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) ( 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, 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


Tom Baker Cancer Center
Donna Forrest, M.D.

University of Alberta Hospital
Elena Liew, M.D.

British Columbia
Vancouver General Hospital
Donna Forrest, M.D.

Cancer Care Manitoba
Kristjan Paulson, M.D.

Nova Scotia
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.

Hopital Maisonneuve-Rosemont
Lambert Busque, M.D.

McGill University Health Centre
Pierre Laneuville, M.D.