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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ on day 56 (± 3 days) for the last subject, within 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 56 (± 3 days) for the last subject, within 4 years
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active hepatitis B or C.I am between 1 month and 21 years old.My kidney, liver, and heart are functioning well.I have a known history of HIV.I do not have significant heart disease that is not under control.You have had a bad reaction or allergy to any of the study medications.I am not on any cancer treatments not listed in the study guidelines.I have a specific type of leukemia or a related condition.I understand the study's risks and benefits and have signed the consent form.I have recovered from side effects of my previous cancer treatments.My cancer returned after one high-dose chemo treatment, but I haven't tried more than once to achieve remission.I am a man who is either surgically sterile or will use effective birth control during and for 6 months after treatment.I have been diagnosed with AML with at least 5% blasts in my bone marrow.I don't have an ongoing infection, or if I did, it's improving with treatment.My cancer has the FLT3-ITD mutation.
Research Study Groups:
This trial has the following groups:- Group 1: All Participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.