Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 135
Summary
- Conditions
- Chronic Myeloid Leukemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 s...
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.
Tracking Information
- NCT #
- NCT02268370
- Collaborators
- Ozmosis Research Inc.
- Investigators
- Principal Investigator: Dennis Kim, MD University Health Network, Toronto
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