Treatment-free Remission Accomplished With Dasatinib in Patients With CML (TRAD)
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| ClinicalTrials.gov Identifier: NCT02268370 |
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Recruitment Status : Unknown
Verified November 2019 by University Health Network, Toronto.
Recruitment status was: Active, not recruiting
First Posted : October 20, 2014
Last Update Posted : November 29, 2019
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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) |
| Actual Enrollment : | 131 participants |
| Allocation: | N/A |
| 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 |
|---|---|
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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 Name: Sprycel |
- Molecular Remission [ Time Frame: change from baseline in Molecular Profile at 12 months ]
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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:
- 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
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
| Canada, Alberta | |
| Tom Baker Cancer Center | |
| Calgary, Alberta, Canada | |
| University of Alberta Hospital | |
| Edmonton, Alberta, Canada | |
| Canada, British Columbia | |
| Vancouver General Hospital | |
| Vancouver, British Columbia, Canada, V5Z1M9 | |
| Canada, Manitoba | |
| Cancer Care Manitoba | |
| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | |
| Halifax, Nova Scotia, Canada | |
| Canada, Ontario | |
| Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada | |
| London Health Sciences Centre | |
| London, Ontario, Canada | |
| Ottawa General Hospital | |
| Ottawa, Ontario, Canada | |
| Princess Margaret Cancer Centre | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada, Quebec | |
| Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus | |
| Charlesbourg, Quebec, Canada | |
| Hopital Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada | |
| McGill University Health Centre | |
| Montreal, Quebec, Canada | |
| Principal Investigator: | Dennis Kim, MD | University Health Network, Toronto |
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT02268370 |
| 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: | November 29, 2019 |
| Last Verified: | November 2019 |
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Dasatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |