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Tyrosine Kinase Inhibitor

Vyxeos + Gilteritinib for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By Onyee Chan, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

FLT3 testing must be confirmed at the time of disease relapse

Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs for people with a certain type of leukemia. The drugs will be given as induction therapy, and those patients entering remission will be able to proceed to consolidation therapy. Those not proceeding to stem cell transplant will be able to enter maintenance phase using one of the drugs.

Who is the study for?

This trial is for adults with a specific mutation in their leukemia cells (FLT3) who have seen their disease return or not respond to treatment. They must be able to perform daily activities with some limitations, take oral meds, and use effective birth control if applicable. People can't join if they've had certain complications like severe graft versus host disease after a stem cell transplant or AML progression on gilteritinib.Check my eligibility

What is being tested?

The study tests combining Vyxeos (chemotherapy) and Gilteritinib (targeted therapy) in patients whose acute myeloid leukemia has returned or resisted treatment. It involves initial intense therapy followed by maintenance using Gilteritinib alone for those ineligible for stem cell transplant.See study design

What are the potential side effects?

Possible side effects include heart problems due to Vyxeos, gastrointestinal issues affecting how well the body absorbs Gilteritinib, liver and kidney function changes, blood count abnormalities leading to increased infection risk, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My FLT3 test was positive at the time my disease came back.

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

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My AML has FLT3 mutations and has not responded to at least one treatment.

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I have received a limited amount of a specific chemotherapy drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD)

Secondary outcome measures

Complete Remission Rate

Event free survival (EFS)

Overall survival (OS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Expansion ArmExperimental Treatment2 Interventions

Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy in the dose determined in the dose escalation arm.

Group II: Dose Escalation ArmExperimental Treatment2 Interventions

Participants will receive intravenous Vyxeos on days 1, 3 and 5 and Gilteritinib will be given on days 6-19 of induction therapy. The induction and reinduction dose of Vyxeos is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. Dose level 1: Vyxeos + 120 mg Gilertinib In the event of a dose-limiting toxicity (DLT) at the initial dose level, a dose level minus (-) 1 is permitted Dose Level -1: Vyxeos + 80 mg Gilertinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gilteritinib

2014

Completed Phase 2

~560

0 / 4Eligibility criteria met