Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial

Study Overview
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Brief Summary
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The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission(CMR) while on dasatinib.

Official Title
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PhaseⅡClinical Trial of Dasatinib for Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase and Stop Therapy After Achieving Complete Molecular Response for Cure D-NewS

Conditions
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Myelogenous Leukemia, Chronic, Chronic Phase

Intervention / Treatment
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* Drug: dasatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase 15 years old over. ECOG performance status (PS) score 0-2. Adequate organ function (hepatic, renal and lung). Signed written informed consent. Exclusion Criteria: A case with the double cancer of the activity. Women who are pregnant or breastfeeding. female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: treatment<br> | Drug: dasatinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR |  | by 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 'Dasatinib affects immunological responses, as measured by flow cytometry |  | at 3,6,12,24 months | 
| Major Molecular Response(MMR) rate measured by RQ-PCR |  | by 1 months, then every 6 months for 2 years | 
| Complete Cytogenetic Response (CCyR) rate |  | by 6,12 months | 
| Progression free survival (PFS) |  | Participants were followed for at least 2 years | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Participants were followed for at least 2 years | 
| The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR |  | by 3,6 months | 
| Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse |  | by 12 months after molecular relapse | 
| Complete Molecular Response(CMR) rate measured by RQ-PCR |  | by 1 months, then every 6 months for 2 years |