Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02268370|
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : September 20, 2017
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 require further treatment, although there may be some remaining cancer cells. Patients would normally remain on a TK inhibitor indefinitely within a standard of care setting for chronic myeloid leukemia. Within this clinical trial, patients will discontinue their TK inhibitor prematurely. If any signs of progression are identified, dasatinib will be introduced.
This research is being done because dasatinib has been shown to achieve a greater response in a much higher proportion of patients as compared to imatinib. Dasatinib is approximately 300 times more potent than imatinib, and it is possible that a greater response can be achieved by dasatinib than by imatinib.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Dasatinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment-free Remission Accomplished With Dasatinib in Patients With CML|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2021|
This research is being done because dasatinib has been shown to achieve a deep molecular response in patients as compared to imatinib.
Patients in this study will continue to take their own supply of imatinib for three months to ensure they have achieved a stable response to the drug. Once this has been confirmed, imatinib will be stopped and the patients in this study will then be monitored to see if their CML relapses. This period can last up to 2.5 years.
If the participant has a relapse, they will be started on dasatinib and will continue to receive dasatinib for up to 2 years.
If after one year they achieve a response, they will continue on dasatinib for one more year. If the participant maintains this response, they will have the option of discontinuing dasatinib.
Other Name: Sprycel
- Molecular Remission [ Time Frame: change from baseline in Molecular Profile at 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02268370
|Contact: Sima Bogomilsky, RN BSNemail@example.com|
|Tom Baker Cancer Center||Recruiting|
|Calgary, Alberta, Canada|
|Contact: Donna Forrest, M.D.|
|University of Alberta Hospital||Recruiting|
|Edmonton, Alberta, Canada|
|Contact: Elena Liew, M.D.|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: Donna Forrest, MD|
|Cancer Care Manitoba||Recruiting|
|Winnipeg, Manitoba, Canada|
|Contact: Kristjan Paulson, M.D.|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre||Recruiting|
|Halifax, Nova Scotia, Canada|
|Contact: Stephen Couban, M.D.|
|Juravinski Cancer Centre||Recruiting|
|Hamilton, Ontario, Canada|
|Contact: Brian Leber, M.D.|
|London Health Sciences Centre||Recruiting|
|London, Ontario, Canada|
|Contact: Anagyros Xenocostas, M.D.|
|Ottawa General Hospital||Recruiting|
|Ottawa, Ontario, Canada|
|Contact: Isabelle Bence-Bruckler, M.D.|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Jeffrey Lipton, M.D.|
|Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus||Recruiting|
|Charlesbourg, Quebec, Canada|
|Contact: Robert Delage, M.D.|
|Montreal, Quebec, Canada|
|Contact: Lambert Busque, M.D.|
|McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada|
|Contact: Pierre Laneuville, M.D.|
|Principal Investigator:||Dennis Kim, MD||University Health Network, Toronto|