Status:
UNKNOWN
Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Ozmosis Research Inc.
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 re...
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 inhibit...
Eligibility Criteria
Inclusion
- Diagnosis of CML
- Treatment of chronic phase CML treated for a minimum of three years exclusively with imatinib
- Levels of BCR-ABL by RQ-PCR with ≥ 4.5 log reduction from baseline
- Provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Age \>18 years.
- Adequate organ liver and renal functions
- Normal serum levels (within normal limits)
Exclusion
- Prior treatment with a TKI (except for imatinib, hydroxyurea, anagrelide or interferon)
- Taking any medications or substances known to affect CYP3A4.
- Concurrent medical condition which may increase the risk of toxicity
- History of significant bleeding disorder unrelated to cancer
- Cardiac Symptoms
- Clinically significant hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT02268370
Start Date
October 1 2014
End Date
October 1 2021
Last Update
November 29 2019
Active Locations (12)
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1
Tom Baker Cancer Center
Calgary, Alberta, Canada
2
University of Alberta Hospital
Edmonton, Alberta, Canada
3
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
4
Cancer Care Manitoba
Winnipeg, Manitoba, Canada