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

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    Shenzhen Second People's Hospital
Updated on 4 October 2022


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).


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.

Condition Dasatinib, BCR-ABL, Chronic Myeloid Leukemia
Treatment dasatinib
Clinical Study IdentifierNCT04155411
SponsorShenzhen Second People's Hospital
Last Modified on4 October 2022


Yes No Not Sure

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
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