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gilteritinib for Acute Myeloid Leukemia

Phase 3

Waitlist Available

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 66 months (5.5 years)

Awards & highlights

Study Summary

This trial is testing if a drug called gilteritinib can help people with FLT3/ITD AML stay in remission after a stem cell transplant.

Eligible Conditions

Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 66 months (5.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~66 months (5.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 66 months (5.5 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

Relapse-free survival

Secondary outcome measures

Cumulative Incidence of Acute Graft vs. Host Disease (GVHD)

Cumulative Incidence of Chronic GVHD at 12 months

Cumulative Incidence of Chronic GVHD at 24 months

+7 more

Side effects data

From 2021 Phase 1 & 2 trial • 11 Patients • NCT03730012

100%

Dyspnoea

100%

Muscular weakness

100%

Febrile neutropenia

100%

Decreased appetite

100%

Dizziness

67%

Oedema peripheral

67%

Confusional state

67%

Epistaxis

67%

Delirium

67%

Insomnia

67%

Fatigue

67%

Neck pain

67%

Contusion

67%

Abdominal pain

67%

Constipation

67%

Arthralgia

67%

Weight decreased

67%

Rash maculo-papular

67%

Hypertension

67%

Hypotension

33%

Diarrhoea

33%

Enterococcal infection

33%

Cerebrovascular accident

33%

Device leakage

33%

Malaise

33%

Non-cardiac chest pain

33%

Anxiety

33%

Depression

33%

Hyperuricaemia

33%

Sepsis

33%

Hypertriglyceridaemia

33%

Hypoxia

33%

Rales

33%

Supraventricular extrasystoles

33%

Nodule

33%

Paraesthesia

33%

Ocular icterus

33%

Blood lactate dehydrogenase increased

33%

Dehydration

33%

Hepatitis

33%

Rhinitis allergic

33%

Bacteraemia

33%

Sinus tachycardia

33%

Fall

33%

Chloroma

33%

Tremor

33%

Multiple organ dysfunction syndrome

33%

Arrhythmia supraventricular

33%

Hyperglycaemia

33%

Sinus bradycardia

33%

Head injury

33%

Pyrexia

33%

Localised oedema

33%

Hepatomegaly

33%

Anaemia

33%

Peripheral sensory neuropathy

33%

Pneumonia

33%

Aphasia

33%

Subdural haematoma

33%

Aspartate aminotransferase increased

33%

Dry eye

33%

Dry mouth

33%

Dyspepsia

33%

Flatulence

33%

Oral pain

33%

Paraesthesia oral

33%

Bacterial test positive

33%

Blood alkaline phosphatase increased

33%

Acidosis

33%

Hypoalbuminaemia

33%

Hypomagnesaemia

33%

Hyponatraemia

33%

Back pain

33%

Muscle spasms

33%

Musculoskeletal chest pain

33%

Lethargy

33%

Memory impairment

33%

Haematuria

33%

Pollakiuria

33%

Cough

33%

Nasal congestion

33%

Oropharyngeal pain

33%

Productive cough

33%

Upper-airway cough syndrome

33%

Hyperhidrosis

33%

Infusion related reaction

33%

Squamous cell carcinoma

33%

Endocarditis

33%

Platelet count decreased

33%

Respiratory syncytial virus test positive

33%

Somnolence

33%

Syncope

33%

Skin ulcer

100%

80%

60%

40%

20%

Study treatment Arm

Gilteritinib 120 mg + Atezolizumab 420 mg

Gilteritinib 120 mg + Atezolizumab 840 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GilteritinibExperimental Treatment1 Intervention

Participants will take gilteritinib once daily for continuous daily dosing.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take placebo once daily for continuous daily dosing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

gilteritinib

2016

Completed Phase 3

~430

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Blood and Marrow Transplant Clinical Trials NetworkNETWORK

49 Previous Clinical Trials

13,626 Total Patients Enrolled

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

120,706 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,140 Total Patients Enrolled

Frequently Asked Questions

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

What is the status of gilteritinib's FDA approval process?

"Since gilteritinib is a Phase 3 trial medication, that means there is already some evidence of efficacy and multiple rounds of data supporting safety. Our team ranks the safety of gilteritinib as a 3."

Answered by AI

What is the ceiling for the number of patients who can enroll in this research project?

"As of right now, this study is not actively recruiting patients. However, this could change in the future as the study was last edited on October 26th, 2022. If you're interested in other clinical trials, there are 1586 trials for leukemia, myeloid, acute and 18 trials for gilteritinib that are currently looking for participants."

Answered by AI

What are the previous research findings on gilteritinib?

"There are a total of 18 ongoing clinical trials for gilteritinib.Phase 3 trials are the most advanced type of study, and 5 of the 18 trials for gilteritinib are in this stage. 1002 research sites are running gilteritinib trials around the world, with a concentration of studies in Madison, Wisconsin."

Answered by AI

How many sites are conducting this research?

"There are a total of 53 openings for this study at renowned institutions such as Weill Cornell Medical Center in New york, Dana Farber Cancer Institute in Boston, and Virginia G Piper Cancer Center in Scottsdale."

Answered by AI

Recent research and studies

flt3-Journal

Follow-up of Patients with R/R <i>flt3-</i>mutation–positive AML Treated with Gilteritinib in the Phase 3 ADMIRAL Trial

Perl, Alexander E., Richard A. Larson, Nikolai A. Podoltsev, Stephen Strickland, Eunice S. Wang, Ehab Atallah, Gary J. Schiller, et al.. 2022. “Follow-up of Patients with R/R flt3-mutation–positive AML Treated with Gilteritinib in the Phase 3 ADMIRAL Trial”. Blood. American Society of Hematology. doi:10.1182/blood.2021011583.

clinicaltrials.govStudy

A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)

2017. "A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02997202.