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

Chronic Myeloid Leukemia Clinical Trial

Official title:

Efficacy and Safety of Dasatinib 70 mg as First-Line Treatment for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia (CML-CP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155411
• Other study ID #: 20191103
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2022
• Source: Shenzhen Second People's Hospital
• Contact: Xin Du
• Phone: 075583366388
• Email: duxingz[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

• Patients in late chronic phase (i.e. time from diagnosis to treatment >12 months), accelerated phase (except as noted in inclusion criteria 2) or blast phase are excluded.

Related Conditions & MeSH terms

• BCR-ABL
• Chronic Myeloid Leukemia
• Dasatinib
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Dasatinib
70 mg of Dasatinib orally daily for 12 months

Locations

Country	Name	City	State
China	Xin Du	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion 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%	12 months
Secondary	Proportion of patients with MR 4.0 at 12 months.	Molecular response (MR) 4.0 is defined as BCR-ABL transcripts = 0.01%	12 months
Secondary	Proportion of patients with MR 4.5 at 12 months.	Molecular response (MR) 4.5 is defined as BCR-ABL transcripts = 0.0032%	12 months
Secondary	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%	12 months
Secondary	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	18 months