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Nucleoside Metabolic Inhibitor
Gilteritinib + Azacitidine 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
Subject is positive for FLT3 mutation in bone marrow or whole blood as determined by central laboratory
Subject has a diagnosis of previously-untreated AML according to World Health Organization (WHO) classification as determined by pathology review at the treating institution
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 77 months
Awards & highlights
Study Summary
This trial is testing an experimental drug, ASP2215 (gilteritinib), on patients recently diagnosed with AML. AML is cancer of the bone marrow where abnormal white blood cells are produced. The trial will compare the effects of ASP2215 with the standard of care treatment, azacitidine (Vidaza®), on patients' overall survival.
Who is the study for?
Adults recently diagnosed with AML and a FLT3 gene mutation, who can't have standard chemo. They must be over 18 (or over 65 in some cases), not suitable for intensive chemotherapy due to age or health issues like heart failure, poor kidney function, or low performance status. Participants need functioning major organs and agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
The trial is testing gilteritinib alone or combined with azacitidine versus azacitidine by itself in adults with AML who can't receive standard chemo. Gilteritinib targets the FLT3 protein to slow leukemia growth. Patients are randomly assigned to treatments, with a higher chance of receiving the combination therapy.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, changes in liver enzymes, gastrointestinal symptoms like nausea and vomiting, blood cell count abnormalities which could lead to infections or bleeding problems, fatigue, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood or bone marrow tested positive for the FLT3 mutation.
Select...
I have been diagnosed with AML for the first time.
Select...
I am not eligible for intensive chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 77 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 77 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Best response
Complete remission (CR) rate
Complete remission and complete remission with partial hematological recovery (CR/CRh) rate
+14 moreSide effects data
From 2022 Phase 3 trial • 730 Patients • NCT0341617956%
Nausea
51%
Anaemia
49%
Febrile neutropenia
48%
Diarrhoea
42%
Pyrexia
39%
Platelet count decreased
38%
Hypokalaemia
36%
Constipation
32%
White blood cell count decreased
29%
Vomiting
28%
Neutrophil count decreased
26%
Thrombocytopenia
26%
Decreased appetite
23%
Rash
21%
Neutropenia
21%
Hypophosphataemia
20%
Alanine aminotransferase increased
20%
Dysgeusia
20%
Headache
16%
Fatigue
16%
Abdominal pain
16%
Pneumonia
16%
Hypoalbuminaemia
15%
Stomatitis
15%
Hypomagnesaemia
15%
Aspartate aminotransferase increased
14%
Insomnia
13%
Oedema peripheral
13%
Hypocalcaemia
13%
Blood bilirubin increased
12%
Dizziness
12%
Cough
12%
Hyponatraemia
11%
Electrocardiogram QT prolonged
11%
Alopecia
11%
Weight decreased
11%
Back pain
11%
Rash maculo-papular
10%
Epistaxis
10%
Muscle spasms
10%
Lymphocyte count decreased
10%
Oropharyngeal pain
10%
Chills
9%
Arthralgia
9%
Hypotension
9%
Blood creatinine increased
8%
Bacteraemia
8%
Dyspnoea
8%
Asthenia
8%
Myalgia
8%
Sepsis
7%
Blood alkaline phosphatase increased
7%
Haemorrhoids
7%
Proctalgia
7%
Hyperuricaemia
7%
Non-cardiac chest pain
7%
Dry skin
6%
Sinus tachycardia
6%
Pruritus
6%
Gamma-glutamyltransferase increased
6%
Abdominal pain upper
6%
Dyspepsia
6%
Mucosal inflammation
6%
Paraesthesia
5%
Oedema
5%
Leukopenia
5%
Upper respiratory tract infection
5%
Hyperglycaemia
5%
Hypertension
4%
Petechiae
3%
Urinary tract infection
2%
Gastrointestinal haemorrhage
2%
Atrial fibrillation
2%
Infection
2%
Pseudomonal bacteraemia
1%
Disease progression
1%
Septic shock
1%
Soft tissue infection
1%
Pneumonia fungal
1%
Groin abscess
1%
Neutropenic sepsis
1%
Leukocytosis
1%
Peritonitis
1%
Fungal infection
1%
Haemorrhage intracranial
1%
Malaise
1%
Graft versus host disease in gastrointestinal tract
1%
Hypoxia
1%
Cardiac arrest
1%
Cardiac failure acute
1%
Myocarditis
1%
Lower gastrointestinal haemorrhage
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Escherichia bacteraemia
1%
Pseudomembranous colitis
1%
Fall
1%
Syncope
1%
Acute kidney injury
1%
Acute myocardial infarction
1%
Anal fistula
1%
Enterocolitis
1%
Gastric ulcer
1%
Intussusception
1%
Small intestinal haemorrhage
1%
Cholelithiasis
1%
Graft versus host disease in skin
1%
Clostridium colitis
1%
Pulmonary tuberculosis
1%
Urethritis
1%
Cerebral haemorrhage
1%
Adjustment disorder with depressed mood
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Erythema
1%
Orthostatic hypotension
1%
Enterococcal bacteraemia
1%
Splenic necrosis
1%
Upper gastrointestinal haemorrhage
1%
Escherichia sepsis
1%
Herpes ophthalmic
1%
Pulmonary haemorrhage
1%
Clostridial sepsis
1%
Hyperbilirubinaemia
1%
Arthritis infective
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intensive Study: Glasdegib + Cytarabine + Daunorubicin
Intensive Study: Placebo + Cytarabine + Daunorubicin
Non-intensive Study: Glasdegib + Azacitidine
Non-intensive Study: Placebo + Azacitidine
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Dose escalation of ASP2215 given with azacitidineExperimental Treatment2 Interventions
Subjects will be treated with ASP2215 daily (days 1-28) and azacitidine daily for 7 days (days 1-7).
Group II: Arm AC: ASP2215 + azacitidineExperimental Treatment2 Interventions
Subjects will be treated with ASP2215 daily and azacitidine daily for 7 days (days 1-7) each 28-day cycle.
Group III: Arm A: ASP2215Experimental Treatment1 Intervention
Subjects will be treated daily each 28-day cycle.
Group IV: Arm C: azacitidineActive Control1 Intervention
Subjects will be treated with azacitidine for 7 days (days 1-7) each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
gilteritinib
2016
Completed Phase 3
~430
azacitidine
2005
Completed Phase 3
~1740
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,879 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,297 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need to take certain medications along with my treatment.I am legally an adult where I live.My blood or bone marrow tested positive for the FLT3 mutation.I am not pregnant, agree to use contraception, am not breastfeeding, and won't donate eggs.I agree to use contraception since my partner can become pregnant.I am being treated for another cancer besides the one being studied.I have active hepatitis B, C, or another liver condition.I am between 65 and 74 years old and open to starting strong chemotherapy.I can take pills by mouth.I have been diagnosed with acute promyelocytic leukemia.My leukemia is BCR-ABL positive.My leukemia is affecting my brain or spinal cord.I have a history of Long QT Syndrome.I have been diagnosed with AML for the first time.I have had treatment for AML, with some exceptions.I have severe heart failure.I am not eligible for intensive chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation of ASP2215 given with azacitidine
- Group 2: Arm A: ASP2215
- Group 3: Arm AC: ASP2215 + azacitidine
- Group 4: Arm C: azacitidine
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 are the chances that azacitidine will help patients?
"Azacitidine is considered safe based on its Phase 3 status. This indicates that, while there is still some testing required, there is data supporting both efficacy and safety."
Answered by AI
How many people are investigators testing in this clinical trial?
"This study is no longer recruiting patients. However, when it was active, the clinical trial was posted on 8/1/2016 and last updated on 9/15/2022. If you are interested in other studies, there are currently 1586 trials actively searching for patients with leukemia and myeloid and 192 studies for azacitidine that are enrolling participants."
Answered by AI
At how many locations is this research being conducted?
"At the moment, this clinical trial is recruiting patients from 16 sites. The locations are situated in Chicago, Greenville, Montreal, and 16 other places. If you enroll in the trial, it would be helpful to choose the site that is closest to you to minimize travel demands."
Answered by AI
Could you please provide a history of azacitidine clinical trials?
"At the current moment, there are a total of 192 different clinical trials underway that are studying azacitidine. Out of those, 36 are classified as Phase 3 trials. Many of the trials for azacitidine are based in Saint Louis, but there are actually 6407 total locations running trials for this medication."
Answered by AI
What is azacitidine used to treat?
"azacitidine is most often used to regulate a patient's complete blood count. It can also be used as part of induction chemotherapy, to treat refractory anemias, and in the case of acute myelocytic leukemia."
Answered by AI
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