Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: 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 ID: NCT03070093
Interventions
Study Description
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.
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. \[Specific to investigational sites in Japan: Study population does not include subjects with FLT3-mutated AML in CRc (CR, CRi, CRp) with MRD. Hence, efficacy (MRD response rate and duration of response) data will not be collected for subjects enrolled in Japan.\]
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA, Los Angeles, California, United States
Rocky Mountain Cancer Center-M, Aurora, Colorado, United States
Memorial Healthcare System, Pembroke Pines, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Northwestern University Medical Center, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Indiana Blood and Marrow Transplantation at Franciscan Health Indianapolis, Indianapolis, Indiana, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Tulane University, New Orleans, Louisiana, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center -Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
West Michigan Regional Cancer Center, Kalamazoo, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest Baptist Hospital, Winston-Salem, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
UPCI, Pittsburgh, Pennsylvania, United States
Vanderbilt University, Nashville, Tennessee, United States
Huntsman Cancer Institute University of Utah, Salt Lake City, Utah, United States
WVU Medicine Cancer, Morgantown, West Virginia, United States
Site CA15002, Halifax, Nova Scotia, Canada
Site CA15003, Toronto, Ontario, Canada
Site CA15001, Montreal, Quebec, Canada
Site CA15005, Vancouver, , Canada
Site JP81001, Nagoya, Aichi, Japan
Site JP81002, Shinagawa-ku, Tokyo, Japan
Site JP81003, Fukuoka, , Japan
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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