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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
Must not have
Subject requires treatment with specific concomitant drugs
Subject has been diagnosed with another malignancy that requires concurrent treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 77 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

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.
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.
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 below
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My blood or bone marrow tested positive for the FLT3 mutation.
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I have been diagnosed with AML for the first time.
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I am not eligible for intensive chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need to take certain medications along with my treatment.
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I am being treated for another cancer besides the one being studied.
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I have active hepatitis B, C, or another liver condition.
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I am between 65 and 74 years old and open to starting strong chemotherapy.
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I have been diagnosed with acute promyelocytic leukemia.
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My leukemia is BCR-ABL positive.
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My leukemia is affecting my brain or spinal cord.
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I have a history of Long QT Syndrome.
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I have severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 77 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 77 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS)
Secondary study objectives
Best response
Complete remission (CR) rate
Complete remission and complete remission with partial hematological recovery (CR/CRh) rate
+11 more

Side effects data

From 2022 Phase 3 trial • 730 Patients • NCT03416179
56%
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%
Abdominal pain
16%
Fatigue
16%
Pneumonia
16%
Hypoalbuminaemia
15%
Aspartate aminotransferase increased
15%
Hypomagnesaemia
15%
Stomatitis
14%
Insomnia
13%
Oedema peripheral
13%
Hypocalcaemia
13%
Blood bilirubin increased
12%
Hyponatraemia
12%
Dizziness
12%
Cough
11%
Electrocardiogram QT prolonged
11%
Weight decreased
11%
Back pain
11%
Alopecia
11%
Rash maculo-papular
10%
Oropharyngeal pain
10%
Muscle spasms
10%
Epistaxis
10%
Chills
10%
Lymphocyte count decreased
9%
Arthralgia
9%
Hypotension
9%
Blood creatinine increased
8%
Myalgia
8%
Sepsis
8%
Asthenia
8%
Dyspnoea
8%
Bacteraemia
7%
Haemorrhoids
7%
Proctalgia
7%
Non-cardiac chest pain
7%
Blood alkaline phosphatase increased
7%
Hyperuricaemia
7%
Dry skin
6%
Paraesthesia
6%
Gamma-glutamyltransferase increased
6%
Pruritus
6%
Sinus tachycardia
6%
Abdominal pain upper
6%
Dyspepsia
6%
Mucosal inflammation
5%
Leukopenia
5%
Upper respiratory tract infection
5%
Hyperglycaemia
5%
Oedema
5%
Hypertension
4%
Petechiae
3%
Urinary tract infection
2%
Infection
2%
Gastrointestinal haemorrhage
2%
Atrial fibrillation
2%
Pseudomonal bacteraemia
1%
Fungal infection
1%
Upper gastrointestinal haemorrhage
1%
Cardiac arrest
1%
Lower gastrointestinal haemorrhage
1%
Cardiac failure acute
1%
Myocarditis
1%
Arthritis infective
1%
Disease progression
1%
Hyperbilirubinaemia
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Escherichia bacteraemia
1%
Neutropenic sepsis
1%
Pneumonia fungal
1%
Pseudomembranous colitis
1%
Septic shock
1%
Soft tissue infection
1%
Fall
1%
Haemorrhage intracranial
1%
Syncope
1%
Acute kidney injury
1%
Leukocytosis
1%
Splenic necrosis
1%
Acute myocardial infarction
1%
Anal fistula
1%
Enterocolitis
1%
Gastric ulcer
1%
Intussusception
1%
Small intestinal haemorrhage
1%
Malaise
1%
Cholelithiasis
1%
Graft versus host disease in gastrointestinal tract
1%
Graft versus host disease in skin
1%
Clostridial sepsis
1%
Clostridium colitis
1%
Enterococcal bacteraemia
1%
Escherichia sepsis
1%
Groin abscess
1%
Herpes ophthalmic
1%
Peritonitis
1%
Pulmonary tuberculosis
1%
Urethritis
1%
Cerebral haemorrhage
1%
Adjustment disorder with depressed mood
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Hypoxia
1%
Pulmonary haemorrhage
1%
Erythema
1%
Orthostatic hypotension
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Non-intensive Study: Placebo + Azacitidine
Intensive Study: Glasdegib + Cytarabine + Daunorubicin
Intensive Study: Placebo + Cytarabine + Daunorubicin
Non-intensive Study: Glasdegib + Azacitidine

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~1730

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,368 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,883 Previous Clinical Trials
8,088,502 Total Patients Enrolled

Media Library

Azacitidine (Nucleoside Metabolic Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02752035 — Phase 3
AML Research Study Groups: Dose escalation of ASP2215 given with azacitidine, Arm A: ASP2215, Arm AC: ASP2215 + azacitidine, Arm C: azacitidine
AML Clinical Trial 2023: Azacitidine Highlights & Side Effects. Trial Name: NCT02752035 — Phase 3
Azacitidine (Nucleoside Metabolic Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02752035 — Phase 3
~20 spots leftby Nov 2025
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