A Study of Complete Molecular Response for Chronic Myeloi... | NCT01342679

Studies
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

NCT01342679

Sponsor

Kanto CML Study Group

Status

Completed

Last Update Posted

Sep 15, 2015Estimated

Enrollment

21Actual

Phase

Phase 2

Conditions

Chronic Myeloid Leukemia

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

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Apr 25, 2011

First Submission Date that Met QC Criteria

Apr 26, 2011

First Posted Date

Apr 27, 2011Estimated

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

Sep 14, 2015

Last Update Posted Date

Sep 15, 2015Estimated

Name	Class
Epidemiological and Clinical Research Information Network	OTHER

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

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

21Actual

Label	Type	Description	Intervention Names
dasatinib	Experimental		Drug: dasatinib

Name	Type	Description	Arm Group Labels	Other Names
dasatinib	Drug	100mg QD	dasatinib	BMS-354825

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of complete molecular response (CMR) after treatment with dasatinib		at 12 months

Secondary Outcomes

Measure	Description	Time Frame
Dasatinib of dose intensity		at 12 months
Expansions rate of large granular lymphocyte		at 12 months
Progression free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic Myeloid Leukemia in the Chronic Phase
20 years old over
ECOG performance status (PS) score 0-2
Patients for major molecular response (MMR) with no CMR
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
The case of Pleural effusion clearly
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 suspected congenital QT syndrome
- 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
Prior treatment with dasatinib
Subjects with T315I, F317L and V299L BCR-ABL point mutations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chikashi Yoshida, MD, PhD	National Hospital Organization, Mito Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital		Bunkyo-ku	Tokyo	113-8677	Japan

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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