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Tyrosine Kinase Inhibitor

Dasatinib for Leukemia (TRAD Trial)

Phase 2
Waitlist Available
Led By Dennis Kim, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline in molecular profile at 12 months
Awards & highlights

TRAD 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.

Eligible Conditions
  • Leukemia

TRAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline in molecular profile at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline in molecular profile at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Molecular Remission

Side effects data

From 2022 Phase 2 trial • 54 Patients • NCT03023046
26%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Atrial fibrillation
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Myocardial infarction
2%
Typhlitis
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)

TRAD Trial Design

1Treatment groups
Experimental Treatment
Group I: DasatinibExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,049 Total Patients Enrolled
31 Trials studying Leukemia
9,224 Patients Enrolled for Leukemia
Ozmosis Research Inc.Industry Sponsor
20 Previous Clinical Trials
4,884 Total Patients Enrolled
2 Trials studying Leukemia
33 Patients Enrolled for Leukemia
Dennis Kim, MDPrincipal InvestigatorUniversity Health Network, Toronto
5 Previous Clinical Trials
780 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~12 spots leftby May 2025