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. Identifier: NCT02268370
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : September 20, 2017
Ozmosis Research Inc.
Information provided by (Responsible Party):
University Health Network, Toronto

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 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

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 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)
Primary Purpose: Other
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

Arm Intervention/treatment

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.

Drug: Dasatinib
Other Name: Sprycel

Primary Outcome Measures :
  1. Molecular Remission [ Time Frame: change from baseline in Molecular Profile at 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of CML
  2. Treatment of chronic phase CML treated for a minimum of three years exclusively with imatinib
  3. Levels of BCR-ABL by RQ-PCR with ≥ 4.5 log reduction from baseline
  4. Provide written informed consent
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. Age >18 years.
  7. Adequate organ liver and renal functions
  8. Normal serum levels (within normal limits)

Exclusion Criteria:

  1. Prior treatment with a TKI (except for imatinib, hydroxyurea, anagrelide or interferon)
  2. Taking any medications or substances known to affect CYP3A4.
  3. Concurrent medical condition which may increase the risk of toxicity
  4. History of significant bleeding disorder unrelated to cancer
  5. Cardiac Symptoms
  6. Clinically significant hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration

Information from the National Library of Medicine

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 identifier (NCT number): NCT02268370

Contact: Sima Bogomilsky, RN BSN 416-946-4646

Canada, Alberta
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         
Canada, Manitoba
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.         
Canada, Ontario
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.         
Canada, Quebec
Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus Recruiting
Charlesbourg, Quebec, Canada
Contact: Robert Delage, M.D.         
Hopital Maisonneuve-Rosemont Recruiting
Montreal, Quebec, Canada
Contact: Lambert Busque, M.D.         
McGill University Health Centre Recruiting
Montreal, Quebec, Canada
Contact: Pierre Laneuville, M.D.         
Sponsors and Collaborators
University Health Network, Toronto
Ozmosis Research Inc.
Principal Investigator: Dennis Kim, MD University Health Network, Toronto

Responsible Party: University Health Network, Toronto Identifier: NCT02268370     History of Changes
Other Study ID Numbers: BMS CA180-543
OZM-056 ( Other Identifier: Ozmosis Research Inc. )
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action