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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

Study 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.Check my eligibility

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.See study design

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

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

Primary outcome measures

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

Secondary outcome measures

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%

Anaemia

40%

Nausea

20%

Blood thyroid stimulating hormone increased

20%

Leukocytosis

20%

Bacteraemia

20%

Hypothyroidism

20%

Constipation

20%

Abdominal pain

20%

Asthenia

20%

Generalised oedema

20%

Hypokalaemia

20%

Bone pain

20%

Platelet count decreased

20%

Neutrophil count decreased

20%

Cough

20%

Lethargy

20%

Presyncope

20%

Hot flush

20%

Hyperglycaemia

20%

Lip infection

20%

Acute myeloid leukaemia

20%

Vitreous detachment

20%

Vitreous floaters

20%

Oral pain

20%

Vomiting

20%

Fatigue

20%

Memory impairment

20%

Infusion related reaction

20%

Hypomagnesaemia

20%

Tremor

20%

Dry skin

20%

Haemorrhage intracranial

20%

Ear pain

20%

Vision blurred

20%

Proctalgia

20%

Blood alkaline phosphatase increased

20%

Hypophosphataemia

20%

Dysaesthesia

20%

Urinary incontinence

20%

Febrile neutropenia

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 120 mg in Escalation Phase

Gilterinib 200 mg in Escalation Phase

Gilterinib 300 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 200 mg in Expansion Phase

Gilterinib 300 mg in Expansion Phase

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

Cytarabine

2016

Completed Phase 3

~3310

Daunorubicin

2013

Completed Phase 4

~4940

Gilteritinib

2014

Completed Phase 2

~560

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

PrECOG, LLC.Lead Sponsor

17 Previous Clinical Trials

7,277 Total Patients Enrolled

Astellas Pharma IncIndustry Sponsor

692 Previous Clinical Trials

232,238 Total Patients Enrolled

Selena Luger, MDStudy ChairUniversity of Pennsylvania

Media Library

Cytarabine (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03836209 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Arm A, Arm B

Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT03836209 — Phase 2

Cytarabine (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03836209 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this experiment?

"This study has concluded its recruitment efforts as of November 17th 2022. If you are searching for other trials, there exist 1532 active studies with acute leukemia and myelocytic cancer and 273 clinical trials utilizing gilteritinib actively recruiting patients."

Answered by AI

How many institutes are administering this research endeavor?

"This medical trial is enrolling at a total of 44 sites, with some in Los Angeles, Orange and Boston. To reduce the burden of travelling for participants, it may be prudent to select the closest clinic location when considering enrollment."

Answered by AI

Are there any potential safety hazards associated with Gilteritinib treatment?

"With a score of 2, Gilteritinib is thought to be moderately safe as there are some studies that support its safety but none verifying its efficacy."

Answered by AI

May elderly individuals aged 70 and above take part in this scientific experiment?

"The age parameter for this medical examination is 18 to 70 years old."

Answered by AI

What is the current cohort size of this research study?

"Unfortunately, this research trial is no longer seeking participants. The study was initially posted on December 6th 2019 and underwent its last edit November 17th 2022. For those still searching for trials to join, there are presently 1532 studies actively recruiting patients with leukemia or myelocytic acute conditions, as well as 273 clinical trials concerning Gilteritinib that need applicants."

Answered by AI

To what maladies has Gilteritinib been prescribed as a remedy?

"Gilteritinib is an efficacious medication for treating meningeal leukemia, as well other forms of the disease such as acute myelocytic leukemia and lymphoma."

Answered by AI

Are there any other prior experiments that have assessed the efficacy of Gilteritinib?

"As of now, 68 Gilteritinib trials have reached Phase 3 with a total of 273 clinical studies in progress. While the majority are located in New york City, there exists 12991 sites across the world that are conducting research on this medication."

Answered by AI

What are the eligibility requirements for participation in this trial?

"This medical trial seeks 181 participants afflicted with acute myelocytic leukemia aged between 18 and 70. Candidates must satisfy the following essential criteria: sign a Prescreening Consent for centralized testing of bone marrow/peripheral blood, have untreated FLT3 mutated Non M3 AML, commence standard of care induction 7+3 chemotherapy using same regimen and doses as defined in protocol while awaiting prescreening test results, not have received hypomethylating agent within 21 days prior to enrollment or exhibit known active Central Nervous System (CNS) leukemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

2019. "Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03836209.

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