SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
Leukemia, Myeloid, Acute
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring AML, Acute Myeloid Leukemia, SGI-110, DNA Hypomethylating Agen
Eligibility Criteria
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:
- ≥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.
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.
Sites / Locations
- Mayo Clinic Cancer Center
- Scripps Cancer Center
- University of Southern California
- University of Chicago
- University of Kansas Medical Center
- University of Minnesota Medical Center
- Mayo Clinic Cancer Center
- John Theurer Cancer Center at Hackensack
- University of New Mexico Cancer Center
- Roswell Park Cancer Institute
- Weill Cornell Medical College
- Columbia University Medical Center
- Stony Brook University Medical Center
- Duke Cancer Center
- University Hospitals of Cleveland
- University Hospitals Monarch Medical Center
- Penn State Milton S. Hershey Medical Center
- Temple University
- Western Pennsylvania Hospital
- Vanderbilt University Medical Center
- MD Anderson Cancer Center
- University of Wisconsin
- Medical College of Wisconsin
- Concord Repatriation General Hospital
- Royal Adelaide Hospital
- Monash Medical Centre
- Austin Health
- Medizinische Universität Graz
- Hanusch Krankenhaus Wiener Gebietskrankenkasse
- Grand Hôpital de Charleroi
- UZ Gent
- Algemeen Ziekenhuis Sint-Jan
- UMHAT 'Sveti Georgi' EAD
- Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD
- Tom Baker Cancer Center
- University of Alberta Hospital
- Vancouver General Hospital
- The Ottawa Hospital
- Princess Margaret Hospital
- Sunnybrook Health Sciences Centre
- Fakultní nemocnice Brno
- Všeobecná fakultní nemocnice v Praze
- Fakultní nemocnice Královské Vinohrady
- Aarhus University Hospital
- Rigshospitalet-Copenhagen University Hospital
- Odense University Hospital
- Tampere University Hospital
- Helsinki University Central Hospital
- GHR Mulhouse Sud-Alsace
- Hôpital Hôtel-Dieu
- Centre Henri-Becquerel
- Hôpital Saint Louis
- CHRU de Limoges - Hôpital Dupuytren
- Centre Hospitalier Universitaire de Toulouse
- Hôpital Hôtel-Dieu
- Institut Paoli Calmettes
- Centre Antoine Lacassagne
- Centre Hospitalier Universitaire Grenoble
- Centre Léon Bérard
- Centre Hospitalier Lyon Sud
- Universitaetsklinikum Freiburg
- Universitätsklinikum Ulm
- Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
- Universitätsklinikum Frankfurt Goethe Universität
- Städtisches Klinikum Braunschweig gGmbH
- Marien Hospital Düsseldorf GmbH
- Universitätsklinikum Schleswig-Holstein
- Bacs-Kiskun Megyei Korhaz
- Semmelweis Egyetem
- Debreceni Egyetem Klinikai Kozpont
- Somogy Megyei Kaposi Mór Oktató Kórház
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
- Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
- Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
- Azienda Ospedaliera Ospedale di Busto Arsizio
- Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliero-Universitaria Policlinico di Modena
- AORN A. Cardarelli
- Azienda Policlinico Umberto I di Roma
- Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
- Seoul National University Bundang Hospital
- Chonnam National University Hwasun Hospital
- Seoul National University Hospital
- Inje University Busan Paik Hospital
- Kyungpook National University Hospital
- Asan Medical Center
- Samsung Medical Center
- Seoul Saint Mary's Hospital
- Severance Hospital, Yonsei University Health System
- Ulsan University Hospital
- Universitair Medisch Centrum Utrecht
- Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
- Wojewodzki Szpital Specjalistyczny im. M. Kopernika
- Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
- Instytut Hematologii i Transfuzjologii
- Samodzielny Publiczny Centralny Szpital Kliniczny
- Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
- Spitalul Clinic Judetean de Urgenta Tirgu-Mures
- Institutul Regional de Oncologie Iasi
- Sverdlovsk Regional Clinical Hospital #1
- Ryazan Regional Clinical Hospital
- Saratov State Medical University
- Clinical Center of Serbia
- Clinical Centre of Vojvodina
- Hospital Universitario Central de Asturias
- Hospital Universitari Germans Trias i Pujol
- Hospital Vall d´Hebrón
- Hospital San Pedro de Alcantara
- Hospital General Virgen de las Nieves
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario 12 de Octubre
- Hospital Clínico Universitario de Salamanca
- Hospital Universitario Virgen del Rocio
- Hospital Universitari i Politecnic La Fe de Valencia
- Skånes Universitetssjukhus i Lund
- Karolinska University Hospital Huddinge
- Chang Gung Medical Foundation-LinKou Branch
- China Medical University Hospital
- Mackay Memorial Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Chelsea and Westminster Hospital NHS Foundation Trust
- King's College Hospital
- Medway Maritime Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
SGI-110 (guadecitabine)
Treatment Choice
Guadecitabine 60 mg/m^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
One 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.