A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 1, 2016
End Date:December 2021
Contact:Astellas Pharma Global Development
Email:astellas.registration@astellas.com
Phone:800-888-7704

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A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy

This is a clinical study for adult patients who have recently been diagnosed with acute
myeloid leukemia or AML. AML is a type of cancer. It is when bone marrow makes white blood
cells that are not normal. These are called leukemia cells. Some patients with AML have a
mutation, or change, in the FLT3 gene. This gene helps leukemia cells make a protein called
FLT3. This protein causes the leukemia cells to grow faster.

For patients with AML who cannot receive standard chemotherapy, azacitidine (also known as
Vidaza®) is a current standard of care treatment option in the United States. This clinical
study is testing an experimental medicine called ASP2215, also known as gilteritinib.
Gilteritinib works by stopping the leukemia cells from making the FLT3 protein. This can help
stop the leukemia cells from growing faster.

This study will compare two different treatments. Patients are assigned to one of these two
groups by chance: a medicine called azacitidine, also known as Vidaza®, or an experimental
medicine gilteritinib in combination with azacitidine. There is a twice as much chance to
receive both medicines combined than azacitidine alone. The clinical study may help show
which treatment helps patients live longer.

Patients considered an adult according to local regulation at the time of obtaining informed
consent may participate in the study.

Safety Cohort Prior to initiation of the randomized trial, 8 to 12 patients will be enrolled
to evaluate the safety and tolerability of ASP2215 given with azacitidine therapy in the
study population.

Randomized Trial Approximately 323 patients will be randomized in a 2:1 ratio to receive
ASP2215 plus azacitidine (Arm AC) or azacitidine only (Arm C).

Earlier protocol versions included a 1:1:1 randomization ratio to receive Arm A: ASP2215, Arm
AC: ASP2215 + azacitidine or Arm C: azacitidine. Randomization to Arm A was removed in the
current protocol version. Patients previously randomized to Arm A should continue following
treatment and assessments as outlined in the protocol.

Patients will enter the screening period up to 14 days prior to the start of treatment.
Patients will be administered treatment over 28-day cycles.

Inclusion Criteria:

- Subject is considered an adult according to local regulation at the time of obtaining
informed consent.

- Subject has a diagnosis of previously-untreated AML according to World Health
Organization (WHO) classification [Swerdlow et al, 2008] as determined by pathology
review at the treating institution.

- Subject is positive for FLT3 mutation (internal tandem duplication [ITD] or tyrosine
kinase domain [TKD] [D835/I836] mutation) (or for Korea only: ITD alone or ITD with
concurrent TKD activating mutation) in bone marrow or whole blood as determined by
central laboratory. Note: Only applicable to the randomization portion.

- Subject is ineligible for intensive induction chemotherapy by meeting at least 1 of
the following criteria:

1. Subject is ≥ 75 years of age.

2. Subject has any of the following comorbidities:

- Congestive heart failure (New York Heart Association {NYHA} class ≤ 3) or
ejection fraction (Ef) ≤ 50%;

- Creatinine > 2 mg/dL (177 µmol/L), dialysis or prior renal transplant;

- ECOG performance status ≥ 2;

- Known pulmonary disease with decreased diffusion capacity of lung for carbon
monoxide (DLCO) and/or requiring oxygen ≤ 2 liters per minute

- Prior or current malignancy that does not require concurrent treatment;

- Subject has received a cumulative anthracycline dose above 400 mg/m2 of
doxorubicin (or cumulative maximum dose of another anthracycline).

- Subject must meet the following criteria as indicated on the clinical laboratory
tests:

- Serum AST and ALT ≤ 2.5 x Institutional upper limit of normal (ULN)

- Serum total bilirubin ≤ 1.5 x Institutional ULN

- Serum potassium ≥ Institutional lower limit of normal (LLN)

- Serum magnesium ≥ Institutional LLN

- Subject is suitable for oral administration of study drug.

- Female subject is eligible to participate if female subject is not pregnant and at
least one of the following conditions applies:

- Not a woman of childbearing potential (WOCBP); OR

- WOCBP agrees to follow the contraceptive guidance starting at screening and
continue throughout the study period, and for at least 180 days after the final
study drug administration.

- Female subject must agree not to breastfeed starting at screening and throughout the
study period, and for 60 days after the final study drug administration.

- Female subject must not donate ova starting at screening and throughout the study
period, and for 180 days after the final study drug administration.

- Male subject with female partners of childbearing potential must agree to use
contraception as detailed in Contraception Requirements, starting at screening and
continue throughout the study period, and for 120 days after the final study drug
administration.

- Male subject must not donate sperm starting at screening and throughout the study
period and for 120 days after the final study drug administration.

- Subject agrees not to participate in another interventional study while on treatment.

Exclusion Criteria:

- Subject was diagnosed as acute promyelocytic leukemia (APL).

- Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).

- Subject has received previous therapy for AML, with the exception of the following:

- Emergency leukapheresis

- Hydroxyurea

- Preemptive treatment with retinoic acid prior to exclusion of APL ≤ 7 days

- Growth factor or cytokine support

- Steroids

- Subject has clinically active central nervous system leukemia.

- Subject has been diagnosed with another malignancy that requires concurrent treatment
(with the exception of hormone therapy) or hepatic malignancy regardless of need for
treatment.

- Subject has clinically significant coagulation abnormality unless secondary to AML.

- Subject has had major surgery within 4 weeks prior to the first study dose.

- Subject has radiation therapy within 4 weeks prior to the first study dose.

- Subject requires treatment with concomitant drugs that are strong inducers of
cytochrome P450 CYP3A.

- Subject requires treatment with concomitant drugs that are strong inhibitors or
inducers of P-gp with the exception of drugs that are considered absolutely essential
for the care of the subject.

- Subject requires treatment with concomitant drugs that target serotonin
5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the
exception of drugs that are considered absolutely essential for the care of the
subject.

- Subject has congestive heart failure classified as New York Heart Association Class
IV.

- Subject with mean Fridericia-corrected QT interval (QTcF) > 450 ms at screening based
on central reading.

- Subject with a history of Long QT Syndrome at screening.

- Subject has known pulmonary disease with diffusion capacity of lung for carbon
monoxide (DLCO) ≤ 50%, forced expiratory volume in the first second (FEV1) ≤ 60%,
dyspnea at rest or requiring oxygen or any pleural neoplasm (Transient use of
supplemental oxygen is allowed.)

- Subject has an active uncontrolled infection. If an infection is present, the patient
must be receiving definitive therapy and have no signs of progressing infection.
Progressing infection is defined as hemodynamic instability attributable to sepsis or
new symptoms, worsening physical signs or radiographic findings attributable to
infection. Persisting fever without other signs or symptoms will not be interpreted as
progressing infection.

- Subject is known to have human immunodeficiency virus infection.

- Subject has active hepatitis B or C or other active hepatic disorder.

- Subject has any condition which makes the subject unsuitable for study participation,
including any contraindications of azacitidine.
We found this trial at
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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7777 Forest Ln # C840
Dallas, Texas 75230
(972) 566-7000
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Los Angeles, California 90033
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University of Southern California The University of Southern California is one of the world’s leading...
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1410 Laney Walker Boulevard
Augusta, Georgia 30912
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Camperdown, New South Wales 2038
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Greenville, South Carolina 29615
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Hershey, Pennsylvania 17033
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
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Los Angeles, California 90095
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Louisville, Kentucky 40207
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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Morristown, New Jersey 07960
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35 Park Street
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1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
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10 Union Square East
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1275 York Ave
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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940 NE 13th St
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101 The City Drive South
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Orlando, Florida 32806
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