Last updated on June 2018

Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs


Brief description of study

A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in subjects 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 subjects from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 subjects) or Treatment Choice (approximately 136 subjects). The study consists of 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 more than 2 years, and the duration of individual subject participation will vary. Subjects may continue to receive treatment for as long as they continue to benefit.

Detailed Study Description

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs Treatment Choice (TC). Approximately 408 subjects will be randomly assigned 2:1 to either guadecitabine or TC.

  • Guadecitabine: approximately 272 subjects.
  • TC: approximately 136 subjects.

Before randomization, the investigator will assign each subject 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 subjects as per standard and institutional practice. Subjects 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 mg/m2 given 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 subject continues to benefit. BSC should be given according to standard and institutional practice.

Treatment Choice (TC): Before randomization, the investigator will assign each subject to one of the following TC options:

  • Low dose cytarabine (LDAC) given as 20 mg/m2 SC or 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/m2/day given as continuous infusion for 7 days and an anthracycline given as per institutional standard practice such as daunorubicin (45-60 mg/m2/day), or idarubicin (9-12 mg/m2/day), or mitoxantrone (8-12 mg/m2/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 (RBCs or platelets), growth factors including erythropoiesis stimulating agents (ESA), granulocyte stimulating factors (GSFs), iron chelating therapy, and broad spectrum antibiotics and/or antifungals.

Clinical Study Identifier: NCT02907359

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Harold Keer, MD, PhD

City of Hope
Duarte, CA United States
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Harold Keer, MD, PhD

Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, CA United States
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Harold Keer, MD, PhD

Cancer Specialists of North Florida
Fleming Island, FL United States
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Harold Keer, MD, PhD

Mount Sinai Medical Center
Miami Beach, FL United States
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Harold Keer, MD, PhD

Rush University Medical Center
Chicago, IL United States
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Harold Keer, MD, PhD

North Shore Medical Center
Evanston, IL United States
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Harold Keer, MD, PhD

University of Maryland
Baltimore, MD United States
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Harold Keer, MD, PhD

University of Michigan Cancer Center
Ann Arbor, MI United States
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Harold Keer, MD, PhD

John Theurer Cancer Center
Hackensack, NJ United States
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Harold Keer, MD, PhD

Roswell Park Cancer Institute
Buffalo, NY United States
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Harold Keer, MD, PhD

Weill Cornell Medical College
New York, NY United States
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Harold Keer, MD, PhD

Stony Brook University Medical Center
Stony Brook, NY United States
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Harold Keer, MD, PhD

Duke Cancer Center
Durham, NC United States
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Harold Keer, MD, PhD

Penn State Milton S. Hershey Medical Center
Hershey, PA United States
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Harold Keer, MD, PhD

Fox Chase Cancer Center
Philadelphia, PA United States
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Harold Keer, MD, PhD

Medical University of South Carolina
Charleston, SC United States
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Harold Keer, MD, PhD

Bon Secours Saint Francis Hospital
Greenville, SC United States
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Harold Keer, MD, PhD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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Harold Keer, MD, PhD

Fred Hutchinson Cancer Research Center
Seattle, WA United States
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Harold Keer, MD, PhD

West Virginia University Mary Babb Randolph Cancer Center
Morgantown, WV United States
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Harold Keer, MD, PhD

Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium
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Harold Keer, MD, PhD

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
Brugge, Belgium
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Harold Keer, MD, PhD

Grand H pital de Charleroi - Notre Dame
Charleroi, Belgium
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Harold Keer, MD, PhD

Tom Baker Cancer Center
Calgary, AB Canada
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Harold Keer, MD, PhD

University of Alberta Hospital
Edmonton, AB Canada
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Harold Keer, MD, PhD

Royal Victoria Regional Health Centre
Barrie, ON Canada
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Harold Keer, MD, PhD

Juravinski Cancer Centre
Hamilton, ON Canada
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Harold Keer, MD, PhD

Princess Margaret Hospital
Toronto, ON Canada
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Harold Keer, MD, PhD

Fakultn nemocnice Brno
Brno, Czechia
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Harold Keer, MD, PhD

Onkologick klinika V eobecn fakultn nemocnice v Praze a 1
Praha 2, Czechia
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Harold Keer, MD, PhD

Fakultn Nemocnice Kr lovsk Vinohrady
Praha, Czechia
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Harold Keer, MD, PhD

Centre Hospitalier Universitaire
La Tronche, France
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Harold Keer, MD, PhD

GHR Mulhouse Sud-Alsace
Mulhouse Cedex, France
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Harold Keer, MD, PhD

H pital H tel-Dieu
Nantes, France
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Harold Keer, MD, PhD

Centre Antoine Lacassagne
Nice, France
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Harold Keer, MD, PhD

H pital Saint Louis
Paris, France
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Harold Keer, MD, PhD

Centre Hospitalier Universitaire de Toulouse
Toulouse, France
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Harold Keer, MD, PhD

St dtisches Klinikum Braunschweig
Braunschweig, Germany
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Harold Keer, MD, PhD

Universitaetsklinikum Freiburg
Freiburg, Germany
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Universit tsklinikum Halle
Halle, Germany
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Harold Keer, MD, PhD

Universit tsklinikum Ulm
Ulm, Germany
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Harold Keer, MD, PhD

Azienda Ospedaliero Universitaria Careggi
Firenze, Italy
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Harold Keer, MD, PhD

Seoul National University Hospital
Seoul, Korea, Republic of
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Harold Keer, MD, PhD

Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Harold Keer, MD, PhD

Asan Medical Center
Seoul, Korea, Republic of
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Harold Keer, MD, PhD

Samsung Medical Center
Seoul, Korea, Republic of
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Seoul Saint Mary's Hospital
Seoul, Korea, Republic of
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Ulsan University Hospital
Ulsan, Korea, Republic of
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Hospital Universitari Germans Trias i Pujol
Badalona, Spain
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Harold Keer, MD, PhD

Fundaci Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
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Harold Keer, MD, PhD

Hospital Universitario Vall d'Hebron
Barcelona, Spain
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Hospital General Universitario Gregorio Mara on
Madrid, Spain
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Medway NHS Foundation Trust
Gillingham, United Kingdom
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Harold Keer, MD, PhD

Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
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Harold Keer, MD, PhD

Swedish Cancer Institute
Seattle, WA United States
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Harold Keer, MD, PhD

Fakultn nemocnice Ostrava
Ostrava, Czechia
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Harold Keer, MD, PhD

H pital Dupuytren
Limoges, France
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Harold Keer, MD, PhD

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano, Italy
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Harold Keer, MD, PhD

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland
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Harold Keer, MD, PhD

Instytut Hematologii i Transfuzjologii
Warszawa, Poland
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Harold Keer, MD, PhD

Hospital Universitario 12 de Octubre
Madrid, Spain
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Hospital Universitario de Salamanca
Salamanca, Spain
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Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
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The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
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Harold Keer, MD, PhD

Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom
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Harold Keer, MD, PhD

Azienda Ospedaliera Universitaria San Martino
Genova, Italy
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Ospedale S. Eugenio
Roma, Italy
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Franciscan Health Indianapolis
Indianapolis, IN United States
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AORN A. Cardarelli
Napoli, Italy
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Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Italy
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Moncton Hospital
Moncton, Canada
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Saskatchewan Cancer Agency
Regina, Canada
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Rigshospitalet
Copenhagen, Denmark
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Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, Italy
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Aalborg Universitetshospital
Aalborg, Denmark
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Aarhus Universitetshospital
Aarhus, Denmark
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Odense University Hospital
Odense, Denmark
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Maisonneuve-Rosemont H pital Service d'Hematologie et d'Oncologie Medicale
Montréal, Canada
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Fakultni Nemocnice Hradec Kr lov
Hradec Králové, Czechia
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Harold Keer, MD, PhD

Centre Hospitalier Lyon Sud
Pierre-Bénite, France
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Harold Keer, MD, PhD

Marien Hospital D sseldorf
Düsseldorf, Germany
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Harold Keer, MD, PhD

Hospital San Pedro de Alcantara
Cáceres, Spain
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