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

Myelogenous Leukemia, Chronic, Chronic Phase Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01887561
• Other study ID #: KCSG-04
• Status: Recruiting
• Phase: Phase 2
• First received: April 11, 2013
• Last updated: June 24, 2013
• Start date: November 2012

Study information

• Verified date: June 2013
• Source: Kanto CML Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase
• Myelogenous Leukemia, Chronic, Chronic Phase

Intervention

Drug:
• dasatinib

Locations

Country	Name	City	State
Japan	National Disaster Medical Center	Tachikawa city	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kanto CML Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR		by 12 months	No
Secondary	'Dasatinib affects immunological responses, as measured by flow cytometry		at 3,6,12,24 months	No
Secondary	Major Molecular Response(MMR) rate measured by RQ-PCR		by 1 months, then every 6 months for 2 years	No
Secondary	Complete Cytogenetic Response (CCyR) rate		by 6,12 months	No
Secondary	Progression free survival (PFS)		Participants were followed for at least 2 years	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Participants were followed for at least 2 years	Yes
Secondary	The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR		by 3,6 months	No
Secondary	Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse		by 12 months after molecular relapse	No
Secondary	Complete Molecular Response(CMR) rate measured by RQ-PCR		by 1 months, then every 6 months for 2 years	No