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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
70 mg of Dasatinib orally daily for 12 months
Xin Du
Shenzhen, Guangdong, China
RECRUITINGProportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%
Time frame: 12 months
Proportion of patients with MR 4.0 at 12 months.
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%
Time frame: 12 months
Proportion of patients with MR 4.5 at 12 months.
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%
Time frame: 12 months
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months
defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%
Time frame: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Time frame: 18 months
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