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

Phase 2

• Conditions: Myelogenous Leukemia, Chronic, Chronic Phase
• Interventions: Drug: dasatinib

• Registration Number: NCT01887561
• Lead Sponsor: Kanto CML Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2012-12
• Study First Submitted: 2013-04-11
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-24
• Last Update Submitted: 2013-06-24
• Study First Posted: 2013-06-27
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	dasatinib	-

Primary Outcome Measures

Name	Time	Method
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR	by 12 months

Secondary Outcome Measures

Name	Time	Method
'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
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
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR	by 3,6 months

Trial Locations

Locations (1)

National Disaster Medical Center; 🇯🇵 Tachikawa city, Tokyo, Japan