NCT02268370

Treatment-free Remission Accomplished With Dasatinib in Patients With CML

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out how to increase the potential for achieving an "operational cure" from chronic myeloid leukemia. An "operational cure" is a state in which a person does not require further treatment, although there may be some remaining cancer cells. Patients would normally remain on a TK inhibitor indefinitely within a standard of care setting for chronic myeloid leukemia. Within this clinical trial, patients will discontinue their TK inhibitor prematurely. If any signs of progression are identified, dasatinib will be introduced. This research is being done because dasatinib has been shown to achieve a greater response in a much higher proportion of patients as compared to imatinib. Dasatinib is approximately 300 times more potent than imatinib, and it is possible that a greater response can be achieved by dasatinib than by imatinib.

Detailed description

This is an open label, single arm Phase II trial that will examine how safe and effective it will be for patients with chronic myeloid leukemia (CML) to discontinued first line tyrosine kinase inhibitor (TKI) therapy. The main goal of this study is to determine the potential role of dasatinib (the study drug) in helping patients with CML attain a sustained treatment free remission. During this study the safety and tolerability of Dasatinib will be evaluated by means of drug related toxicity, adverse event reports, physical examinations and laboratory safety evaluations. The study period for an individual patient is expected to be approximately between 30-72 months. A total of 135 patients will be recruited from 10 Canadian centres.

Conditions

• Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Dasatinib

Timeline

• Start date: 2014-10-01
• Primary completion: 2020-10-01
• Completion: 2021-10-01
• First posted: 2014-10-20
• Last updated: 2019-11-29

Locations

12 sites across 1 country: Canada