Last updated on September 2018

Phase 3 Randomized Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia


Brief description of study

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Subjects 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 Study Description

This Phase 3, randomized, open-label, parallel-group multicenter study of the efficacy and safety of guadecitabine in adults with previously treated 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 subject participation will vary, and subjects may continue to receive treatment for as long as they continue to benefit.

Approximately 404 subjects from approximately 100 study centers will be randomly assigned to either guadecitabine or treatment choice (TC) in a 1:1 ratio (approximately 202 subjects 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 SC at a dose of 60 mg/m2 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).

Clinical Study Identifier: NCT02920008

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Donna Fernando

University of Southern California
Los Angeles, CA United States

Howard Weiner

The University of Chicago Medical Center
Chicago, IL United States

Isabella van der Merwe

Franciscan Research Center
Indianapolis, IN United States

Gillian Velardi

John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, NJ United States

Daniel Weishampel

University of New Mexico School of Medicine
Albuquerque, NM United States

Heather Bashaw

Roswell Park Cancer Institute
Buffalo, NY United States

Latia Skerving

Weill Cornell Medical College
New York, NY United States

Sebastian Munoz

Stony Brook University Hospital
Stony Brook, NY United States

Rachel Stowe

Duke Cancer Institute
Durham, NC United States

Lilanee Chanyothi

Temple University Hospital
Philadelphia, PA United States

Channing Dudley

Vanderbilt University Medical Center
Nashville, TN United States

Ameena Manzoor

MD Anderson Cancer Center
Houston, TX United States

Neil Bailey

Swedish Cancer Institute
Seattle, WA United States

Patricia Beal

West Virginia University Hospitals, Inc.
Morgantown, WV United States

Laura Salenbien

AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium

Jonas Segaert

Universitair Ziekenhuis Gent
Gent, Belgium

Jeff Greenway

Tom Baker Cancer Centre
Calgary, AB Canada

Jane Lin

University of Alberta Hospital
Edmonton, AB Canada

Jennifer Kim

Princess Margaret Cancer Centre
Toronto, ON Canada

Vera Sabadash

CHRU Montpellier - Saint Eloi
Montpellier, France

Céline Haby

Groupe Hospitalier de la R gion de Mulhouse et Sud Alsace
Mulhouse, France

Blandine Beve

H pital Saint-Louis
Paris, France

Isabelle De Ponnat

Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France

Gabriella Mezei

Debreceni Egyetem Klinikai K zpont
Debrecen, Hungary

Éva Meskuláné Szilágyi

Somogy Megyei Kaposi M r Oktat K rh z
Kaposvar, Hungary

Agnes Nagyne

Szegedi Tudom nyegyetem
Szeged, Hungary

Eun Jin Kim

Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of

Jinyi Baek

Pusan National University Hospital
Busan, Korea, Republic of

Ju-Hyun Lee

Seoul National University Hospital
Seoul, Korea, Republic of

So-Young Choi

Severance Hospital
Seoul, Korea, Republic of

Jayeon Kim

Samsung Medical Center
Seoul, Korea, Republic of

Hae Jin Kang

Ulsan University Hospital (UUH)
Ulsan, Korea, Republic of

Marta Hernández Martín

Hospital General Universitario Gregorio Mara n
Madrid, Spain

Lavina Davey

East Kent Hospitals University NHS Foundation Trust - Kent and Canterbury Hospital
Canterbury, United Kingdom

Patricia Schuringa

University of Oklahoma Medical Center
Oklahoma City, OK United States

Tyler Sylk

Hospital of the University of Pennsylvania
Philadelphia, PA United States

Dolly Davis

Baylor Research Institute
Dallas, TX United States

Celine Pedreira

Cliniques Universitaires Saint-Luc
Brussels, Belgium

Edith Vincent

Centre Hospitalier de la C te Basque
Bayonne, France

Céline Philippon

CHU Limoges
Limoges Cedex, France

Maurine Duhayon

H pital de la Conception
Marseille, France

Virginie Bayon

Centre Henri Becquerel
Rouen cedex 1, France

Sandra Otto

Universit tsklinikum Leipzig
Leipzig, Germany

Antje Kleinbauer

Universit tsklinikum Halle (Saale)
Halle, Germany

Gyorgy Nagy

SE OK I. sz. Belgy gy szati Klinika
Budapest, Hungary

Marianna Fava

IRCCS AOU San Martino - IST
Genova, Italy

Giuseppina Biscardi

Fondazione IRCCS C Granda Ospedale Maggiore Policlinico
Milano, Italy

Stefania Trinca

Ospedale San Raffaele - Milano
Milano, Italy

Miho Matsumoto

Chugoku Central Hospital
Fukuyama-Shi, Japan

Miki Miyamoto

University Hospital, Kyoto Prefectural University of Medicine
Kyoto-shi, Japan

Noriko Seki

Gunmaken Saiseikai Maebashi Hospital
Maebashi-shi, Japan

Keiko Kamichika

The Japanese Red Cross Nagasaki Genbaku Hospital
Nagasaki-Shi, Japan

Yoko Maeda

Kindai University Hospital
Osakasayama-Shi, Japan

Akemi Sato

Saga University Hospital
Saga-shi, Japan

Masako Suzuki

NTT Medical Center Tokyo
Shinagawa-Ku, Japan

Sachiko Osawa

Yamagata University Hospital
Yamagata-Shi, Japan

Yuka Matsuo

University of Fukui Hospital
Yoshida-Gun, Japan

Hyangki Lee

Asan Medical Center
Seoul, Korea, Republic of

Eunha Kim

The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of

Malgorzata Makowska

Instytut Hematologii i Transfuzjologi
Warszawa, Poland

Toni de la Riva

Hospital Cl nic de Barcelona
Barcelona, Spain

Pepa Rosal Muntadas-Prim

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain

Francesc Garcia Pallarols

Hospital del Mar
Barcelona, Spain

Verónica Motino Godoy

Vall d'Hebron Institut d'Oncologia
Barcelona, Spain

Paloma Ramos

Hospital Universitario Ram n y Cajal
Madrid, Spain

Estefania Vargas

Hospital Universitario Central de Asturias
Oviedo, Spain

Celia Cifuentes

Hospital Universitario Virgen del Roc o
Sevilla, Spain

David Ivars

Hospital Universitario Dr. Peset
Valencia, Spain

David Pellicer

Hospital Universitari i Polit cnic La Fe
Valencia, Spain

Sundip Sohanpal

Heart of England NHS Foundation Trust - Heartlands Hospital
Birmingham, United Kingdom

Melaney Rayburn

The University of Arizona Cancer Center
Tucson, AZ United States

Asmae Oulbacha

McGill University Health Centre
Montreal, QC Canada

Julie Trinh Lu

Hopital Maisonneuve Rosemont
Montreal, Canada

Oliver Streitbürger

St dtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany

Monika Fischer

Universit tsklinikum Heidelberg
Heidelberg, Germany

Silke Trautmann-Harder

Universit tsklinikum Schleswig-Holstein
Kiel, Germany

Daniela Dörres

Klinikum der Universit t M nchen
Muenchen, Germany

Dorothea Paul

Universit tsklinikum Ulm
Ulm, Germany

Luisa Copia

A.O.R.N. "A. Cardarelli"
Napoli, Italy

Cristina Dodorico

A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia
Udine, Italy

Akiko Yamamoto

Tokai University Hospital
Isehara-shi, Japan

Yoshiko Murakami

Saitama Medical Center
Kawagoe-Shi, Japan

Miki Tsuruno

Japanese Red Cross Kyoto Daini Hospital
Kyoto-shi, Japan

Mineko Okuzono

Nagasaki University Hospital
Nagasaki-shi, Japan

Yukiko Takada

Japanese Red Cross Narita Hospital
Narita-shi, Japan

Syoko Fujita

National Hospital Organization Disaster Medical Center
Tachikawa-Shi, Japan

Ingrid Gejel

Aarhus University Hospital
Aarhus C, Denmark

Aline Schenk

Charit - Universit tsmedizin Berlin
Berlin, Germany

Susanne Kappes

Universit tsklinikum Freiburg
Freiburg, Germany

Olga Polack

Universit tsmedizin Rostock
Rostock, Germany

Olga Jankowska-Lecka

Samodzielny Publiczny Szpital Kliniczny Nr. 1
Lublin, Poland

Oleksandr Hordiienko

Khmelnytskyi Regional Hospital
Khmelnytskyi, Ukraine

Christos Paliompeis

Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, United Kingdom

Michaela Hausmann

Medizinischen Fakult t Mannheim der Universit t Heidelberg
Mannheim, Germany

Giulia Ceccarelli

Ospedale S. Eugenio
Roma, Italy

Laksmi Wilson

Akita University Hospital
Akita-shi, Japan

Federica Loscocco

Presidio San Salvatore Muraglia
Pesaro, Italy

Stine Hutters

Rigshospitalet
Copenhagen, Denmark

Barbara Caciagli

Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy

Mathieu Sauvezie

CHU Hopitaux de Bordeaux - H pital Haut-L v que
Pessac, France

Mohamed El Hamri

Centre Hospitalier Lyon-Sud
Pierre Bénite, France

Vera Lohrbacher

Marien Hospital D sseldorf GmbH
Düsseldorf, Germany

Gábor Kollár

Pecsi Tudomanyegyetem Klinikai K zpont
Pécs, Hungary