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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 below

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My kidney, liver, and heart are functioning well.

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My cancer returned after one high-dose chemo treatment, but I haven't tried more than once to achieve remission.

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I have been diagnosed with AML with at least 5% blasts in my bone marrow.

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My cancer has the FLT3-ITD mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active hepatitis B or C.

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I have a known history of HIV.

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I do not have significant heart disease that is not under control.

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I am not on any cancer treatments not listed in the study guidelines.

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I have a specific type of leukemia or a related condition.

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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

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