Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)



Status:Available
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Contact:Astellas Pharma Global Development
Email:astellas.registration@astellas.com
Phone:800-888-7704

Use our guide to learn which trials are right for you!

A Multicenter, Open-label Treatment Protocol of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

The purpose of this study is to provide expanded access to ASP2215 for subjects with
FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission
(CRc) (complete remission [CR], complete remission with incomplete hematologic recovery
[CRi], complete remission with incomplete platelet recovery [CRp]) with MRD without access to
comparable or alternative therapy.

The United States Food and Drug Administration (FDA) and the Japanese Ministry of Health,
Labour and Welfare (MHLW) has approved ASP2215/Gilteritinib (XOSPATA®) for the treatment of
adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3
mutation. Enrollment is closed in the United States and Japan.

This treatment protocol is being conducted while phase 3 ASP2215 studies are ongoing in
FLT3-mutated AML subjects.

Subjects will complete visits on cycle 1 - days 1, 4, 8, 15; cycle 2 - days 1, 15; cycles 3
to 6 - day 1; and day 1 of every 2 cycles thereafter (i.e., cycle 8 day 1, cycle 10 day 1,
etc.) until discontinued from the study.

Subjects will be provided with study medication until the investigator determines the subject
is no longer receiving clinical benefit.

An end of treatment visit will be performed within 7 days after last dose of investigational
product (ASP2215), or prior to initiation of another anticancer therapy, whichever occurs
earlier, followed by a 30-day follow-up. [Specific to investigational sites in Japan: Study
population does not include subjects with FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD.
Hence, efficacy (MRD response rate and duration of response) data will not be collected for
subjects enrolled in Japan.]

Inclusion Criteria:

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

- Subject has a diagnosis of primary AML or AML secondary to myelodysplastic syndrome
(MDS) or therapy-related AML according to World Health Organization (WHO)
classification.

- Subject has presence of the FLT3-mutated relapsed or refractory AML or FLT3-mutated
AML in CRc (CR, CRi, CRp) with MRD in bone marrow or peripheral blood. [Specific to
investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD
subjects will not be included.]

- Subject has refractory or relapsed AML (with or without hematopoietic stem cell
transplant [HSCT]) or AML in CRc (CR, CRi, CRp) with MRD by flow cytometry or genetic
testing for the FLT3 mutation after induction/consolidation regimen or HSCT. [Specific
to investigational sites in Japan: FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD
subjects will not be included.]

- Subject must wait for at least 5 half-lives after stopping therapy with any
investigational agent and before starting ASP2215.

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

- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x
institutional upper limit of normal (ULN)

- Serum total bilirubin ≤ 2.5 mg/dL, except for subjects with Gilbert's syndrome

- Serum potassium and serum magnesium ≥ institutional lower limit of normal (LLN).

- Subject is able to tolerate oral administration of study drug.

- Subject who has developed overall grades II-IV acute graft-versus-host disease (GVHD)
must satisfy the following criteria:

- No requirement of > 0.5 mg/kg of prednisone (or equivalent) daily dose within 1
week of enrollment

- No escalation of immunosuppression in terms of increase of corticosteroids or
addition of new agent/modality in prior 2 weeks (note that increasing calcineurin
inhibitors or sirolimus to achieve therapeutic trough levels is allowed)

- Female subject must either:

- Be of nonchildbearing potential:

- Postmenopausal (defined as at least 1 year without any menses) prior to
screening, or

- Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy,
bilateral oophorectomy) at least 1 month prior to screening.

- Or, if of childbearing potential,

- Agree not to try to become pregnant during the study and for at least 180 days
after the final study drug administration

- And have a negative urine pregnancy test at screening

- And, if heterosexually active, agree to use consistently 2 forms of effective
contraception per locally accepted standards (1 of which must be a barrier
method) starting at screening and throughout the study period and for at least
180 days after the final study drug administration.

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

- Male subject (even if surgically sterilized) and partners who are women of
childbearing potential must agree to practice 2 forms of effective contraception per
locally accepted standards

(1 of which must be a barrier method), starting at screening and 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 for AML while on
treatment.

- Subject who has a diagnosis of HIV may be enrolled as long as the disease is under
control on antiretroviral therapy. Precautions should be taken to modify highly active
antiretroviral therapy (HAART) regimen to minimize drug interactions.

- There is no comparable or satisfactory alternative therapy to treat the subject's AML.

Exclusion Criteria:

- Subject is eligible to participate in an ongoing clinical study of ASP2215; or has
previously participated in a randomized clinical study of ASP2215 with a primary
endpoint of overall survival that is not closed for efficacy.

- Subject with QTcF > 450 ms at screening based on local reading.

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

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

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

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

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

- Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias,
electrocardiographic evidence of acute ischemia, or New York Heart Association (NYHA)
Class IV heart failure.

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

- Subject has any condition which makes the subject unsuitable for study participation.

- Subject has hypersensitivity to any of the study drug components.
We found this trial at
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New Orleans, Louisiana 70112
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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666 Elm Street
Buffalo, New York 14263
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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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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Albuquerque, New Mexico 87109
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Aurora, Colorado 80012
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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Chicago, Illinois 60611
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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Halifax, Nova Scotia
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Hershey, Pennsylvania 17033
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200 North Park Street
Kalamazoo, Michigan 49007
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Los Angeles, California 90095
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Louisville, Kentucky 40207
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1 Medical Center Drive
Morgantown, West Virginia 26506
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
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New York, New York 10065
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New York, New York 10021
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Pembroke Pines, Florida 33028
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1020 Walnut St
Philadelphia, Pennsylvania 19107
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Pittsburgh, Pennsylvania 15232
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660 S Euclid Ave
Saint Louis, Missouri 63110
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
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Winston-Salem, North Carolina 27157
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