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

Kanto CML Study Group100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Myelogenous Leukemia, Chronic, Chronic Phase

Interventions

dasatinibDRUG

Eligibility

Sex: ALLMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Disaster Medical Center

Tachikawa, Tokyo, Japan

RECRUITING

Outcomes

Primary Outcomes

The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR

Time frame: by 12 months

Secondary Outcomes

'Dasatinib affects immunological responses, as measured by flow cytometry

Time frame: at 3,6,12,24 months

Major Molecular Response(MMR) rate measured by RQ-PCR

Time frame: by 1 months, then every 6 months for 2 years

Complete Cytogenetic Response (CCyR) rate

Time frame: by 6,12 months

Progression free survival (PFS)

Time frame: Participants were followed for at least 2 years

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 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

Time frame: by 3,6 months

Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse

Time frame: by 12 months after molecular relapse

Complete Molecular Response(CMR) rate measured by RQ-PCR

Time frame: by 1 months, then every 6 months for 2 years

Data from ClinicalTrials.gov

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