Quizartinib for Acute Myeloid Leukemia

Recruiting at 3 trial locations

Overseen By Contact for Trial Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Daiichi Sankyo

Must not be taking: CYP3A inducers

Disqualifiers: APL, BCR-ABL leukemia, cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 87 months

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of blood cancer called FLT3-ITD (+) acute myeloid leukemia who are in their first complete remission. They should have had 1-2 cycles of induction therapy and up to 4 consolidation treatments, but no stem cell transplant. Participants need to start maintenance within 60 days after the last treatment cycle.

Inclusion Criteria

I can use FLT3 inhibitors during my initial or follow-up cancer treatment.

I can start the next treatment phase within 60 days after finishing my last treatment cycle.

My blood counts meet the required levels for neutrophils and platelets.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive quizartinib as maintenance therapy after induction/consolidation

Up to 87 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Quizartinib

Trial Overview The study tests two different doses of Quizartinib as maintenance therapy for AML patients in remission. It's designed to see which dose is more effective at keeping the cancer from returning. Patients will be randomly assigned to receive either a low or high dose.

How Is the Trial Designed?

Group I: Arm 2 Experimental Treatment 1 Intervention

Participants will receive lower dose of quizartinib

Group II: Arm 1 Experimental Treatment 1 Intervention

Participants will receive higher dose of quizartinib

Who Is Running the Clinical Trial?

Daiichi Sankyo

Lead Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD