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Brief Title: Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents
Study ID: NCT02907359
Brief Summary: A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.
Detailed Description: Multicenter, randomized, open-label, parallel-group study of guadecitabine vs Treatment Choice (TC). Approximately 408 participants will be randomly assigned 2:1 to either guadecitabine or TC. * Guadecitabine: approximately 272 participants. * TC: approximately 136 participants. Before randomization, the investigator will assign each participant to one of the following TC options: * Low dose cytarabine (LDAC). * Standard Intensive Chemotherapy (IC) of a 7+3 regimen. * Best Supportive Care (BSC) only. BSC will be provided to all participants as per standard and institutional practice. Participants randomized to TC will not be allowed to cross over to guadecitabine. Data will be reviewed by an independent Data Monitoring Committee at regular intervals, primarily to evaluate safety during study conduct. Randomization will be stratified by disease category (MDS vs CMML), bone marrow (BM) blasts (BM blasts \>10% vs BM blasts ≤10%), TC option (LDAC vs IC vs BSC), and study center region. Guadecitabine: 60 milligrams per square meter (mg/m\^2) given subcutaneously (SC) daily on Days 1-5 in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 6 total cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 6 cycles, treatment should continue as long as the participant continues to benefit. BSC should be given according to standard and institutional practice. Treatment Choice (TC): Before randomization, the investigator will assign each participant to one of the following TC options: * Low dose cytarabine (LDAC) given as 20 mg/m\^2 SC or intravenously (IV) once daily for 14 days in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 4 cycles in the absence of disease progression or unacceptable toxicity. * Standard Intensive Chemotherapy (IC) of a 7+3 regimen: given as cytarabine 100-200 mg/m\^2/day given as continuous infusion for 7 days and an anthracycline given as per institutional standard practice such as daunorubicin (45-60 mg/m\^2/day), or idarubicin (9-12 mg/m\^2/day), or mitoxantrone (8-12 mg/m\^2/day) by intravenous infusion for 3 days. * Best Supportive Care (BSC) only: given according to standard and institutional practice. BSC includes, but is not limited to blood transfusions (Red blood cells \[RBCs\] or platelets), growth factors including erythropoiesis stimulating agents (ESA), granulocyte stimulating factors (GSFs), iron chelating therapy, and broad-spectrum antibiotics and/or antifungals.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Desert Hematology Oncology Medical Group, Inc., Rancho Mirage, California, United States
Cancer Specialists of North Florida, Fleming Island, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
North Shore Medical Center, Evanston, Illinois, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
University of Maryland, Baltimore, Maryland, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
John Theurer Cancer Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Duke Cancer Center, Durham, North Carolina, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Bon Secours Saint Francis Hospital, Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
West Virginia University Mary Babb Randolph Cancer Center, Morgantown, West Virginia, United States
Ziekenhuis Netwerk Antwerpen Stuivenberg, Antwerp, , Belgium
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende, Brugge, , Belgium
Grand Hôpital de Charleroi - Notre Dame, Charleroi, , Belgium
Tom Baker Cancer Center, Calgary, Alberta, Canada
University of Alberta Hospital, Edmonton, Alberta, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Burnaby Hospital, Burnaby, , Canada
Moncton Hospital, Moncton, , Canada
Maisonneuve-Rosemont Hôpital Service d'Hematologie et d'Oncologie Medicale, Montréal, , Canada
Saskatchewan Cancer Agency, Regina, , Canada
Fakultní nemocnice Brno, Brno, , Czechia
Fakultni Nemocnice Hradec Králové, Hradec Králové, , Czechia
Fakultní nemocnice Ostrava, Ostrava, , Czechia
Onkologická klinika Všeobecná fakultní nemocnice v Praze a 1, Praha 2, , Czechia
Fakultní Nemocnice Královské Vinohrady, Praha, , Czechia
Aalborg Universitetshospital, Aalborg, , Denmark
Aarhus Universitetshospital, Aarhus, , Denmark
Rigshospitalet, Copenhagen, , Denmark
Odense University Hospital, Odense, , Denmark
Centre Hospitalier Universitaire, La Tronche, , France
Hôpital Dupuytren, Limoges, , France
GHR Mulhouse Sud-Alsace, Mulhouse Cedex, , France
Hôpital Hôtel-Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
Hôpital Saint Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Centre Hospitalier Universitaire de Toulouse, Toulouse, , France
Städtisches Klinikum Braunschweig, Braunschweig, , Germany
Marien Hospital Düsseldorf, Düsseldorf, , Germany
Universitaetsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Halle, Halle, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria, , Italy
Azienda Ospedaliero Universitaria Careggi, Firenze, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
AORN A. Cardarelli, Napoli, , Italy
Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara, Novara, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
Ospedale S. Eugenio, Roma, , Italy
NHO Nagoya Medical Center, Nagoya-shi, Aichi, Japan
Narita Red Cross Hospital, Narita, Chiba, Japan
University of Fukui Hospital, Yoshida, Fukui, Japan
Chugoku Central Hospital, Fukuyama-shi, Hiroshima, Japan
Tokai University Hospital, Isehara, Kanagawa, Japan
Kitasato University Hospital, Sagamihara-shi, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital, Yokohama, Kanagawa, Japan
Nagasaki University Hospital, Nagasaki, Nagasaki-shi, Japan
Kansai Medical University Hirakata, Hirakata, Osaka, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
Saitama Medical Center, Kawagoe, Saitama, Japan
Nippon Medical School Hospital, Bunkyō-Ku, Tokyo, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto, Tokyo, Japan
NTT Medical Center Tokyo, Shinagawa, Tokyo, Japan
National Hospital Organization Disaster Medical Center, Tachikawa, Tokyo, Japan
National Hospital Organization Kyushu, Fukuoka, , Japan
Fukushima Medical University, Fukushima, , Japan
Gifu Municipal Hospital, Gifu, , Japan
National Hospital Organization Kumamoto Medical Center, Kumamoto, , Japan
Japanese Red Cross Kyoto Daini Hospital, Kyoto, , Japan
University Hospital-Kyoto Prefectural University of Medicine, Kyoto, , Japan
Yamagata University Hospital, Yamagata, , Japan
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Ulsan University Hospital, Ulsan, , Korea, Republic of
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczny, Warszawa, , Poland
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitari Germans Trias i Pujol, Badalona, , Spain
Fundació Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital de León, León, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Ramón Y Cajal, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Sahlgrenska Universitetssjukhuset, Östra sjukhuset, Göteborg, , Sweden
Universitetssjukhuset Örebro, Örebro, , Sweden
Medway NHS Foundation Trust, Gillingham, , United Kingdom
The Leeds Teaching Hospitals NHS Trust, Leeds, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust, London, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Name: Yuri Sano, MD, PhD
Affiliation: Astex Pharmaceuticals, Inc.
Role: STUDY_DIRECTOR