Quizartinib for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+32 other locations

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Daiichi Sankyo

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.

Eligibility Criteria

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.

Inclusion Criteria

I am between 1 month and 21 years old.

My kidney, liver, and heart are functioning well.

If of reproductive potential, is permanently sterile or agrees to use highly effective birth control upon enrollment, during the period of therapy, and for 6 months following the last dose of quizartinib, etoposide, fludarabine, methotrexate, or cytarabine, whichever is later

+8 more

Exclusion Criteria

I do not have active hepatitis B or C.

Is currently participating in another investigative interventional procedure (observational or long-term interventional follow-up is allowed)

I have a known history of HIV.

+7 more

Participant Groups

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.

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.

Quizartinib is already approved in United States, Japan for the following indications:

🇺🇸 Approved in United States as Vanflyta for: