Spots Global Cancer Trial Database for Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia
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Trial Identification
Brief Title: Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia
Study ID: NCT02920008
Conditions
Study Description
Brief Summary: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine \[HiDAC\]; mitoxantrone, etoposide, and cytarabine \[MEC\]; or fludarabine, cytarabine, granulocyte colony stimulating factor \[G-CSF\], +/- idarubicin \[FLAG/FLAG-Ida\]). * Low intensity (low dose cytarabine \[LDAC\], decitabine, or azacitidine). * BSC.
Detailed Description: This Phase 3, randomized, open-label, parallel-group multicenter study of the efficacy and safety of guadecitabine in adults with previously treated acute myeloid leukemia (AML) will be conducted in approximately 20 countries. There will be a 14-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last approximately 2 years. Duration of individual participant participation will vary, and participants may continue to receive treatment for as long as they continue to benefit. Approximately 404 participants from approximately 100 study centers will be randomly assigned to either guadecitabine or treatment choice (TC) in a 1:1 ratio (approximately 202 participants per group). TC is as follows: * High intensity: intermediate or high dose cytarabine (HiDAC); mitoxantrone, etoposide, and cytarabine (MEC); or fludarabine, cytarabine, G-CSF, +/- idarubicin (FLAG/FLAG-Ida). * Low intensity: low dose cytarabine (LDAC), decitabine, or azacitidine. * Best Supportive Care (BSC). Guadecitabine will be given subcutaneous (SC) at a dose of 60 microgram per meter square (mg/m\^2) in 28-day cycles. In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. Cycle 2 will be either the 5-day regimen (Days 1-5) or 10-day regimen (Days 1-5 and 8-12) based on assessment of disease response and hematologic recovery at the end of Cycle 1. In subsequent cycles, guadecitabine treatment will be for 5 days only (Days 1-5).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Southern California, Los Angeles, California, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Franciscan Research Center, Indianapolis, Indiana, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
University of New Mexico School of Medicine, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Temple University Hospital, Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Baylor Research Institute, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
West Virginia University Hospitals, Inc., Morgantown, West Virginia, United States
AZ Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Hopital Maisonneuve Rosemont, Montreal, , Canada
Aarhus University Hospital, Aarhus C, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Centre Hospitalier de la Côte Basque, Bayonne, , France
Hôpital de la Conception, Marseille, , France
CHRU Montpellier - Saint Eloi, Montpellier, , France
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Mulhouse, , France
Hôpital Saint-Louis, Paris, , France
CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque, Pessac, , France
Centre Hospitalier Lyon-Sud, Pierre Bénite, , France
Centre Henri Becquerel, Rouen cedex 1, , France
Institut Universitaire du Cancer de Toulouse - Oncopole, Toulouse, , France
Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Marien Hospital Düsseldorf GmbH, Düsseldorf, , Germany
Universitätsklinikum Halle (Saale), Halle, , Germany
Universitätsklinikum Schleswig-Holstein, Kiel, , Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg, Mannheim, , Germany
Klinikum der Universität München, Muenchen, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
SE ÁOK I. sz. Belgyógyászati Klinika, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvar, , Hungary
Pecsi Tudomanyegyetem Klinikai Központ, Pécs, , Hungary
Szegedi Tudományegyetem, Szeged, , Hungary
IRCCS AOU San Martino - IST, Genova, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, , Italy
Ospedale San Raffaele - Milano, Milano, , Italy
A.O.R.N. "A. Cardarelli", Napoli, , Italy
A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia, Udine, , Italy
Akita University Hospital, Akita-shi, , Japan
Chugoku Central Hospital, Fukuyama-Shi, , Japan
Tokai University Hospital, Isehara-shi, , Japan
Saitama Medical Center, Kawagoe-Shi, , Japan
Kobe City Medical Center General Hospital, Kobe-shi, , Japan
Japanese Red Cross Kyoto Daini Hospital, Kyoto-shi, , Japan
University Hospital, Kyoto Prefectural University of Medicine, Kyoto-shi, , Japan
Gunmaken Saiseikai Maebashi Hospital, Maebashi-shi, , Japan
Nagasaki University Hospital, Nagasaki-shi, , Japan
The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki-Shi, , Japan
Kindai University Hospital, Osakasayama-Shi, , Japan
Saga University Hospital, Saga-shi, , Japan
NTT Medical Center Tokyo, Shinagawa-Ku, , Japan
Shizuoka Cancer Center, Shizuoka, , Japan
National Hospital Organization Disaster Medical Center, Tachikawa-Shi, , Japan
Yamagata University Hospital, Yamagata-Shi, , Japan
University of Fukui Hospital, Yoshida-Gun, , Japan
Pusan National University Hospital, Busan, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital (UUH), Ulsan, , Korea, Republic of
Instytut Hematologii i Transfuzjologi, Warszawa, , Poland
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Duran i Reynals, Barcelona, , Spain
Vall d'Hebron Institut d'Oncologia, Barcelona, , Spain
Hospital San Pedro de Alcántara, Cáceres, , Spain
Hospital Universitario Reina Sofía, Córdoba, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitario Dr. Peset, Valencia, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Sahlgrenska University Hospital, Göteborg, , Sweden
Khmelnytskyi Regional Hospital, Khmelnytskyi, , Ukraine
Poltava Regional Clinical Hospital named after M. V. Sklifosovskoho, Poltava, , Ukraine
Heart of England NHS Foundation Trust - Heartlands Hospital, Birmingham, , United Kingdom
University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital, Canterbury, , United Kingdom
St. James's University Hospital, Leeds, , United Kingdom
Contact Details
Name: Harold N Keer, MD, PhD
Affiliation: Astex Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR
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