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

NCT ID: NCT04155411

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2023-12-01

Brief Summary

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).

Detailed Description

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.

Conditions

Dasatinib; BCR-ABL; Chronic Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dasatinib 70 mg

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

70 mg of Dasatinib orally daily for 12 months

Interventions

Dasatinib

70 mg of Dasatinib orally daily for 12 months

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xin Du

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Du

Role: CONTACT

duxingz@medmail.com.cn

075583366388

Facility Contacts

Xin Du, PHD

Role: primary

Other Identifiers

20191103

Identifier Type: -

Identifier Source: org_study_id