Dasatinib for Patients Achieving Complete Molecular Respo... | NCT01887561

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

NCT01887561

Sponsor

Kanto CML Study Group

Status

Unknown status

Last Update Posted

Jun 27, 2013Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Myelogenous Leukemia, Chronic, Chronic Phase

Interventions

dasatinib

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Not provided

First Submitted Date

Apr 11, 2013

First Submission Date that Met QC Criteria

Jun 24, 2013

First Posted Date

Jun 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2013

Last Update Posted Date

Jun 27, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
treatment	No Intervention		Drug: dasatinib

Name	Type	Description	Arm Group Labels	Other Names
dasatinib	Drug		treatment

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Disaster Medical Center	Recruiting	Tachikawa	Tokyo	190-0014	Japan

Condition Browse Module

MeSH Terms

ID	Term
D015466	Leukemia, Myeloid, Chronic-Phase

Ancestor Terms

ID	Term
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069439	Dasatinib

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

Not provided