NCT01887561UnknownPhase 2
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
Kanto CML Study Group1 site in 1 country100 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase
- •15 years old over.
- •ECOG performance status (PS) score 0-
- •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
Arms & Interventions
treatment
No Intervention
Intervention: dasatinib (Drug)
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(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)
Investigators
Naoki Takezako, M.D., Ph.D.
Kanto CML Study Group
Kanto CML Study Group
Study Sites (1)
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