SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
A Phase 3, Multicenter, Open-label, Randomized Study of SGI-110 Versus Treatment Choice (TC) in Adults With Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Considered Candidates for Intensive Remission Induction Chemotherapy
1 other identifier
interventional
815
22 countries
129
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2015
Typical duration for phase_3
129 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedStudy Start
First participant enrolled
March 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2019
CompletedResults Posted
Study results publicly available
January 14, 2021
CompletedAugust 27, 2024
July 1, 2024
3.2 years
January 22, 2015
November 11, 2020
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With a Complete Response (CR)
Number of participants with a best response of CR assessed based on International Working Group 2003 acute myeloid leukemia (AML) response criteria by a blinded independent pathologist.
Up to 38 months (median follow-up of 25.5 months)
Overall Survival
Survival time was defined as the number of days from the day the participant was randomly assigned to study treatment to the date of death, regardless of cause.
At 676 death events (up to 38 months)
Secondary Outcomes (7)
Number of Participants With Composite CR (CRc)
Up to 38 months (median follow-up of 25.5 months)
Number of Days Alive and Out of the Hospital
Month 6
Progression-free Survival (PFS)
Up to 38 months (median follow-up of 25.5 months)
Number of Red Blood Cell or Platelet Transfusions
Month 6
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Baseline to Month 6
- +2 more secondary outcomes
Study Arms (2)
SGI-110 (guadecitabine)
EXPERIMENTALGuadecitabine 60 mg/m\^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
Treatment Choice
ACTIVE COMPARATOROne of the following treatment regimens: 20 mg cytarabine administered subcutaneously (SC) twice daily (BID) on Days 1-10 every 28 days; 20 mg/m\^2 decitabine given as a 1-hour intravenous (IV) infusion daily on Days 1-5 every 28 days; or 75 mg/m\^2 azacitidine given IV or SC daily on Days 1-7 every 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- ≥75 years of age OR
- \<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:
- Left ventricular ejection fraction (LVEF) ≤50%.
- Lung diffusing capacity for carbon monoxide (DLCO) ≤65% of expected.
- Forced expiratory volume in 1 second (FEV1) ≤65% of expected.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (135)
Mayo Clinic Cancer Center
Scottsdale, Arizona, 85259-5499, United States
Scripps Cancer Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, 90033, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Kansas Medical Center
Westwood, Kansas, 66160, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
John Theurer Cancer Center at Hackensack
Hackensack, New Jersey, 07601, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10065, United States
Stony Brook University Medical Center
Stony Brook, New York, 11790, United States
Duke Cancer Center
Durham, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
University Hospitals Monarch Medical Center
Cleveland, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University
Philadelphia, Pennsylvania, 19111, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, Australia
Medizinische Universität Graz
Graz, Styria, Austria
Hanusch Krankenhaus Wiener Gebietskrankenkasse
Vienna, Vienna, Austria
Grand Hôpital de Charleroi
Charleroi, Hainaut, 6061, Belgium
UZ Gent
Ghent, Oost-vlaanderen, 9000, Belgium
Algemeen Ziekenhuis Sint-Jan
Bruges, West-vlaanderen, 8000, Belgium
UMHAT 'Sveti Georgi' EAD
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD
Varna, Bulgaria
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2, Canada
University of Alberta Hospital
Edmonton, Alberta, 76B 2B7, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Fakultní nemocnice Brno
Brno, Jihormoravsky KRAJ, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, Prague, Czechia
Fakultní nemocnice Královské Vinohrady
Prague, Praha 10, Czechia
Aarhus University Hospital
Aarhus, 8000, Denmark
Rigshospitalet-Copenhagen University Hospital
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Tampere University Hospital
Tampere, Southern Finland, Finland
Helsinki University Central Hospital
Helsinki, Finland
GHR Mulhouse Sud-Alsace
Mulhouse, Alsace, France
Hôpital Hôtel-Dieu
Bayonne, Aquitaine, France
Centre Hospitalier Universitaire Grenoble
La Tronche, Auvergne-Rhône-Alpes, 38700, France
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Henri-Becquerel
Rouen, Haute-normandie, France
CHRU de Limoges - Hôpital Dupuytren
Limoges, Limousin, Lorraine, 87000, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, Midi-pyrenees, France
Hôpital Hôtel-Dieu
Nantes, Pays de la Loire Region, France
Institut Paoli Calmettes
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Antoine Lacassagne
Nice, Provence-Alpes-Côte d'Azur Region, France
Hôpital Saint Louis
Paris, Île-de-France Region, 75010, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Universitätsklinikum Frankfurt Goethe Universität
Frankfurt am Main, Hesse, Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Lower Saxony, 38114, Germany
Marien Hospital Düsseldorf GmbH
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany
Bacs-Kiskun Megyei Korhaz
Kecskemét, Bács-Kiskun county, Hungary
Semmelweis Egyetem
Budapest, 1085, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Pesaro, Pesaro E Urbino, Italy
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
Alessandria, Italy
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, Italy
Azienda Ospedaliera Ospedale di Busto Arsizio
Busto Arsizio, 21052, Italy
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
Catania, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST
Genova, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy
AORN A. Cardarelli
Napoli, Italy
Azienda Policlinico Umberto I di Roma
Roma, Italy
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
Udine, Italy
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Kanto, Japan
Unknown Facility
Kinki, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Tōhoku, Japan
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Lublin Voivodeship, Poland
Instytut Hematologii i Transfuzjologii
Warsaw, Masovian Voivodeship, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Opole, Opole Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
Chorzów, Silesian Voivodeship, Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lódz, Łódź Voivodeship, Poland
Spitalul Clinic Judetean de Urgenta Tirgu-Mures
Târgu Mureş, Mureș County, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
Ryazan Regional Clinical Hospital
Ryazan, Russia
Saratov State Medical University
Saratov, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Russia
Clinical Center of Serbia
Belgrade, Serbia
Clinical Centre of Vojvodina
Novi Sad, Serbia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Seoul National University Hospital
Jongno Gu, Seoul, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul Saint Mary's Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Vall d´Hebrón
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Hospital General Virgen de las Nieves
Granada, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Skånes Universitetssjukhus i Lund
Lund, Skåne County, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Chang Gung Medical Foundation-LinKou Branch
Taoyuan District, Taoyuan, Taiwan
China Medical University Hospital
Taichung, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chelsea and Westminster Hospital NHS Foundation Trust
London, England, United Kingdom
King's College Hospital
London, England, United Kingdom
Medway Maritime Hospital
Gillingham, Kent, United Kingdom
Related Publications (1)
Fenaux P, Gobbi M, Kropf PL, Issa JJ, Roboz GJ, Mayer J, Krauter J, Robak T, Kantarjian H, Novak J, Jedrzejczak WW, Thomas X, Ojeda-Uribe M, Miyazaki Y, Min YH, Yeh SP, Brandwein J, Gercheva-Kyuchukova L, Demeter J, Griffiths E, Yee K, Dohner K, Hao Y, Keer H, Azab M, Dohner H. Guadecitabine vs treatment choice in newly diagnosed acute myeloid leukemia: a global phase 3 randomized study. Blood Adv. 2023 Sep 12;7(17):5027-5037. doi: 10.1182/bloodadvances.2023010179.
PMID: 37276510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Taiho Central
- Organization
- Taiho Oncology, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2015
First Posted
January 28, 2015
Study Start
March 19, 2015
Primary Completion
May 31, 2018
Study Completion
June 17, 2019
Last Updated
August 27, 2024
Results First Posted
January 14, 2021
Record last verified: 2024-07