Treatment-free Remission Accomplished With Dasatinib in Patients With CML

NCT02268370 | Unknown Phase 2

• 2 other identifiers: BMS CA180-543OZM-056
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 12

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.

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Molecular Remission

  change from baseline in Molecular Profile at 12 months

Study Arms (1)

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.

Drug: Dasatinib

Interventions

Dasatinib DRUG

Also known as: Sprycel

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Ozmosis Research Inc.: collaborator

Study Sites (12)

Tom Baker Cancer Center

Calgary, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z1M9, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Centre Hôpitallier Universitaire de Quebec - Hôpital de l'Enfant-Jésus

Charlesbourg, Quebec, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Dennis Kim, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2021
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

CA (12)