TRAD = Treatment-free Remission Accomplished With Dasatinib in Patients With CML [Canada]
Study title
Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD) [Canada]
Scientific title
Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD) (ClinicalTrials.gov No. NCT02268370)
Type of study
Treatment discontinuation trial
Current status
No longer recruiting
What is the purpose of the study
This trial will evaluate how safe and effective it will be for patients with chronic myeloid leukemia (CML) to discontinue first line treatment with imatinib.
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.
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
Study sponsor
University Health Network, Toronto, Canada
Scientific lead / contact
Dennis Kim, M.D., University Health Network, Toronto
Contact: Sima Bogomilsky
Principal investigator
Dennis Kim, M.D.
University Health Network
Toronto, Canada
Study centers / principal investigators
Canada
Alberta
Calgary
Tom Baker Cancer Center
Donna Forrest, M.D.
Edmonton
University of Alberta Hospital
Elena Liew, M.D.
British Columbia
Vancouver
Vancouver General Hospital
Donna Forrest, M.D.
Manitoba
Winnigpeg
Cancer Care Manitoba
Kristjan Paulson, M.D.
Nova Scotia
Halifax
Queen Elizabeth II Health Sciences Centre
Stephen Couban, M.D.
Ontario
Hamilton
Juravinski Cancer Centre
Brian Leber, M.D.
London
London Health Sciences Centre
Anagyros Xenocostas, M.D.
Ottawa
Ottawa General Hospital
Isabelle Bence-Bruckler, M.D.
Toronto
Princess Margaret Cancer Centre
Jeffrey Lipton, M.D.
Quebec
Charlesbourg
Centre Hôpitallier Universitaire de Quebec – Hôpital de l’Enfant-Jésus
Robert Delage, M.D.
Montreal
Hopital Maisonneuve-Rosemont
Lambert Busque, M.D.
Montreal
McGill University Health Centre
Pierre Laneuville, M.D.