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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dasatinib, BCR-ABL, Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dasatinib 70 mg<br> | Drug: Dasatinib<br>* 70 mg of Dasatinib orally daily for 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dasatinib, CML-CP