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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,520 Previous Clinical Trials
503,113 Total Patients Enrolled
32 Trials studying Leukemia
9,306 Patients Enrolled for Leukemia
Ozmosis Research Inc.Industry Sponsor
23 Previous Clinical Trials
4,995 Total Patients Enrolled
3 Trials studying Leukemia
113 Patients Enrolled for Leukemia
Dennis Kim, MDPrincipal InvestigatorUniversity Health Network, Toronto
6 Previous Clinical Trials
880 Total Patients Enrolled
~12 spots leftby Nov 2025