Chronic Myeloid LeukemiaPhase 2TRADNCT02268370
Treatment-free Remission Accomplished With Dasatinib in Patients With CML
A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia, run by University Health Network, Toronto at 12 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 12 sitesCanada
- Study dates
- Oct 2014to Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Tom Baker Cancer Center
Calgary, Alberta
Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus
Charlesbourg, Quebec
University of Alberta Hospital
Edmonton, Alberta
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Juravinski Cancer Centre
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
Hopital Maisonneuve-Rosemont
Montreal, Quebec
McGill University Health Centre
Montreal, Quebec
Ottawa General Hospital
Ottawa, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
Cancer Care Manitoba
Winnipeg, Manitoba
About this study
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.
Read the 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.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Dasatinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Also called Sprycel
| Study group | Role | What they receive |
|---|---|---|
| Dasatinib | Other | 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. Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular Remission
Measured: change from baseline in Molecular Profile at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ozmosis Research Inc.
- Responsible party
- Sponsor
- Investigators
- Dennis Kim, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02268370
- Sponsor's protocol ID
- BMS CA180-543
- Other IDs
- OZM-056
- Acronym
- TRAD
- Status last verified
- Nov 2019
- First submitted
- 25 Sep 2014
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment-free Remission Accomplished With Dasatinib in Patients With CML
- ClinicalTrials.gov ID
- NCT02268370
- Acronym / sponsor ID
- TRAD / BMS CA180-543
- Conditions
- Chronic Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ozmosis Research Inc.
- Study start
- Oct 2014
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dasatinib | Other | Drug: DasatinibThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DasatinibAlso: Sprycel | Drug | Dasatinib |
Primary outcome
Molecular Remission
Time frame: change from baseline in Molecular Profile at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Kim, MD principal investigator
University Health Network, Toronto
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib in people with Chronic Myeloid Leukemia, run by University Health Network, Toronto at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular Remission (time frame: change from baseline in Molecular Profile at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.