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Chemotherapy Agent

Gilteritinib vs Midostaurin for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Research Sponsored by PrECOG, LLC.

Eligibility Criteria Checklist

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

Must have

Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.

Patient must have adequate organ function as measured by the following criteria, obtained ≤ 48 hours prior to randomization except ECG and left ventricular ejection fraction (LVEF) which can be done ≤ 2 weeks prior to randomization: Serum creatinine ≤ 1.5x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) >40 mL/min as measured by Cockcroft-Gault formula. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3x ULN, unless secondary to leukemia. Serum total or direct bilirubin <2 mg/dL, unless due to Gilbert's, hemolysis or leukemic infiltration. Fridericia-Corrected QT Interval (QTcF) interval ≤ 500 msec (using Fridericia's correction). Left Ventricular Ejection Fraction >45%. The patient may not be known to have hypokalemia and/or hypomagnesemia that does not respond to supplementation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 68 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two drugs, gilteritinib and midostaurin, in patients with FLT3 acute myeloid leukemia who are also receiving standard chemotherapy.

Who is the study for?

Adults aged 18-70 with previously untreated FLT3 mutated Acute Myeloid Leukemia (AML) who have good organ function and no severe heart conditions or other cancers. They must not be pregnant, agree to use contraception, and can't have had certain treatments for related diseases within the last 21 days.

What is being tested?

The trial is testing whether gilteritinib or midostaurin is more effective when combined with standard chemotherapy drugs daunorubicin and cytarabine in treating AML. Gilteritinib is investigational in this context while midostaurin is FDA-approved for FLT3 AML.

What are the potential side effects?

Possible side effects include nausea, vomiting, diarrhea, liver problems, skin reactions, heart issues like irregular heartbeat or chest pain. There's also a risk of infection due to low blood cell counts caused by chemotherapy.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may not be able to do heavy physical work.

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My organ functions are within the required range for the trial.

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I have received treatment for MDS or MPN before.

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My AML is FLT3 mutated and I haven't received treatment for it.

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I don't have GI issues that affect my ability to take pills.

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I am between 18 and 70 years old.

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My leukemia is not classified as M3.

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I haven't had major surgery or radiation therapy in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 68 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~68 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 68 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

FLT3 Mutation Negative Composite Complete Response (CRc) [includes Complete Response (CR) or CR with incomplete hematologic recovery (CRi)] at end of Induction

Secondary study objectives

CRc (CR or CRi) rate at end of Induction

Event Free Survival (EFS)

FLT3 mutation negative Complete Response (CR) rate at end of Induction

+4 more

Side effects data

From 2018 Phase 1 & 2 trial • 265 Patients • NCT02014558

40%

Nausea

40%

Anaemia

20%

Leukocytosis

20%

Generalised oedema

20%

Memory impairment

20%

Constipation

20%

Hyperglycaemia

20%

Ear pain

20%

Lethargy

20%

Abdominal pain

20%

Vision blurred

20%

Hot flush

20%

Acute myeloid leukaemia

20%

Haemorrhage intracranial

20%

Bacteraemia

20%

Febrile neutropenia

20%

Hypothyroidism

20%

Vitreous detachment

20%

Vitreous floaters

20%

Oral pain

20%

Proctalgia

20%

Vomiting

20%

Asthenia

20%

Fatigue

20%

Lip infection

20%

Infusion related reaction

20%

Blood alkaline phosphatase increased

20%

Blood thyroid stimulating hormone increased

20%

Neutrophil count decreased

20%

Platelet count decreased

20%

Hypokalaemia

20%

Hypomagnesaemia

20%

Hypophosphataemia

20%

Bone pain

20%

Dysaesthesia

20%

Presyncope

20%

Tremor

20%

Urinary incontinence

20%

Cough

20%

Dry skin

100%

80%

60%

40%

20%

Study treatment Arm

Gilterinib 20 mg in Escalation Phase

Gilterinib 40 mg in Escalation Phase

Gilterinib 80 mg in Escalation Phase

Gilterinib 200 mg in Escalation Phase

Gilterinib 300 mg in Escalation Phase

Gilterinib 200 mg in Expansion Phase

Gilterinib 120 mg in Escalation Phase

Gilterinib 450 mg in Escalation Phase

Gilterinib 20 mg in Expansion Phase

Gilterinib 40 mg in Expansion Phase

Gilterinib 80 mg in Expansion Phase

Gilterinib 120 mg in Expansion Phase

Gilterinib 300 mg in Expansion Phase

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm AExperimental Treatment3 Interventions

Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib.

Group II: Arm BActive Control3 Interventions

Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Daunorubicin

2013

Completed Phase 4

~5040

Cytarabine

2016

Completed Phase 3

~3330