Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD)

November 27, 2019 updated by: University Health Network, Toronto

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Center
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Cancer Care Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • Ottawa General Hospital
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Charlesbourg, Quebec, Canada
        • Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus
      • Montreal, Quebec, Canada
        • Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada
        • McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dasatinib

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 Names:
  • Sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Molecular Remission
Time Frame: change from baseline in Molecular Profile at 12 months
change from baseline in Molecular Profile at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Ozmosis Research Inc.

Investigators

  • Principal Investigator: Dennis Kim, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS CA180-543
  • OZM-056 (Other Identifier: Ozmosis Research Inc.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Myeloid Leukemia

Clinical Trials on Dasatinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe