Back to resultsDasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
Primary Purpose
Myelogenous Leukemia, Chronic, Chronic Phase
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
dasatinib
Sponsored by
About this trial
This is an interventional treatment trial for Myelogenous Leukemia, Chronic, Chronic Phase
Eligibility Criteria
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
Sites / Locations
- National Disaster Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
treatment
Arm Description
Outcomes
Primary Outcome Measures
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Secondary Outcome Measures
'Dasatinib affects immunological responses, as measured by flow cytometry
Major Molecular Response(MMR) rate measured by RQ-PCR
Complete Cytogenetic Response (CCyR) rate
Progression free survival (PFS)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse
Complete Molecular Response(CMR) rate measured by RQ-PCR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01887561
Brief Title
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanto CML Study Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelogenous Leukemia, Chronic, Chronic Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
dasatinib
Primary Outcome Measure Information:
Title
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Time Frame
by 12 months
Secondary Outcome Measure Information:
Title
'Dasatinib affects immunological responses, as measured by flow cytometry
Time Frame
at 3,6,12,24 months
Title
Major Molecular Response(MMR) rate measured by RQ-PCR
Time Frame
by 1 months, then every 6 months for 2 years
Title
Complete Cytogenetic Response (CCyR) rate
Time Frame
by 6,12 months
Title
Progression free survival (PFS)
Time Frame
Participants were followed for at least 2 years
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Participants were followed for at least 2 years
Title
The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR
Time Frame
by 3,6 months
Title
Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse
Time Frame
by 12 months after molecular relapse
Title
Complete Molecular Response(CMR) rate measured by RQ-PCR
Time Frame
by 1 months, then every 6 months for 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
National Disaster Medical Center
City
Tachikawa city
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoki Takesako
Phone
+81(0) 42-526-5511
Email
ntakezak@tdmc.hosp.go.jp
12. IPD Sharing Statement
Learn more about this trial
Dasatinib for Patients Achieving Complete Molecular Response for Cure D-NewS Trial
We'll reach out to this number within 24 hrs