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Leukemia, Myeloid, AcutePhase 3NCT02348489

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

A Phase 3 study testing SGI-110 (guadecitabine) and Treatment Choice in people with Leukemia, Myeloid, Acute, run by Astex Pharmaceuticals, Inc. at 135 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
SGI-110 (guadecitabine) and Treatment Choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
815 participants
Where
135 sitesin 24 countries
Study dates
19 Mar 2015to 17 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Poor performance status (ECOG) score of 2-3.
Show all 15Show fewer
  • 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.
  • Liver transaminases >3 × upper limit of normal (ULN).
  • Other contraindication(s) to anthracycline therapy (must be documented).
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

135 sites in 24 countries.

135 sites in 24 countries

United States23 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • University Hospitals Monarch Medical Center

    Cleveland, Ohio

  • Duke Cancer Center

    Durham, North Carolina

  • John Theurer Cancer Center at Hackensack

    Hackensack, New Jersey, 07601

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Scripps Cancer Center

    La Jolla, California

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55454

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center

    New York, New York, 10065

  • Temple University

    Philadelphia, Pennsylvania, 19111

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Mayo Clinic Cancer Center

    Scottsdale, Arizona, 85259-5499

  • Stony Brook University Medical Center

    Stony Brook, New York, 11790

  • University of Kansas Medical Center

    Westwood, Kansas, 66160

Other trials in United States

Italy13 sites

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

    Alessandria

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

    Bologna

  • Azienda Ospedaliera Ospedale di Busto Arsizio

    Busto Arsizio, 21052

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

    Catania

  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST

    Genova

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena

  • AORN A. Cardarelli

    Naples

  • Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

    Orbassano, Torino

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, Pesaro E Urbino

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

    Rionero in Vulture, Potenza

  • Azienda Policlinico Umberto I di Roma

    Roma

  • Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine

    Udine

Other trials in Italy

France12 sites

  • Hôpital Hôtel-Dieu

    Bayonne, Aquitaine

  • Centre Hospitalier Universitaire Grenoble

    La Tronche, Auvergne-Rhône-Alpes, 38700

  • CHRU de Limoges - Hôpital Dupuytren

    Limoges, Limousin, Lorraine, 87000

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes

  • Institut Paoli Calmettes

    Marseille, Provence-Alpes-Côte d'Azur Region

  • GHR Mulhouse Sud-Alsace

    Mulhouse, Alsace

  • Hôpital Hôtel-Dieu

    Nantes, Pays de la Loire Region

  • Centre Antoine Lacassagne

    Nice, Provence-Alpes-Côte d'Azur Region

  • Hôpital Saint Louis

    Paris, Île-de-France Region, 75010

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes

  • Centre Henri-Becquerel

    Rouen, Haute-normandie

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, Midi-pyrenees

Other trials in France

South Korea10 sites

  • Inje University Busan Paik Hospital

    Busan

  • Kyungpook National University Hospital

    Daegu

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do

  • Seoul National University Hospital

    Jongno Gu, Seoul

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul Saint Mary's Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

Spain10 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital Vall d´Hebrón

    Barcelona

  • Hospital San Pedro de Alcantara

    Cáceres

  • Hospital General Virgen de las Nieves

    Granada

  • Hospital General Universitario Gregorio Marañon

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias

  • Hospital Clínico Universitario de Salamanca

    Salamanca

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

Germany7 sites

  • Städtisches Klinikum Braunschweig gGmbH

    Braunschweig, Lower Saxony, 38114

  • Marien Hospital Düsseldorf GmbH

    Düsseldorf, North Rhine-Westphalia

  • Universitätsklinikum Frankfurt Goethe Universität

    Frankfurt am Main, Hesse

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg

  • Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

    Villingen-Schwenningen, Baden-Wurttemberg

Other trials in Germany

Poland7 sites

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

    Chorzów, Silesian Voivodeship

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Lódz, Łódź Voivodeship

  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

    Lublin, Lublin Voivodeship

  • Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Opole, Opole Voivodeship

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship

  • Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw, Masovian Voivodeship

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

    Wroclaw, Lower Silesian Voivodeship

Other trials in Poland

Canada6 sites

  • Tom Baker Cancer Center

    Calgary, Alberta, T2N 4N2

  • University of Alberta Hospital

    Edmonton, Alberta, 76B 2B7

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Japan6 sites

  • Study site

    Chūbu

  • Study site

    Chugoku

  • Study site

    Kanto

  • Study site

    Kinki

  • Study site

    Kyushu

  • Study site

    Tōhoku

Other trials in Japan

Taiwan5 sites

  • China Medical University Hospital

    Taichung

  • Mackay Memorial Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Medical Foundation-LinKou Branch

    Taoyuan, Taoyuan

Other trials in Taiwan

Australia4 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Austin Health

    Heidelberg, Victoria

Other trials in Australia

Hungary4 sites

  • Semmelweis Egyetem

    Budapest, 1085

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400

  • Bacs-Kiskun Megyei Korhaz

    Kecskemét, Bács-Kiskun county

Other trials in Hungary

Belgium3 sites

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, West-vlaanderen, 8000

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut, 6061

  • UZ Gent

    Ghent, Oost-vlaanderen, 9000

Other trials in Belgium

Czechia3 sites

  • Fakultní nemocnice Brno

    Brno, Jihormoravsky KRAJ

  • Všeobecná fakultní nemocnice v Praze

    Prague, Prague

  • Fakultní nemocnice Královské Vinohrady

    Prague, Praha 10

Other trials in Czechia

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Rigshospitalet-Copenhagen University Hospital

    Copenhagen

  • Odense University Hospital

    Odense

Other trials in Denmark

Russia3 sites

  • Ryazan Regional Clinical Hospital

    Ryazan

  • Saratov State Medical University

    Saratov

  • Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg

Other trials in Russia

United Kingdom3 sites

  • Medway Maritime Hospital

    Gillingham, Kent

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, England

  • King's College Hospital

    London, England

Other trials in United Kingdom

Austria2 sites

  • Medizinische Universität Graz

    Graz, Styria

  • Hanusch Krankenhaus Wiener Gebietskrankenkasse

    Vienna, State of Vienna

Other trials in Austria

Bulgaria2 sites

  • UMHAT 'Sveti Georgi' EAD

    Plovdiv

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

    Varna

Other trials in Bulgaria

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki

  • Tampere University Hospital

    Tampere, Southern Finland

Other trials in Finland

Romania2 sites

  • Institutul Regional de Oncologie Iasi

    Iași

  • Spitalul Clinic Judetean de Urgenta Tirgu-Mures

    Târgu Mureş, Mureș County

Other trials in Romania

Serbia2 sites

  • Clinical Center of Serbia

    Belgrade

  • Clinical Centre of Vojvodina

    Novi Sad

Other trials in Serbia

Sweden2 sites

  • Skånes Universitetssjukhus i Lund

    Lund, Skåne County

  • Karolinska University Hospital Huddinge

    Stockholm

Other trials in Sweden

Netherlands1 site

  • Universitair Medisch Centrum Utrecht

    Utrecht

Other trials in Netherlands

About this study

Official title: 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

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.

Being tested
SGI-110 (guadecitabine), Treatment Choice
Keywords
AML, Acute Myeloid Leukemia, SGI-110, DNA Hypomethylating Agen
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SGI-110 (guadecitabine)Drug

    Investigational medicinal product

  • Treatment ChoiceDrug

    Choice of one: cytarabine, decitabine, or azacitidine

Study groups in NCT02348489
Study groupRoleWhat they receive
SGI-110 (guadecitabine)ExperimentalGuadecitabine 60 mg/m^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
Receives: Drug: SGI-110 (guadecitabine)
Treatment ChoiceActive 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.
Receives: Drug: Treatment Choice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 38 months (median follow-up of 25.5 months)

  2. 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.

    Measured: At 676 death events (up to 38 months)

Secondary outcomes (7)

  1. Number of Participants With Composite CR (CRc)

    CRc is reported as the number of participants with a best response of CR, complete response with incomplete platelet recovery (CRp), or complete response with incomplete blood count recovery (CRi).

    Measured: Up to 38 months (median follow-up of 25.5 months)

  2. Number of Days Alive and Out of the Hospital

    The date of each hospital admission and discharge was collected for each participant for up to 6 months, unless the participant died or withdrew consent prior to that time. Duration of each hospital stay in days was calculated as date of discharge minus date of admission. The Number of Days Alive and Out of the Hospital (NDAOH) was calculated as: NDAOH=180 - total duration of all hospital stays within 180 days from the first treatment - number of death days before Day 180. For subjects who were lost to follow-up within 6 months, the NDAOH was calculated conservatively assuming that the subject would have died the day after the last contact day.

    Measured: Month 6

  3. Progression-free Survival (PFS)

    Progression-free survival was defined as the number of days from randomization to the earliest date of investigator's assessment of disease progression, participant receiving an alternative anti-leukemia therapy (including hematopoietic cell transplant), or relapse by peripheral blood (PB) assessment or blinded bone marrow (BM) assessment, whichever occurred first, or death, regardless of cause.

    Measured: Up to 38 months (median follow-up of 25.5 months)

  4. Number of Red Blood Cell or Platelet Transfusions

    The total number of red blood cells (RBCs) transfused or, separately, the total number of platelets transfused up to the 6-month time point for each participant was counted from the date of randomization to Day 180, the date of last contact, or date of death, whichever occurred earlier. One RBC or platelet transfusion was defined as one unit, and a single bag of RBCs or platelets was considered one unit.

    Measured: Month 6

  5. Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L

    EuroQol 5-level 5-dimension (EQ-5D-5L) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. Scores within each dimension for EQ-5D (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) were calculated using counts and proportions. Mean change in scores from baseline are summarized in which an index score of 0 represents the worst health state and 1 represents the best health state.

    Measured: Baseline to Month 6

  6. Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS

    EuroQol-Visual Analogue Scale (EQ-VAS) descriptive scores were collected for each participant for a minimum of 6 months, unless the participant died or withdrew consent. A vertical 20-cm scale for EQ-VAS was used where the lowest value of 0 was labeled "the worst health you can imagine" and the top value of 100 was labeled "the best health you can imagine." Mean change in scores from baseline are summarized.

    Measured: Baseline to Month 6

  7. Duration of CR

    Duration of CR (in number of days) was calculated from the first time a CR was observed to the time of relapse, defined as the earliest time point whereby BM assessment or PB assessment indicated relapse/disease progression due to reappearance of leukemic blasts in PB or ≥ 5% leukemic blasts in BM.

    Measured: Up to 38 months (median follow-up of 25.5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2015 (estimated)
  2. Study start19 Mar 2015
  3. Primary completion31 May 2018
  4. Study completion17 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
815 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02348489
Sponsor's protocol ID
SGI-110-04
Status last verified
Jul 2024
First submitted
22 Jan 2015
Last updated
27 Aug 2024
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37276510

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SGI-110 (guadecitabine) and Treatment Choice in people with Leukemia, Myeloid, Acute, run by Astex Pharmaceuticals, Inc. at 135 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Italy, France, South Korea, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Complete Response (CR) (time frame: Up to 38 months (median follow-up of 25.5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02348489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.

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