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Gilteritinib Maintenance Therapy for Acute Myeloid Leukemia

Phase 2
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
Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min/1.73m^2 as calculated with the 4-parameter Modification of Diet in Renal Disease (MDRD) equation.
Male subject and subject's female partners who are of childbearing potential must be using highly effective contraception per locally accepted standards (in addition to a barrier method) starting at screening and continue throughout the study period and for 4 months and 1 week after the final study drug administration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 2, 3, 4, 5, 6, 8, 10. 12, 14, 16, 18, 20, 22 and 24/eot
Awards & highlights

Study Summary

This trial found that gilteritinib improved RFS in patients with FLT3/ITD AML in CR1.

Who is the study for?
Adults with FLT3/ITD acute myeloid leukemia in first complete remission, who have completed chemotherapy and are not proceeding with a bone marrow transplant. Participants must be able to take oral medication, have good organ function, agree to use effective contraception, and not be involved in other interventional studies.Check my eligibility
What is being tested?
The trial is testing Gilteritinib as maintenance therapy against a placebo in patients with FLT3/ITD AML after they've achieved their first complete remission post-chemotherapy. The goal is to compare how long each group stays cancer-free without relapse over two years.See study design
What are the potential side effects?
Gilteritinib may cause side effects such as changes in liver enzymes, issues with heart rhythm (QT prolongation), gastrointestinal symptoms like nausea or diarrhea, blood cell count abnormalities which can lead to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is within the required range.
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I am using effective birth control methods, as required, during and after the study.
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I will not donate eggs during and for 6 months after the study.
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My AML is in its first complete remission without signs of leukemia outside the bone marrow.
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My leukemia has the FLT3/ITD mutation.
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I can take care of myself and am up and about more than half of my waking hours.
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I have not had a menstrual period for at least one year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 2, 3, 4, 5, 6, 8, 10. 12, 14, 16, 18, 20, 22 and 24/eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 2, 3, 4, 5, 6, 8, 10. 12, 14, 16, 18, 20, 22 and 24/eot 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 (RFS) Per Independent Review Committee (IRC) Adjudication
Secondary outcome measures
Change From Baseline in Quantitative Minimal Residual Disease Measured as Log10-transformed Overall FLT3/ITD Mutation Ratio at Months 3, 6, 12, 24/End of Treatment (EoT)
Event-Free Survival (EFS)
Number of Participants With Adverse Events (AE)
+2 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%
0%
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
Placebo Group
Group I: GilteritinibExperimental Treatment1 Intervention
Participants received gilteritinib 120 mg (three tablets of 40 mg) orally, once daily (QD) for up to 2 years or until a protocol-specified discontinuation criterion was met.
Group II: PlaceboPlacebo Group1 Intervention
Participants received gilteritinib matching placebo orally, QD for up to 2 years or until a protocol-specified discontinuation criterion was met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gilteritinib
2014
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
195 Previous Clinical Trials
121,399 Total Patients Enrolled
Executive Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
25 Previous Clinical Trials
8,154 Total Patients Enrolled

Media Library

Gilteritinib Clinical Trial Eligibility Overview. Trial Name: NCT02927262 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Placebo, Gilteritinib
Acute Myeloid Leukemia Clinical Trial 2023: Gilteritinib Highlights & Side Effects. Trial Name: NCT02927262 — Phase 2
Gilteritinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT02927262 — Phase 2

Frequently Asked Questions

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

How many different medical sites are currently engaged in this trial?

"Patients can join this clinical trial at Site US10030 in Jacksonville, Nova Scotia, CA15001 in Halifax, South carolina and US10029 in Greenville Illinois. Additionally, there are 8 other sites recruiting participants."

Answered by AI

What potential harms could result from taking gilteritinib?

"Our team has assigned a safety rating of 2 to gilteritinib, as this Phase 2 trial provides some evidence for its security but does not have data backing up its efficacy."

Answered by AI

Have other researchers conducted investigations into gilteritinib?

"Currently, 17 medical studies are taking place to explore the efficacy of gilteritinib. Of those investigations, 6 of them have progressed to Phase 3 trials. While Madison, Wisconsin is the epicentre for these scientific inquiries, there are 1045 separate sites participating in this research internationally."

Answered by AI

Are there any slots available for enrollment in this research project?

"The details available on clinicaltrials.gov signify that this study is not currently accepting new participants, given it was first posted in January 10th 2017 and last updated November 15th 2022. Although the trial has closed its recruitment period, there are 1,551 other trials actively looking for volunteers."

Answered by AI

What is the ceiling for participants in this research endeavor?

"This study is no longer recruiting participants and was last amended on November 15, 2022. Fortunately, there are 1,534 studies actively searching for leukemia patients as well 17 trials that utilize gilteritinib in search of suitable candidates."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
2017. "A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02927262.
~12 spots leftby May 2025
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