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

Phase 4

• Conditions: Chronic Myeloid Leukemia; Dasatinib; BCR-ABL
• Interventions: Drug: Dasatinib

• Registration Number: NCT04155411
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2019-12-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dasatinib 70 mg	Dasatinib	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test	12 months	Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1%

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with MR 4.0 at 12 months.	12 months	Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01%
Incidence of adverse events (AEs) and serious adverse events (SAEs) to dasatinib	18 months	Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges
Proportion of patients with MR 4.5 at 12 months.	12 months	Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032%
Proportion of patients with Complete cytogenetic response (CCyR) at 12 months	12 months	defined as 0% Ph+ metaphases, or FISH ≤2%, or BCR-ABL transcripts (IS) ≤1%

Trial Locations

Locations (1)

Xin Du; 🇨🇳 Shenzhen, Guangdong, China