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

Primary Purpose

Chronic Myeloid Leukemia

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tom Baker Cancer Center
  • University of Alberta Hospital
  • Vancouver General Hospital
  • Cancer Care Manitoba
  • Queen Elizabeth II Health Sciences Centre
  • Juravinski Cancer Centre
  • London Health Sciences Centre
  • Ottawa General Hospital
  • Princess Margaret Cancer Centre
  • Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus
  • Hopital Maisonneuve-Rosemont
  • McGill University Health Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dasatinib

Arm Description

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.

Outcomes

Primary Outcome Measures

Molecular Remission

Secondary Outcome Measures

Full Information

First Posted
September 25, 2014
Last Updated
November 27, 2019
Sponsor
University Health Network, Toronto
Collaborators
Ozmosis Research Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02268370
Brief Title
Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Acronym
TRAD
Official Title
Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Ozmosis Research Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dasatinib
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Primary Outcome Measure Information:
Title
Molecular Remission
Time Frame
change from baseline in Molecular Profile at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of CML Treatment of chronic phase CML treated for a minimum of three years exclusively with imatinib Levels of BCR-ABL by RQ-PCR with ≥ 4.5 log reduction from baseline Provide written informed consent Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Age >18 years. Adequate organ liver and renal functions Normal serum levels (within normal limits) Exclusion Criteria: Prior treatment with a TKI (except for imatinib, hydroxyurea, anagrelide or interferon) Taking any medications or substances known to affect CYP3A4. Concurrent medical condition which may increase the risk of toxicity History of significant bleeding disorder unrelated to cancer Cardiac Symptoms Clinically significant hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Kim, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z1M9
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Ottawa General Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus
City
Charlesbourg
State/Province
Quebec
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Treatment-free Remission Accomplished With Dasatinib in Patients With CML

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