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)
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)
1 other identifier
expanded_access
N/A
3 countries
39
Brief Summary
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.
Trial Health
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39 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedApril 20, 2021
April 1, 2021
February 28, 2017
April 18, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- +13 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
UCLA
Los Angeles, California, 90095, United States
Rocky Mountain Cancer Center-M
Aurora, Colorado, 80012, United States
Memorial Healthcare System
Pembroke Pines, Florida, 33028, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Northwestern University Medical Center
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana Blood and Marrow Transplantation at Franciscan Health Indianapolis
Indianapolis, Indiana, 45237, United States
Norton Cancer Institute
Louisville, Kentucky, 40207, United States
Tulane University
New Orleans, Louisiana, 70112, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
The Sidney Kimmel Comprehensive Cancer Center -Johns Hopkins University
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
West Michigan Regional Cancer Center
Kalamazoo, Michigan, 49007, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157, United States
Ohio State University
Columbus, Ohio, 43210, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19066, United States
UPCI
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, 84112, United States
WVU Medicine Cancer
Morgantown, West Virginia, 26506, United States
Site CA15002
Halifax, Nova Scotia, Canada
Site CA15003
Toronto, Ontario, Canada
Site CA15001
Montreal, Quebec, H1T 2M4, Canada
Site CA15005
Vancouver, Canada
Site JP81001
Nagoya, Aichi-ken, Japan
Site JP81002
Shinagawa-ku, Tokyo, Japan
Site JP81003
Fukuoka, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Astellas Pharma Global Development, Inc.