A Study of Dasatinib as First-line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

NCT04925141 | Completed Phase 4

• 1 other identifier: YNS-2015-V1.0
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Outcome Measures

Primary Outcomes (1)

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

  MMR is defined as BCR-ABL1IS ≤ 0.1%

  up to 12 months

Secondary Outcomes (11)

• 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

• 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

• Cumulative complete cytogenic response (CCyR) rates at 12 and 24 months

  up to 24 months

Study Arms (1)

Dasatinib tablets

EXPERIMENTAL

Dasatinib tablets 100 mg orally once daily

Drug: Dasatinib Tablets

Interventions

Dasatinib Tablets DRUG

Tyrosine Kinase Inhibitor (TKI)

Dasatinib tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 0-2.
• 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".

You may not qualify if:

• 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.
• Subjects who are receiving strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, Hypericum perforatum, etc.) and the treatment cannot be stopped or replaced by other drugs before starting the study drug.
• Subjectswho are receiving the treatment of drugs that may prolong QT interval, and the treatment can not be stopped or replaced by other drugs before starting to use the study drug.
• Known or suspected to be allergic to this kind of drug.
• Female and male subjects of childbearing age who cannot use adequate methods of contraception , including pregnant or lactating women.
• Subjects who are receiving the treatment of other test drugs or participated in the clinical trial of other drugs within one month.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (4)

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, 518035, China

Location

Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

The First Affiliated Hospital, Medical College , Zhejiang University

Hangzhou, Zhejiang, 310013, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 14, 2021
• Study Start: May 10, 2016
• Primary Completion: October 22, 2018
• Study Completion: December 6, 2019
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

CN (4)