← Back to Search

Tyrosine Kinase Inhibitor

Quizartinib for Acute Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Daiichi Sankyo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has protocol-defined adequate renal, hepatic and cardiac functions
In first relapse or refractory to first-line high-dose chemotherapy with no more than 1 attempt (1 to 2 cycles of induction chemotherapy) at remission induction - prior HSCT is permitted
Must not have
Has known active clinically relevant liver disease (e.g., active hepatitis B or active hepatitis C)
Has known history of human immunodeficiency virus (HIV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 56 (± 3 days) for the last subject, within 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for an experimental drug and is only for children or young adults with FLT3-ITD AML that has come back or is not responding to treatment.

Who is the study for?
This trial is for children and young adults aged 1 month to 21 years with a specific blood cancer (FLT3-ITD AML) that's returned or isn't responding to treatment. They must have tried no more than one remission induction, be in good health otherwise, and agree to use effective birth control.
What is being tested?
The study tests Quizartinib, an experimental drug not yet approved for regular use, alongside other chemotherapy drugs like Fludarabine and Cytarabine. It targets patients whose leukemia has relapsed or is resistant to initial treatments.
What are the potential side effects?
Potential side effects may include reactions related to the immune system, issues affecting organs such as kidneys or liver due to toxicity of the drugs, fatigue from chemotherapy, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney, liver, and heart are functioning well.
Select...
My cancer returned after one high-dose chemo treatment, but I haven't tried more than once to achieve remission.
Select...
I have been diagnosed with AML with at least 5% blasts in my bone marrow.
Select...
My cancer has the FLT3-ITD mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have active hepatitis B or C.
Select...
I have a known history of HIV.
Select...
I do not have significant heart disease that is not under control.
Select...
I am not on any cancer treatments not listed in the study guidelines.
Select...
I have a specific type of leukemia or a related condition.
Select...
I don't have an ongoing infection, or if I did, it's improving with treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 56 (± 3 days) for the last subject, within 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 56 (± 3 days) for the last subject, within 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite complete remission (CRc) rate among participants with acute myeloid leukemia (AML) (Phase 1 and 2)
Secondary study objectives
Acceptability of including the palatability of quizartinib formulations among participants with AML (Phase 1 and 2)
Complete remission (CR) rate after completion of re-induction Cycle 1 among participants with AML (Phase 1 and 2)
Complete remission (CR) rate among participants with AML (Phase 1 and 2)
+12 more

Awards & Highlights

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: All ParticipantsExperimental Treatment5 Interventions
All participants will receive re-induction therapy that includes fludarabine and cytarabine in combination with experimental drug quizartinib. For prophylaxis, IT chemotherapy with cytarabine, methotrexate and prednisolone/hydrocortisone will be given prior to or between re-induction cycles. After completing re-induction therapy, eligible participants may also receive optional consolidation chemotherapy which includes cytarabine, etoposide and quizartinib, if HSCT is not available immediately. After completing re-induction or HSCT successfully, eligible participants can go on to receive continuation therapy with quizartinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Quizartinib
2016
Completed Phase 3
~1100
Cytarabine
2016
Completed Phase 3
~3330
Etoposide
2010
Completed Phase 3
~2960

Find a Location

Who is running the clinical trial?

Children's Oncology GroupNETWORK
460 Previous Clinical Trials
239,933 Total Patients Enrolled
Daiichi SankyoLead Sponsor
418 Previous Clinical Trials
468,502 Total Patients Enrolled
Innovative Therapies For Children with Cancer ConsortiumOTHER
13 Previous Clinical Trials
2,031 Total Patients Enrolled
Daiichi Sankyo, Inc.Lead Sponsor
389 Previous Clinical Trials
422,855 Total Patients Enrolled
Global Clinical LeaderStudy DirectorDaiichi Sankyo
163 Previous Clinical Trials
81,367 Total Patients Enrolled

Media Library

Quizartinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03793478 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: All Participants
Acute Myeloid Leukemia Clinical Trial 2023: Quizartinib Highlights & Side Effects. Trial Name: NCT03793478 — Phase 1 & 2
Quizartinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03793478 — Phase 1 & 2
~17 spots leftby May 2027