Efficacy and Safety of Dasatinib in the First-line Treatment of Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.4 sites in 1 country62 target enrollmentMay 10, 2016

ConditionsChronic Myelogenous Leukemia - Chronic Phase

InterventionsDasatinib Tablets

DrugsDasatinib Tablets

Overview

Phase: Phase 4
Intervention: Dasatinib Tablets
Conditions: Chronic Myelogenous Leukemia - Chronic Phase
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 62
Locations: 4
Primary Endpoint: Proportion of subjects who achieve and maintain major molecular response (MMR) at 12 months
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 10, 2016

End Date

December 6, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged ≥ 18 years and gender is not limited.
•The chronic-phased CML subjects with Ph + were definitely diagnosed within 6 months before the first use of the study drug. The diagnostic criteria refer to the 2016 edition of Chinese CML diagnosis and treatment guidelines.
•The Eastern Cooperative Oncology Group (ECOG) performance of 0-
•The function of main organs such as liver and kidney is normal, which shows that serum bilirubin is less than or equal to 1.5 × ULN； Serum ALT and AST ≤ 2.5 × ULN； Serum Cr ≤ 1.5 × ULN； Serum amylase and lipase ≤ 1.5 × ULN; Blood potassium, magnesium, phosphorus and total calcium were more than or equal to the lower limit of normal value, or were corrected to normal range before administration.
•The subjects voluntarily participate in and signed the informed consent form (ICF), and the process of signing the ICF meet the requirements of the "Practice for quality management of drug clinical trials".

Exclusion Criteria

•Subjects who have received any TKI treatment in the past.
•Subjects who have received or are receiving anti CML chemotherapy drugs (except hydroxyurea).
•Subjects who have received major surgery or no recovery from previous surgery within 4 weeks (including 4 weeks) before the first use of the study drug.
•Subjects with mental illness, including epilepsy, dementia, severe depression, mania, etc.
•Subjects with a history of significant congenital or acquired hemorrhagic disease unrelated to CML.
•Disease history and comorbidities: a) uncontrolled severe disease or active infection that impairs the subject's ability to receive the treatment; b) Uncontrolled or major cardiovascular disease; c) Pulmonary hypertension; d) Subjects with pleural effusion or pericardial effusion of any grade are excluded when screening; when entering the study, subjects with remission of pleural / pericardial effusion of any grade previously diagnosed were allowed to participate in the study.
•Subjects with gastrointestinal dysfunction or gastrointestinal diseases that may significantly affect the absorption of the test drug, such as ulcers, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, after a small bowel resection, etc.
•Cardiac dysfunction, including: a) complete left bundle branch block; b) Long QT syndrome, or known family history of long QT syndrome; c) Ventricular or atrial tachyarrhythmia of clinical significance; d) Clinically significant resting bradycardia (\< 50 beats per minute); e) QTc\>450msec； f) History of clinically confirmed myocardial infarction in the past 12 months; g) History of unstable angina in the past 12 months; h) Other clinicallysignificant heart diseases (e.g., congestive heart failure, etc.).
•Combined with other primary malignant tumors (except basal cell carcinoma of skin).
•Subjects who are receiving treatment with strong CYP3A4 inhibitors (e.g., erythromycin Ethylsuccinate, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, imipradil, etc.) and cannot discontinue or switch to other drugs before starting the study drug.

Arms & Interventions

Dasatinib tablets

Dasatinib tablets 100 mg orally once daily

Intervention: Dasatinib Tablets

Outcomes

Primary Outcomes

Proportion of subjects who achieve and maintain major molecular response (MMR) at 12 months

Time Frame: up to 12 months

MMR is defined as BCR-ABL1IS ≤ 0.1%

Secondary Outcomes

Cumulative complete cytogenic response (CCyR) rates at 12 and 24 months(up to 24 months)
Proportion of subjects who achieve and maintain MMR at 3，6 and 18 months(up to 18 months)
Time to MMR Overall(up to 24 months)
Proportion of subjects who achieve and maintain complete hematological response (CHR) at 3 months(up to 3 months)
Cumulative MMR rates at 6, 12 and 24 months(up to 24 months)
Proportion of subjects who achieve and maintain MR4.0 and MR4.5 at 6, 12 and 24 months(up to 24 months)
Event free survival (EFS)(up to 24 months)
ABL mutation rate after 6 months of treatment(up to 6 months)
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib(up to 24 months)
Progression-free Survival (PFS)(up to 24 months)
Time to accelerated phase (AP ) / blast crisis (BC)(up to 24 months)