Last updated on June 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
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Howard Weiner

The University of Chicago Medical Center
Chicago, IL United States
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Isabella van der Merwe

Franciscan Research Center
Indianapolis, IN United States
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Gillian Velardi

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

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

Roswell Park Cancer Institute
Buffalo, NY United States
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Latia Skerving

Weill Cornell Medical College
New York, NY United States
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Sebastian Munoz

Stony Brook University Hospital
Stony Brook, NY United States
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Rachel Stowe

Duke Cancer Institute
Durham, NC United States
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Lilanee Chanyothi

Temple University Hospital
Philadelphia, PA United States
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Channing Dudley

Vanderbilt University Medical Center
Nashville, TN United States
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Ameena Manzoor

MD Anderson Cancer Center
Houston, TX United States
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Neil Bailey

Swedish Cancer Institute
Seattle, WA United States
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Patricia Beal

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

AZ Sint-Jan Brugge-Oostende AV
Brugge, Belgium
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Jonas Segaert

Universitair Ziekenhuis Gent
Gent, Belgium
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Jeff Greenway

Tom Baker Cancer Centre
Calgary, AB Canada
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Jane Lin

University of Alberta Hospital
Edmonton, AB Canada
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Jennifer Kim

Princess Margaret Cancer Centre
Toronto, ON Canada
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Vera Sabadash

CHRU Montpellier - Saint Eloi
Montpellier, France
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Céline Haby

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

H pital Saint-Louis
Paris, France
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Isabelle De Ponnat

Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France
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Gabriella Mezei

Debreceni Egyetem Klinikai K zpont
Debrecen, Hungary
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Éva Meskuláné Szilágyi

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

Szegedi Tudom nyegyetem
Szeged, Hungary
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Eun Jin Kim

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

Pusan National University Hospital
Busan, Korea, Republic of
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Ju-Hyun Lee

Seoul National University Hospital
Seoul, Korea, Republic of
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So-Young Choi

Severance Hospital
Seoul, Korea, Republic of
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Jayeon Kim

Samsung Medical Center
Seoul, Korea, Republic of
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Hae Jin Kang

Ulsan University Hospital (UUH)
Ulsan, Korea, Republic of
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Marta Hernández Martín

Hospital General Universitario Gregorio Mara n
Madrid, Spain
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Lavina Davey

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

University of Oklahoma Medical Center
Oklahoma City, OK United States
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Tyler Sylk

Hospital of the University of Pennsylvania
Philadelphia, PA United States
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Dolly Davis

Baylor Research Institute
Dallas, TX United States
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Celine Pedreira

Cliniques Universitaires Saint-Luc
Brussels, Belgium
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Edith Vincent

Centre Hospitalier de la C te Basque
Bayonne, France
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Céline Philippon

CHU Limoges
Limoges Cedex, France
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Maurine Duhayon

H pital de la Conception
Marseille, France
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Virginie Bayon

Centre Henri Becquerel
Rouen cedex 1, France
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Sandra Otto

Universit tsklinikum Leipzig
Leipzig, Germany
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Antje Kleinbauer

Universit tsklinikum Halle (Saale)
Halle, Germany
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Gyorgy Nagy

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

IRCCS AOU San Martino - IST
Genova, Italy
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Giuseppina Biscardi

Fondazione IRCCS C Granda Ospedale Maggiore Policlinico
Milano, Italy
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Stefania Trinca

Ospedale San Raffaele - Milano
Milano, Italy
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Miho Matsumoto

Chugoku Central Hospital
Fukuyama-Shi, Japan
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Miki Miyamoto

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

Gunmaken Saiseikai Maebashi Hospital
Maebashi-shi, Japan
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Keiko Kamichika

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

Kindai University Hospital
Osakasayama-Shi, Japan
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Akemi Sato

Saga University Hospital
Saga-shi, Japan
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Masako Suzuki

NTT Medical Center Tokyo
Shinagawa-Ku, Japan
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Sachiko Osawa

Yamagata University Hospital
Yamagata-Shi, Japan
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Yuka Matsuo

University of Fukui Hospital
Yoshida-Gun, Japan
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Hyangki Lee

Asan Medical Center
Seoul, Korea, Republic of
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Eunha Kim

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

Instytut Hematologii i Transfuzjologi
Warszawa, Poland
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Toni de la Riva

Hospital Cl nic de Barcelona
Barcelona, Spain
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Pepa Rosal Muntadas-Prim

Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
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Francesc Garcia Pallarols

Hospital del Mar
Barcelona, Spain
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Verónica Motino Godoy

Vall d'Hebron Institut d'Oncologia
Barcelona, Spain
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Paloma Ramos

Hospital Universitario Ram n y Cajal
Madrid, Spain
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Estefania Vargas

Hospital Universitario Central de Asturias
Oviedo, Spain
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Celia Cifuentes

Hospital Universitario Virgen del Roc o
Sevilla, Spain
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David Ivars

Hospital Universitario Dr. Peset
Valencia, Spain
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David Pellicer

Hospital Universitari i Polit cnic La Fe
Valencia, Spain
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Sundip Sohanpal

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

The University of Arizona Cancer Center
Tucson, AZ United States
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Asmae Oulbacha

McGill University Health Centre
Montreal, QC Canada
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Julie Trinh Lu

Hopital Maisonneuve Rosemont
Montreal, Canada
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Oliver Streitbürger

St dtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
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Monika Fischer

Universit tsklinikum Heidelberg
Heidelberg, Germany
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Silke Trautmann-Harder

Universit tsklinikum Schleswig-Holstein
Kiel, Germany
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Daniela Dörres

Klinikum der Universit t M nchen
Muenchen, Germany
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Dorothea Paul

Universit tsklinikum Ulm
Ulm, Germany
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Luisa Copia

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

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

Tokai University Hospital
Isehara-shi, Japan
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Yoshiko Murakami

Saitama Medical Center
Kawagoe-Shi, Japan
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Miki Tsuruno

Japanese Red Cross Kyoto Daini Hospital
Kyoto-shi, Japan
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Mineko Okuzono

Nagasaki University Hospital
Nagasaki-shi, Japan
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Yukiko Takada

Japanese Red Cross Narita Hospital
Narita-shi, Japan
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Syoko Fujita

National Hospital Organization Disaster Medical Center
Tachikawa-Shi, Japan
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Ingrid Gejel

Aarhus University Hospital
Aarhus C, Denmark
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Aline Schenk

Charit - Universit tsmedizin Berlin
Berlin, Germany
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Susanne Kappes

Universit tsklinikum Freiburg
Freiburg, Germany
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Olga Polack

Universit tsmedizin Rostock
Rostock, Germany
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Olga Jankowska-Lecka

Samodzielny Publiczny Szpital Kliniczny Nr. 1
Lublin, Poland
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Oleksandr Hordiienko

Khmelnytskyi Regional Hospital
Khmelnytskyi, Ukraine
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Christos Paliompeis

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

Medizinischen Fakult t Mannheim der Universit t Heidelberg
Mannheim, Germany
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Giulia Ceccarelli

Ospedale S. Eugenio
Roma, Italy
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Laksmi Wilson

Akita University Hospital
Akita-shi, Japan
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Federica Loscocco

Presidio San Salvatore Muraglia
Pesaro, Italy
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Stine Hutters

Copenhagen, Denmark
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Mohamed El Hamri

Centre Hospitalier Lyon-Sud
Pierre Bénite, France
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Vera Lohrbacher

Marien Hospital D sseldorf GmbH
Düsseldorf, Germany
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Gábor Kollár

Pecsi Tudomanyegyetem Klinikai K zpont
Pécs, Hungary
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