Clinical trial NCT02268370: Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Official title: Treatment-free Remission Accomplished With Dasatinib in Patients With CML
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Ozmosis Research Inc.
First posted: 2014-10-20
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Molecular Remission
timeFrame: change from baseline in Molecular Profile at 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Charlesbourg
country: Canada
facility: Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: University Health Network, Toronto
name: Dennis Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: