Spots Global Cancer Trial Database for A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
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Trial Identification
Brief Title: A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
Official Title: A Phase 3 Open-Label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
Study ID: NCT02421939
Conditions
Study Description
Brief Summary: The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Detailed Description: Participants considered an adult according to local regulations at the time of signing informed consent may participate in this study. Participants will be randomized in a 2:1 ratio to receive ASP2215 or salvage chemotherapy. Participants will enter the screening period up to 14 days prior to the start of treatment. Prior to randomization, a salvage chemotherapy regimen will be pre-selected for each participant; options will include low-dose cytarabine (LoDAC), azacitidine, mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC), or fludarabine, cytarabine, and granulocyte colony-stimulating factor (G-CSF) with idarubicin (FLAG-IDA). The randomization will be stratified by response to first-line therapy and pre-selected salvage chemotherapy. Participants will be administered treatment over continuous 28-day cycles. After treatment discontinuation, participants will have a pre-hematopoietic stem cell transplant (HSCT)/end-of-treatment visit within 7 days after treatment discontinuation, followed by a 30-day follow-up for safety, in which a telephone contact with the participant is sufficient unless any assessment must be repeated for resolution of treatment-related adverse events (AEs). After that, long term follow-up will be done every 3 months up to 3 years from the participant's end-of-treatment visit.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site US10011, Birmingham, Alabama, United States
Site US10012, Los Angeles, California, United States
Site US10076, Orange, California, United States
Site US10073, San Francisco, California, United States
Site US10067, New Haven, Connecticut, United States
Site US10045, Gainesville, Florida, United States
Site US10081, Atlanta, Georgia, United States
Site US10006, Chicago, Illinois, United States
Site US10075, Westwood, Kansas, United States
Site US10074, Louisville, Kentucky, United States
Site US10048, New Orleans, Louisiana, United States
Site US10005, Baltimore, Maryland, United States
Site US10034, Boston, Massachusetts, United States
Site US10022, Boston, Massachusetts, United States
Site US10085, Boston, Massachusetts, United States
Site US10087, Detroit, Michigan, United States
Site US10057, Minneapolis, Minnesota, United States
Site US10023, Lebanon, New Hampshire, United States
Site US10027, Hackensack, New Jersey, United States
Site US10077, New Brunswick, New Jersey, United States
Site US10001, Buffalo, New York, United States
Site US10037, New York, New York, United States
Site US10008, New York, New York, United States
Site US10013, New York, New York, United States
Site US10072, New York, New York, United States
Site US10046, Syracuse, New York, United States
Site US10024, Durham, North Carolina, United States
Site US10078, Winston-Salem, North Carolina, United States
Site US10044, Cleveland, Ohio, United States
Site US10084, Columbus, Ohio, United States
Site US10058, Oklahoma City, Oklahoma, United States
Site US10041, Hershey, Pennsylvania, United States
Site US10010, Philadelphia, Pennsylvania, United States
Site US10080, Philadelphia, Pennsylvania, United States
Site US10014, Charleston, South Carolina, United States
Site US10063, Nashville, Tennessee, United States
Site US10035, Milwaukee, Wisconsin, United States
Site BE32002, Yvoir, , Belgium
Site CA15004, Edmonton, Alberta, Canada
Site CA15001, Hamilton, Ontario, Canada
Site CA15015, Toronto, Ontario, Canada
Site CA15003, Montreal, Quebec, Canada
Site FR33013, Brest, , France
Site FR33002, Le Chesnay Cedex, , France
Site FR33010, Lille, , France
Site FR33009, Pessac, , France
Site FR33014, Rennes, , France
Site FR33008, Toulouse, , France
Site DE49009, Dresden, , Germany
Site DE49011, Leipzig, , Germany
Site DE49003, Marburg, , Germany
Site DE49002, Munchen, , Germany
Site DE49010, Tubingen, , Germany
Site IL97201, Ashkelon, , Israel
Site IL97209, Haifa, , Israel
Site IL97203, Jerusalem, , Israel
Site IL97210, Jerusalem, , Israel
Site IL97206, Petah Tikva, , Israel
Site IL97208, Rehovot, , Israel
Site IT39005, Bologna, , Italy
Site IT39010, Brescia, , Italy
Site IT39001, Milan, , Italy
Site IT39004, Palermo, , Italy
Site IT39011, Pavia, , Italy
Site IT39007, Roma, , Italy
Site IT39002, Varese, , Italy
Site JP81002, Nagoya, Aichi, Japan
Site JP81010, Narita, Chiba, Japan
Site JP81026, Yoshida-gun, Fukui, Japan
Site JP81016, Sapporo, Hokkaido, Japan
Site JP81018, Kobe, Hyogo, Japan
Site JP81017, Tsukuba, Ibaraki, Japan
Site JP81009, Isehara, Kanagawa, Japan
Site JP81006, Yokohama, Kanagawa, Japan
Site JP81012, Sendai, Miyagi, Japan
Site JP81007, Kurashiki, Okayama, Japan
Site JP81014, Osakasayama, Osaka, Japan
Site JP81020, Kawagoe, Saitama, Japan
Site JP81027, Shimotsuke, Tochigi, Japan
Site JP81005, Chuo-ku, Tokyo, Japan
Site JP81004, Shinagawa-ku, Tokyo, Japan
Site JP81022, Shinjuku-ku, Tokyo, Japan
Site JP81023, Akita, , Japan
Site JP81021, Aomori, , Japan
Site JP81013, Kumamoto, , Japan
Site JP81025, Kyoto, , Japan
Site JP81008, Nagasaki, , Japan
Site JP81024, Okayama, , Japan
Site JP81011, Osaka, , Japan
Site KR82005, Suwon-si, Gyeonggi-do, Korea, Republic of
Site KR82010, Busan, , Korea, Republic of
Site KR82009, Goyang, , Korea, Republic of
Site KR82003, Jeollanam-do, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
Site KR82002, Seoul, , Korea, Republic of
Site KR82008, Seoul, , Korea, Republic of
Site KR82011, Seoul, , Korea, Republic of
Site PL48002, Gdansk, , Poland
Site PL48005, Opole, , Poland
Site PL48004, Wroclaw, , Poland
Site ES34009, Badalona, , Spain
Site ES34011, Barcelona, , Spain
Site ES34012, Barcelona, , Spain
Site ES34010, Barcelona, , Spain
Site ES34016, Girona, , Spain
Site ES34005, L'Hospitalet de Llobregat, , Spain
Site ES34014, Salamanca, , Spain
Site ES34017, Valencia, , Spain
Site TW88606, Kaohsiung, , Taiwan
Site TW88604, Kaohsiung, , Taiwan
Site TW88609, Taichung City, , Taiwan
Site TW88608, Taichung, , Taiwan
Site TW88601, Tainan, , Taiwan
Site TW88603, Taipei, , Taiwan
Site TW88610, Taipei, , Taiwan
Site TW88611, Taipei, , Taiwan
Site TW88602, Taipei, , Taiwan
Site TW88605, Taoyuan, , Taiwan
Site TR90001, Ankara, , Turkey
Site TR90004, Ankara, , Turkey
Site GB44014, Bournemouth, , United Kingdom
Site GB44013, Harrow, , United Kingdom
Site GB44003, Manchester, , United Kingdom
Site GB44015, Plymouth, , United Kingdom
Contact Details
Name: Executive Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR
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