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Quizartinib + Chemotherapy for Leukemia (QuANTUM-WILD Trial)

Phase 3

Recruiting

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* ≥18 years or the minimum legal adult age (whichever is greater) and 70 years (at Screening).

* Participant is receiving standard "7+3" induction chemotherapy regimen as specified in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up date of randomization up to approximately 42 months

Awards & highlights

Pivotal Trial

Summary

This trial will look at whether Quizartinib, when used with chemotherapy, is more effective than a placebo in treating a type of acute myeloid leukemia called FLT3-ITD negative AML

Who is the study for?

This trial is for adults aged 18 to 70 with newly diagnosed acute myeloid leukemia (AML) that lacks the FLT3-ITD mutation. Participants should be able to perform daily activities with minimal assistance (ECOG status of 0-2) and must understand and sign a consent form. They should be starting the standard '7+3' induction chemotherapy.

What is being tested?

The study is testing whether adding Quizartinib, an experimental drug, to standard chemotherapy is more effective than adding a placebo in patients with AML who do not have the FLT3-ITD mutation.

What are the potential side effects?

Quizartinib may cause side effects such as nausea, vomiting, diarrhea, QT prolongation (a type of heart rhythm problem), and potential liver toxicity. Chemotherapy can lead to hair loss, fatigue, increased risk of infection due to low blood cell counts, bleeding or bruising easily.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I am currently on a '7+3' chemotherapy regimen.

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I have been newly diagnosed with a type of leukemia called AML.

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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ date of randomization up to approximately 42 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~date of randomization up to approximately 42 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and date of randomization up to approximately 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (Arm A vs Arm B)

Secondary study objectives

Complete remission rate (Arm A vs. Arm B)

Complete remission rate with minimal or measurable residual disease (Arm A vs. Arm B)

Duration of complete response (Arm A vs. Arm B)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm C: Quizartinib + Chemotherapy then Placebo MaintenanceExperimental Treatment3 Interventions

Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Group II: Arm A: Quizartinib + ChemotherapyExperimental Treatment2 Interventions

Participants will receive quizartinib at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Group III: Arm B: Placebo + ChemotherapyPlacebo Group2 Interventions

Participants will receive placebo at 60 mg/day orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo at 60 mg/day orally once daily for up to 36 cycles (28-day cycle)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quizartinib

2016

Completed Phase 3

~1130

Placebo

1995

Completed Phase 3

~2670