Treatment-free Remission Accomplished With Dasatinib in Patients With CML

Chronic Myeloid Leukemia Clinical Trial

— TRAD  

Official title:

Treatment-free Remission Accomplished With Dasatinib in Patients With CML

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02268370
• Other study ID #: BMS CA180-543
• Secondary ID: OZM-056
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: October 2021

Study information

• Verified date: November 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: October 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Drug:
• Dasatinib

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Ozmosis Research Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular Remission		change from baseline in Molecular Profile at 12 months