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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

Must not have

Participant has clinically active central nervous system leukemia

Participant has been diagnosed with another malignancy, unless disease-free for at least 5 years

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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.

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I am using reliable birth control methods.

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My AML did not respond or has returned after initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active leukemia in my brain or spinal cord.

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I have been cancer-free from another type of cancer for at least 5 years.

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My AML developed after chemotherapy for another cancer, not including MDS.

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My blood cancer has returned after treatment or is not responding to treatment.

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I have been treated with FLT3 inhibitors before.

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I have not had major surgery or radiation within the last 4 weeks.

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I have severe heart failure.

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I have a known heart condition.

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I do not have an active infection or liver disease, including HIV or hepatitis B/C.

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I am currently being treated for GVHD with steroids.

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My cancer has an FLT3 mutation, but not the excluded types.

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I need to take certain medications along with the trial treatment.

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I have leukemia that is positive for BCR-ABL.

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I have been diagnosed with acute promyelocytic leukemia.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Fatigue

Duration of Event-Free Survival (EFS)

Leukemia

+7 more

Side effects data

From 2023 Phase 3 trial • 356 Patients • NCT02997202

53%

Chronic graft versus host disease

38%

Acute graft versus host disease

28%

Neutrophil count decreased

25%

Diarrhoea

21%

Nausea

19%

Alanine aminotransferase increased

19%

Cough

19%

Blood creatine phosphokinase increased

18%

Platelet count decreased

17%

Anaemia

17%

Fatigue

16%

Aspartate aminotransferase increased

16%

Oedema peripheral

16%

Hypertension

13%

Vomiting

13%

Neutropenia

13%

Dizziness

12%

Upper respiratory tract infection

12%

Dry mouth

12%

Thrombocytopenia

12%

White blood cell count decreased

11%

Headache

11%

Dry eye

11%

Constipation

10%

Dyspnoea

10%

Viral upper respiratory tract infection

10%

Myalgia

10%

Blood creatinine increased

10%

Hypokalaemia

Pyrexia

Pneumonia

Back pain

Arthralgia

Dry skin

Blood alkaline phosphatase increased

Pain in extremity

Insomnia

Hypomagnesaemia

Hyperglycaemia

Muscle spasms

Pruritus

Rash maculo-papular

Oropharyngeal pain

Anxiety

Non-cardiac chest pain

Influenza

Rash

Abdominal pain

Decreased appetite

Peripheral sensory neuropathy

Hyperkalaemia

Blood lactate dehydrogenase increased

Neuropathy peripheral

Paraesthesia

Hypophosphataemia

Cytomegalovirus viraemia

Febrile neutropenia

Acute kidney injury

Respiratory syncytial virus infection

Lower respiratory tract infection

Viral sepsis

Rhinorrhoea

Escherichia sepsis

Urinary tract infection bacterial

Medication error

Sepsis

Femoral neck fracture

Escherichia urinary tract infection

Eye infection

Graft versus host disease

Muscular weakness

Motor neurone disease

Device related infection

Lower respiratory tract infection bacterial

Colitis ulcerative

Lacunar stroke

Renal impairment

Pericardial effusion

Hepatic enzyme increased

Bronchopulmonary aspergillosis allergic

Bacteraemia

Stress fracture

COVID-19

Appendicitis

Arthritis infective

Pneumonia bacterial

Viral haemorrhagic cystitis

Psychotic disorder

Phimosis

Electrocardiogram QT prolonged

Myelitis transverse

Somatic symptom disorder

Clostridial sepsis

Klebsiella sepsis

Atrial fibrillation

Cystitis haemorrhagic

Epstein-Barr viraemia

Agranulocytosis

Death

Clostridium difficile colitis

Adenovirus infection

Neutropenic sepsis

Pharyngeal abscess

Skin cancer

Interstitial lung disease

Herpes zoster

Accidental overdose

Fall

Femur fracture

Oropharyngeal squamous cell carcinoma

Pneumothorax

Gastroenteritis norovirus

Gastrointestinal infection

Respiratory tract infection viral

Graft versus host disease in lung

Deep vein thrombosis

Cytomegalovirus colitis

Cytopenia

Post transplant lymphoproliferative disorder

Encephalopathy

Genital infection bacterial

Prinzmetal angina

Pneumonia fungal

Pneumocystis jirovecii pneumonia

Febrile bone marrow aplasia

Antithrombin III deficiency

Cystitis bacterial

Suicidal ideation

Respiratory failure

Hepatic function abnormal

Liver disorder

Oesophageal infection

Septic shock

Hyponatraemia

Syncope

Hypoxia

Adrenal insufficiency

Deafness neurosensory

Duodenal ulcer haemorrhage

Ophthalmic herpes zoster

Cerebral haemorrhage

Embolism

Clostridium difficile infection

Cytomegalovirus enterocolitis

Enterobacter sepsis

Enterococcal sepsis

Lower respiratory tract infection fungal

Lower respiratory tract infection viral

Pseudomonal sepsis

Viraemia

Bowen's disease

Gastroenteritis

Squamous cell carcinoma of skin

Streptococcal bacteraemia

Colitis

Fluid overload

Pseudomonas infection

Hip fracture

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Gilteritinib

Awards & Highlights

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.

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

0 / 19Eligibility criteria met