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Spots Global Cancer Trial Database for Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Yuri Sano, MD, PhD

Affiliation: Astex Pharmaceuticals, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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