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DASFREE

Open-Label Study Evaluating Dasatinib Therapy Discontinuation in Patients With Chronic Phase Chronic Myeloid Leukemia With Stable Complete Molecular Response.
Recruitment period: 
1 February 2014 to 1 May 2020
Trial period: 
1 February 2014 to 1 May 2020
Clinical Trial reference link: 
NCT01850004

Treatments:

For newly diagnosed patients: 
no

Primary purpose

  • MMR rate measured by the proportion of enrolled subjects who maintain MMR 12 months after Dasatinib discontinuation compared with the enrolled subjects in the study [ Time Frame: Every 3 months in years 2 to 5 ] [ Designated as safety issue: No ]
  • MMR rate measured by the proportion of enrolled subjects who maintain MMR 12 months after Dasatinib discontinuation compared with the enrolled subjects in the study [ Time Frame: Monthly once up to first year ] [ Designated as safety issue: No ]
  • Major Molecular Response (MMR) is defined as BCR-ABL transcripts <0.1% on International Scale, at 12 month after Dasatinib discontinuation in patients who have maintained MMR without re-starting Dasatinib

Protocol designed to evaluate remission of disease after treatment discontinuation. Treatment re-started if relapse occurs.

This study is currently recruiting (see Contacts and Locations)

Verified: February 2014 by Bristol-Myers Squibb

Sponsor: Bristol-Myers Squibb

Information provided by (Responsible Party): Bristol-Myers Squibb

 

Estimated Enrollment: 79

Study Start Date: February 2014

Estimated Study Completion Date: May 2020

Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Contacts and Locations: United States, Canada, Finland, France, Germany, Italy, Spain