SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction

Last updated: July 31, 2024
Sponsor: Astex Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Leukemia

Treatment

Treatment Choice

SGI-110 (guadecitabine)

Clinical Study ID

NCT02348489
SGI-110-04
  • Ages > 18
  • All Genders

Study Summary

To compare efficacy and safety between SGI-110 and Treatment Choice in adults with previously untreated AML who are not considered candidates for intensive remission induction chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) according to World Health Organization (WHO) classification.

Performance status (ECOG) of 0-3. Adults with previously untreated AML except for hydroxyurea or corticosteroids. Prior hydroxyurea or lenalidomide treatment for myelodysplastic syndrome (MDS) is allowed.

Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:

  1. ≥75 years of age OR

  2. <75 years of age with at least 1 of the following:

i. Poor performance status (ECOG) score of 2-3.

ii. Clinically significant heart or lung comorbidities, as reflected by at least 1 of:

  1. Left ventricular ejection fraction (LVEF) ≤50%.

  2. Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.

  3. Forced expiratory volume in 1 second (FEV1) ≤65% of expected.

  4. Chronic stable angina or congestive heart failure controlled with medication.

iii. Liver transaminases >3 × upper limit of normal (ULN).

iv. Other contraindication(s) to anthracycline therapy (must be documented).

v. Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the study medical monitor before randomization.

Creatinine clearance as estimated by the Cockcroft-Gault (C-G) or other medically acceptable formulas ≥30 mL/min.

Exclusion

Exclusion Criteria:

Candidate for intensive remission induction chemotherapy at the time of enrollment.

Candidate for best supportive care only, ie, not a candidate for any active therapy with the TC comparators.

Known extramedullary central nervous system (CNS) AML.

Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy.

Prior treatment with decitabine or azacitidine.

Hypersensitivity to decitabine, SGI-110, or SGI-110 excipients.

Known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status or low viral hepatitis titer on antivirals is allowed.

Known significant mental illness or other condition such as active alcohol or other substance abuse or addiction that, in the opinion of the investigator, predisposes the subject to high risk of noncompliance with the protocol.

Refractory congestive heart failure unresponsive to medical treatment; active infection resistant to all antibiotics; or advanced pulmonary disease requiring >2 liters per minute (LPM) oxygen.

Study Design

Total Participants: 815
Treatment Group(s): 2
Primary Treatment: Treatment Choice
Phase: 3
Study Start date:
March 19, 2015
Estimated Completion Date:
June 17, 2019

Connect with a study center

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria
    Australia

    Site Not Available

  • Medizinische Universität Graz

    Graz, Styria
    Austria

    Site Not Available

  • Hanusch Krankenhaus Wiener Gebietskrankenkasse

    Wien, Vienna
    Austria

    Site Not Available

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut 6061
    Belgium

    Site Not Available

  • UZ Gent

    Ghent, Oost-vlaanderen 9000
    Belgium

    Site Not Available

  • Algemeen Ziekenhuis Sint-Jan

    Brugge, West-vlaanderen 8000
    Belgium

    Site Not Available

  • Specialized Hospital for Active Treatment of Hematology Diseases EAD

    Sofia, Sofiya
    Bulgaria

    Site Not Available

  • UMHAT 'Sveti Georgi' EAD

    Plovdiv,
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD

    Varna,
    Bulgaria

    Site Not Available

  • Tom Baker Cancer Center

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta 76B 2B7
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario
    Canada

    Site Not Available

  • Fakultní nemocnice Brno

    Brno, Jihormoravsky KRAJ
    Czechia

    Site Not Available

  • Všeobecná fakultní nemocnice v Praze

    Praha 2, Praha
    Czechia

    Site Not Available

  • Fakultní nemocnice Královské Vinohrady

    Praha 10, Praha 10
    Czechia

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 8000
    Denmark

    Site Not Available

  • Rigshospitalet-Copenhagen University Hospital

    Copenhagen,
    Denmark

    Site Not Available

  • Rigshospitalet-Copenhagen University Hospital

    Copenhagen OE,
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense,
    Denmark

    Site Not Available

  • Tampere University Hospital

    Tampere, Southern Finland
    Finland

    Site Not Available

  • Helsinki University Central Hospital

    Helsinki,
    Finland

    Site Not Available

  • GHR Mulhouse Sud-Alsace

    Mulhouse Cedex, Alsace
    France

    Site Not Available

  • Hôpital Hôtel-Dieu

    Bayonne, Aquitaine
    France

    Site Not Available

  • Centre Henri-Becquerel

    Rouen Cedex 1, Haute-normandie
    France

    Site Not Available

  • Hôpital Saint Louis

    Paris Cedex 10, Ile-de-france 75010
    France

    Site Not Available

  • CHRU de Limoges - Hôpital Dupuytren

    Limoges Cedex, Limousin, Lorraine 87000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse cedex 9, Midi-pyrenees
    France

    Site Not Available

  • Hôpital Hôtel-Dieu

    Nantes cedex 1, PAYS DE LA Loire
    France

    Site Not Available

  • Center Hospitalier Universitaire d' Angers

    Angers Cedex 9, Pays de La Loire
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille Cedex 9, Provence Alpes COTE D'azur
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, Provence Alpes COTE D'azur
    France

    Site Not Available

  • Centre Hospitalier Universitaire Grenoble

    La Tronche, Rhone-alpes 38700
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon Cedex 08, Rhone-alpes
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Bénite Cedex, Rhone-alpes
    France

    Site Not Available

  • Universitaetsklinikum Freiburg

    Freiburg, Baden-wuerttemberg
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, Baden-wuerttemberg
    Germany

    Site Not Available

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, Baden-wuerttemberg
    Germany

    Site Not Available

  • Medizinische Klinik und Poliklinik III

    München, Bayern
    Germany

    Site Not Available

  • Universitätsklinikum Frankfurt Goethe Universität

    Frankfurt am Main, Hessen
    Germany

    Site Not Available

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, Niedersachsen 38114
    Germany

    Site Not Available

  • Marien Hospital Düsseldorf GmbH

    Düsseldorf, Nordrhein-westfalen
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-holstein
    Germany

    Site Not Available

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bacs-kiskun
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1085
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400
    Hungary

    Site Not Available

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, Pesaro E Urbino
    Italy

    Site Not Available

  • IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture

    Rionero in Vulture, Potenza
    Italy

    Site Not Available

  • Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

    Orbassano, Torino
    Italy

    Site Not Available

  • Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

    Alessandria,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

    Bologna,
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedale di Busto Arsizio

    Busto Arsizio, 21052
    Italy

    Site Not Available

  • Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

    Catania,
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST

    Genova,
    Italy

    Site Not Available

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milano,
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena,
    Italy

    Site Not Available

  • AORN A. Cardarelli

    Napoli,
    Italy

    Site Not Available

  • Azienda Policlinico Umberto I di Roma

    Roma,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

    Udine,
    Italy

    Site Not Available

  • Nagoya University Hospital

    Aichi,
    Japan

    Site Not Available

  • Akita University Hospital

    Akita,
    Japan

    Site Not Available

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyo,
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyou-ku,
    Japan

    Site Not Available

  • Narita Red Cross Hospital

    Chiba,
    Japan

    Site Not Available

  • Chubu,
    Japan

    Site Not Available

  • Chugoku,
    Japan

    Site Not Available

  • University of Fukui Hospital

    Fukui,
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka City,
    Japan

    Site Not Available

  • Saiseikai Maebashi Hospital

    Gunma,
    Japan

    Site Not Available

  • Chugoku Central Hospital

    Hiroshima,
    Japan

    Site Not Available

  • Tokai University Hospital

    Isehara City,
    Japan

    Site Not Available

  • Kanto,
    Japan

    Site Not Available

  • Kinki,
    Japan

    Site Not Available

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto,
    Japan

    Site Not Available

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto,
    Japan

    Site Not Available

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto-city,
    Japan

    Site Not Available

  • Kyushu,
    Japan

    Site Not Available

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki,
    Japan

    Site Not Available

  • Osaka City University Hospital

    Osaka-shi,
    Japan

    Site Not Available

  • Saga University Hospital

    Saga,
    Japan

    Site Not Available

  • Saitama International Medical Center

    Saitama,
    Japan

    Site Not Available

  • Yamagata University Hospital

    Sendai,
    Japan

    Site Not Available

  • Kindai University Hospital

    Suita,
    Japan

    Site Not Available

  • NHO Disaster Medical Center

    Tachikawa-city,
    Japan

    Site Not Available

  • Tohoku,
    Japan

    Site Not Available

  • The Jikei University Daisan Hospital

    Tokyo,
    Japan

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Jongno Gu, Seoul
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Jongno-gu, Seoul
    Korea, Republic of

    Site Not Available

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul Saint Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht,
    Netherlands

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, Dolnoslaskie
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Lódz, Lodzkie
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, Lubelskie
    Poland

    Site Not Available

  • Instytut Hematologii i Transfuzjologii

    Warszawa, Mazowieckie
    Poland

    Site Not Available

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warszawa, Mazowieckie
    Poland

    Site Not Available

  • Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Opole, Opolskie
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

    Chorzów, Slaskie
    Poland

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Tirgu-Mures

    Targu-Mures, Mures
    Romania

    Site Not Available

  • Institutul Regional de Oncologie Iasi

    Iasi,
    Romania

    Site Not Available

  • Sverdlovsk Regional Clinical Hospital #1

    Ekaterinburg,
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Hospital

    Ryazan,
    Russian Federation

    Site Not Available

  • FGU Russian Scientific Research Institute of Hematology and Transfusiology

    Saint Petersburg,
    Russian Federation

    Site Not Available

  • Saratov State Medical University

    Saratov,
    Russian Federation

    Site Not Available

  • Clinical Center of Serbia

    Belgrade,
    Serbia

    Site Not Available

  • Clinical Centre of Vojvodina

    Novi Sad,
    Serbia

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias
    Spain

    Site Not Available

  • Hospital Son Llàtzer

    Palma de Mallorca, Baleares
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona
    Spain

    Site Not Available

  • Hospital Vall d´Hebrón

    Barcelona,
    Spain

    Site Not Available

  • Hospital San Pedro de Alcantara

    Caceres,
    Spain

    Site Not Available

  • Hospital General Virgen de las Nieves

    Granada,
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañon

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026
    Spain

    Site Not Available

  • Skånes Universitetssjukhus i Lund

    Lund, Skane
    Sweden

    Site Not Available

  • Karolinska University Hospital Huddinge

    Stockholm,
    Sweden

    Site Not Available

  • Changhua Christian Hospital

    Changhua city, Changhwa
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-LinKou Branch

    Tao-Yuan, Taoyuan
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung,
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Medway Maritime Hospital

    Gillingham, Kent, England
    United Kingdom

    Site Not Available

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, England
    United Kingdom

    Site Not Available

  • Medway Maritime Hospital

    Gillingham, Kent
    United Kingdom

    Site Not Available

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona 85259-5499
    United States

    Site Not Available

  • Scripps Cancer Center

    La Jolla, California
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Kansas Medical Center

    Westwood, Kansas 66160
    United States

    Site Not Available

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55454
    United States

    Site Not Available

  • Mayo Clinic Cancer Center

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10021
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11790
    United States

    Site Not Available

  • Duke Cancer Center

    Durham, North Carolina
    United States

    Site Not Available

  • University Hospitals Monarch Medical Center

    Cleveland, Ohio
    United States

    Site Not Available

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Temple University

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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