- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070093
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)
Study Overview
Status
Intervention / Treatment
Detailed Description
The United States Food and Drug Administration (FDA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and Health Canada have approved ASP2215/Gilteritinib (XOSPATA®) for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
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.]
Study Type
Expanded Access Type
- Treatment IND/Protocol
Contacts and Locations
Study Locations
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Vancouver, Canada
- Site CA15005
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Site CA15002
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Ontario
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Toronto, Ontario, Canada
- Site CA15003
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Quebec
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Montreal, Quebec, Canada, H1T 2M4
- Site CA15001
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Fukuoka, Japan
- Site JP81003
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Aichi
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Nagoya, Aichi, Japan
- Site JP81001
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Tokyo
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Shinagawa-ku, Tokyo, Japan
- Site JP81002
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California
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Los Angeles, California, United States, 90095
- UCLA
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Center-M
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Florida
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Pembroke Pines, Florida, United States, 33028
- Memorial Healthcare System
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Georgia
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Atlanta, Georgia, United States, 30342
- Northside Hospital
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Augusta, Georgia, United States, 30912
- Georgia Cancer Center at Augusta University
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Chicago, Illinois, United States, 60611
- Northwestern University Medical Center
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Indiana
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Indianapolis, Indiana, United States, 45237
- Indiana Blood and Marrow Transplantation at Franciscan Health Indianapolis
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Kentucky
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Louisville, Kentucky, United States, 40207
- Norton Cancer Institute
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane University
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Center
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Baltimore, Maryland, United States, 21287
- The Sidney Kimmel Comprehensive Cancer Center -Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02215
- Dana Farber Cancer Institute
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Michigan
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Kalamazoo, Michigan, United States, 49007
- West Michigan Regional Cancer Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- New Mexico Cancer Care Alliance
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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New York, New York, United States, 10065
- Weill Cornell Medical College
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New York, New York, United States, 10021
- Memorial Sloan Kettering
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Hospital
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University
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Oregon
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Portland, Oregon, United States, 97213
- Providence Portland Medical Center
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
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Philadelphia, Pennsylvania, United States, 19066
- Thomas Jefferson University
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Pittsburgh, Pennsylvania, United States, 15232
- UPCI
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute University of Utah
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West Virginia
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Morgantown, West Virginia, United States, 26506
- WVU Medicine Cancer
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Study Director: Medical Director, Astellas Pharma Global Development, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease Attributes
- Hematologic Diseases
- Neoplastic Processes
- Disease Progression
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Neoplasm, Residual
- Pathologic Complete Response
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Tyrosine Kinase Inhibitors
- Gilteritinib
Other Study ID Numbers
- 2215-CL-9100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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