TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]
Type of study
Treatment discontinuation trial
No longer recruiting
What is the purpose of the study
Study participants will stop taking imatinib if they have reached deep molecular response after at least 3 years of treatment. They will then be monitored for up to 2.5 years to see if they remain well without any treatment at all. Patients who have a relapse will be given dasatinib for up to 2 years. Patients who achieve a response and maintain a response on dasatinib will have the option of discontinuing dasatinib.
What will happen during the study
Key inclusion criteria
This study includes patients who:
– have chronic myeloid leukemia in chronic phase
– have been treated with first line imatinib for at least 3 years
– are in deep molecular remission (MR4.5) at study entry
– are at least 18 years old
– have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
– have adequate kidney and liver function
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
University Health Network, Toronto, Canada
Scientific lead / contact
Dennis Kim, M.D., University Health Network, Toronto
Contact: Sima Bogomilsky
Dennis Kim, M.D.
University Health Network
Study centers / principal investigators
Tom Baker Cancer Center
Donna Forrest, M.D.
University of Alberta Hospital
Elena Liew, M.D.
Vancouver General Hospital
Donna Forrest, M.D.
Cancer Care Manitoba
Kristjan Paulson, M.D.
Queen Elizabeth II Health Sciences Centre
Stephen Couban, M.D.
Juravinski Cancer Centre
Brian Leber, M.D.
London Health Sciences Centre
Anagyros Xenocostas, M.D.
Ottawa General Hospital
Isabelle Bence-Bruckler, M.D.
Princess Margaret Cancer Centre
Jeffrey Lipton, M.D.
Centre Hôpitallier Universitaire de Quebec – Hôpital de l’Enfant-Jésus
Robert Delage, M.D.
Lambert Busque, M.D.
McGill University Health Centre
Pierre Laneuville, M.D.