The purpose of this multicenter,open, prospective and single arm study is to evaluate the efficacy and safety of domestic dasatinib in the first-line treatment of newly diagnosed CML-CP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Tyrosine Kinase Inhibitor (TKI)
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, Medical College , Zhejiang University
Hangzhou, Zhejiang, China
Proportion of subjects who achieve and maintain major molecular response (MMR) at 12 months
MMR is defined as BCR-ABL1IS ≤ 0.1%
Time frame: up to 12 months
Proportion of subjects who achieve and maintain MMR at 3,6 and 18 months
MMR is defined as BCR-ABL1IS ≤ 0.1%
Time frame: up to 18 months
Time to MMR Overall
The time to MMR for all participants is defined as the time from first use of the study drug until measurement criteria are first met for MMR.
Time frame: up to 24 months
Cumulative MMR rates at 6, 12 and 24 months
MMR is defined as BCR-ABL1IS ≤ 0.1%
Time frame: up to 24 months
Proportion of subjects who achieve and maintain MR4.0 and MR4.5 at 6, 12 and 24 months
MR4.0 is defined as BCR-ABL1IS ≤ 0.01%, MR4.5 is defined as BCR-ABL1IS ≤ 0.0032%
Time frame: up to 24 months
Cumulative complete cytogenic response (CCyR) rates at 12 and 24 months
CCyR is defined as 0% Ph+ metaphases
Time frame: up to 24 months
Proportion of subjects who achieve and maintain complete hematological response (CHR) at 3 months
CHR was defined as peripheral blood WBC \< 10x109 / L, PLT \< 450x109 / L, no immature granulocytes, basophils \< 0.05, no symptoms and signs of CML, spleen untouchable
Time frame: up to 3 months
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Time to accelerated phase (AP ) / blast crisis (BC)
Time to AP / BC is defined as the time from the first use of the study drug to the date of CML related death or progression to AP or BC, whichever occurs first. For subjects without these events, the event was truncated at the date of the last evaluation (Hematology, extramedullary disease, or cytogenetic evaluation)
Time frame: up to 24 months
Progression-free Survival (PFS)
PFS is defined as the time from the first use of the study drug to the earliest occurrence of the following events: death from any cause (if death was the main cause of discontinuation) or progression to AP or BC.
Time frame: up to 24 months
Event free survival (EFS)
EFS is defined as the time from the first use of the study drug to the earliest occurrence of the following events during the study treatment: loss of CHR, loss of PCyCR, loss of CCyR, death from any cause during the treatment, and progression to AP or BC
Time frame: up to 24 months
ABL mutation rate after 6 months of treatment
The proportion of ABL mutations in subjects with BCR-ABL1IS \> 1% or disease progression after 6 months of treatment
Time frame: up to 6 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib
Evaluation of AEs, SAEs, and clinically relevant changes in laboratory tests according to laboratory reference ranges
Time frame: up to 24 months