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Tyrosine Kinase Inhibitor
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
Participant is eligible for pre-selected salvage chemotherapy
Participant has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification (2008) as determined by pathology review at the treating institute
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until the data cut-off date 04 aug 2017, the 142 patients included in the primary analysis of cr/crh rate were followed up at least 112 days
Awards & highlights
Study Summary
This trial is testing a new cancer drug, ASP2215, to see if it can help people with a certain type of leukemia who have not responded to other treatments. The trial will compare how well the new drug works to standard chemotherapy.
Who is the study for?
This trial is for adults with relapsed or refractory Acute Myeloid Leukemia (AML) that have a specific mutation called FLT3. They should not have had success with first-line AML therapy and must be physically able to handle the treatments, as indicated by an ECOG performance status of 2 or less. Women of childbearing age must agree to use effective contraception and not breastfeed.Check my eligibility
What is being tested?
The study tests ASP2215 against standard salvage chemotherapy in patients whose AML has returned after treatment or didn't respond to initial therapy. It aims to see if ASP2215 can improve overall survival, event-free survival, and rates of complete remission compared to existing chemotherapy options.See study design
What are the potential side effects?
While specific side effects are not listed here, typical ones from leukemia treatments include nausea, fatigue, increased risk of infection due to low blood cell counts, bleeding or bruising easily from low platelets, liver problems shown by blood tests changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a specific follow-up chemotherapy.
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I have been diagnosed with acute myeloid leukemia, either primary or following MDS.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
I am using reliable birth control methods.
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My AML did not respond or has returned after initial treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until the data cut-off date 04 aug 2017, the 142 patients included in the primary analysis of cr/crh rate were followed up at least 112 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until the data cut-off date 04 aug 2017, the 142 patients included in the primary analysis of cr/crh rate were followed up at least 112 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Overall Survival (OS)
Percentage of Participants With Complete Remission and Complete Remission With Partial Hematological Recovery (CR/CRh) in the Gilteritinib Arm
Secondary outcome measures
Fatigue
Duration of Event-Free Survival (EFS)
Leukemia
+7 moreSide effects data
From 2021 Phase 1 & 2 trial • 11 Patients • NCT03730012100%
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%
0%
Study treatment Arm
Gilteritinib 120 mg + Atezolizumab 420 mg
Gilteritinib 120 mg + Atezolizumab 840 mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GilteritinibExperimental Treatment1 Intervention
Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria.
Group II: Salvage ChemotherapyActive Control4 Interventions
Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on MEC chemotherapy received mitoxantrone 8 mg/m^2 daily by IV for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5). Participants on FLAG-IDA chemotherapy received G-CSF 300 μg/m^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gilteritinib
2016
Completed Phase 3
~430
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,691 Total Patients Enrolled
Executive Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
25 Previous Clinical Trials
7,881 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active leukemia in my brain or spinal cord.I have been cancer-free from another type of cancer for at least 5 years.I am eligible for a specific follow-up chemotherapy.My AML developed after chemotherapy for another cancer, not including MDS.My blood cancer has returned after treatment or is not responding to treatment.I have been treated with FLT3 inhibitors before.I have not had major surgery or radiation within the last 4 weeks.I do not have an active infection or liver disease, including HIV or hepatitis B/C.I am currently being treated for GVHD with steroids.My cancer has an FLT3 mutation, but not the excluded types.I have been diagnosed with acute myeloid leukemia, either primary or following MDS.I can take care of myself and am up and about more than half of my waking hours.I can take pills by mouth.I have severe heart failure.I have a known heart condition.I am using reliable birth control methods.My AML did not respond or has returned after initial treatment.I am following the required birth control guidelines due to my potential to conceive.I need to take certain medications along with the trial treatment.I have leukemia that is positive for BCR-ABL.I have been diagnosed with acute promyelocytic leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Salvage Chemotherapy
- Group 2: Gilteritinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical condition is gilteritinib most often used to treat?
"gilteritinib can be used as treatment for multiple sclerosis, merkel cell cancer, and to improve a patient's complete blood count."
Answered by AI
Are patients being accepted into the trial at this time?
"This clinical trial is not recruiting patients at this time. The study was initially posted on 10/20/2015 and was last updated on 11/15/2022. If you are seeking for other studies, there are currently 1591 clinical trials actively enrolling participants with leukemia, myeloid and 1086 studies for gilteritinib actively looking for participants."
Answered by AI
What other gilteritinib-based research has been done in the past?
"There are 1086 ongoing studies that investigate gilteritinib with 190 of those trials in the third and final stage. Most of these clinical trials originate from Leipzig, Sachsen; however, there are 30215 total locations conducting research on gilteritinib."
Answered by AI
What is the gilteritinib success rate in the United States?
"There is some evidence for gilteritinib's efficacy and multiple rounds of data supporting its safety, so it received a score of 3."
Answered by AI
What is the total number of research sites for this clinical trial?
"Right now, this clinical trial is enrolling patients at 41 locations, which are situated in Detroit, Boston, Minneapolis and other nearby areas. To limit the amount of travel required, it would be best to select the location nearest you."
Answered by AI
How many individuals will be participating in this research project?
"This clinical trial is not presently seeking participants anymore. The trial was initially posted on 10/20/2015 and was most recently updated on 11/15/2022. If you are looking for other studies, there are presently 1591 trials actively looking for patients with leukemia, myeloid and 1086 studies for gilteritinib actively looking for participants."
Answered by AI
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