details and patient eligibility

About

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).

Full 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.

Enrollment

65 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years.
Diagnosis of Ph+ or BCR-ABL positive CML-CP within 6 months.
ECOG performance of 0-2.
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.
Pregnant or breast-feeding women are excluded.
Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.