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

Primary Purpose

Leukemia, Myeloid, Acute

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SGI-110 (guadecitabine)
Treatment Choice
Sponsored by
Astex Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Arm Type

Experimental

Active Comparator

Arm Label

SGI-110 (guadecitabine)

Treatment Choice

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 22, 2015
Last Updated
December 21, 2020
Sponsor
Astex Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02348489
Brief Title
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
March 19, 2015 (Actual)
Primary Completion Date
May 31, 2018 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astex Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
AML, Acute Myeloid Leukemia, SGI-110, DNA Hypomethylating Agen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
815 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SGI-110 (guadecitabine)
Arm Type
Experimental
Arm Description
Guadecitabine 60 mg/m^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.
Arm Title
Treatment Choice
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SGI-110 (guadecitabine)
Intervention Description
Investigational medicinal product
Intervention Type
Drug
Intervention Name(s)
Treatment Choice
Intervention Description
Choice of one: cytarabine, decitabine, or azacitidine
Primary Outcome Measure Information:
Title
Number of Participants With a Complete Response (CR)
Description
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.
Time Frame
Up to 38 months (median follow-up of 25.5 months)
Title
Overall Survival
Description
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.
Time Frame
At 676 death events (up to 38 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Composite CR (CRc)
Description
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).
Time Frame
Up to 38 months (median follow-up of 25.5 months)
Title
Number of Days Alive and Out of the Hospital
Description
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.
Time Frame
Month 6
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Up to 38 months (median follow-up of 25.5 months)
Title
Number of Red Blood Cell or Platelet Transfusions
Description
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.
Time Frame
Month 6
Title
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Description
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.
Time Frame
Baseline to Month 6
Title
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Description
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.
Time Frame
Baseline to Month 6
Title
Duration of CR
Description
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.
Time Frame
Up to 38 months (median follow-up of 25.5 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Scripps Cancer Center
City
La Jolla
State/Province
California
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Hospitals Monarch Medical Center
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
State/Province
Styria
Country
Austria
Facility Name
Hanusch Krankenhaus Wiener Gebietskrankenkasse
City
Wien
State/Province
Vienna
Country
Austria
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
State/Province
Hainaut
ZIP/Postal Code
6061
Country
Belgium
Facility Name
UZ Gent
City
Ghent
State/Province
Oost-vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Jan
City
Brugge
State/Province
West-vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UMHAT 'Sveti Georgi' EAD
City
Plovdiv
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveta Marina'' EAD
City
Varna
Country
Bulgaria
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
76B 2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Fakultní nemocnice Brno
City
Brno
State/Province
Jihormoravsky KRAJ
Country
Czechia
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha 2
State/Province
Praha
Country
Czechia
Facility Name
Fakultní nemocnice Královské Vinohrady
City
Praha 10
ZIP/Postal Code
Praha 10
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Rigshospitalet-Copenhagen University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Southern Finland
Country
Finland
Facility Name
Helsinki University Central Hospital
City
Helsinki
Country
Finland
Facility Name
GHR Mulhouse Sud-Alsace
City
Mulhouse Cedex
State/Province
Alsace
Country
France
Facility Name
Hôpital Hôtel-Dieu
City
Bayonne
State/Province
Aquitaine
Country
France
Facility Name
Centre Henri-Becquerel
City
Rouen Cedex 1
State/Province
Haute-normandie
Country
France
Facility Name
Hôpital Saint Louis
City
Paris Cedex 10
State/Province
Ile-de-france
ZIP/Postal Code
75010
Country
France
Facility Name
CHRU de Limoges - Hôpital Dupuytren
City
Limoges Cedex
State/Province
Limousin, Lorraine
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse cedex 9
State/Province
Midi-pyrenees
Country
France
Facility Name
Hôpital Hôtel-Dieu
City
Nantes cedex 1
State/Province
PAYS DE LA Loire
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex 9
State/Province
Provence Alpes COTE D'azur
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
State/Province
Provence Alpes COTE D'azur
Country
France
Facility Name
Centre Hospitalier Universitaire Grenoble
City
La Tronche
State/Province
Rhone-alpes
ZIP/Postal Code
38700
Country
France
Facility Name
Centre Léon Bérard
City
Lyon Cedex 08
State/Province
Rhone-alpes
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
State/Province
Rhone-alpes
Country
France
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
City
Villingen-Schwenningen
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Universitätsklinikum Frankfurt Goethe Universität
City
Frankfurt am Main
State/Province
Hessen
Country
Germany
Facility Name
Städtisches Klinikum Braunschweig gGmbH
City
Braunschweig
State/Province
Niedersachsen
ZIP/Postal Code
38114
Country
Germany
Facility Name
Marien Hospital Düsseldorf GmbH
City
Düsseldorf
State/Province
Nordrhein-westfalen
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig-holstein
Country
Germany
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kecskemét
State/Province
Bacs-kiskun
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
State/Province
Pesaro E Urbino
Country
Italy
Facility Name
IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
City
Rionero in Vulture
State/Province
Potenza
Country
Italy
Facility Name
Azienda Ospedaliero-Univesitaria San Luigi Gonzaga
City
Orbassano
State/Province
Torino
Country
Italy
Facility Name
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria
City
Alessandria
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
City
Bologna
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale di Busto Arsizio
City
Busto Arsizio
ZIP/Postal Code
21052
Country
Italy
Facility Name
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino
City
Catania
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera Universitaria San Martino - IST
City
Genova
Country
Italy
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico di Modena
City
Modena
Country
Italy
Facility Name
AORN A. Cardarelli
City
Napoli
Country
Italy
Facility Name
Azienda Policlinico Umberto I di Roma
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine
City
Udine
Country
Italy
City
Chubu
Country
Japan
City
Chugoku
Country
Japan
City
Kanto
Country
Japan
City
Kinki
Country
Japan
City
Kyushu
Country
Japan
City
Tohoku
Country
Japan
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Jongno Gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Universitair Medisch Centrum Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
City
Wroclaw
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
City
Lódz
State/Province
Lodzkie
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
City
Lublin
State/Province
Lubelskie
Country
Poland
Facility Name
Instytut Hematologii i Transfuzjologii
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Samodzielny Publiczny Centralny Szpital Kliniczny
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Szpital Wojewódzki w Opolu - Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Opole
State/Province
Opolskie
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich
City
Chorzów
State/Province
Slaskie
Country
Poland
Facility Name
Spitalul Clinic Judetean de Urgenta Tirgu-Mures
City
Targu-Mures
State/Province
Mures
Country
Romania
Facility Name
Institutul Regional de Oncologie Iasi
City
Iasi
Country
Romania
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
Country
Russian Federation
Facility Name
Clinical Center of Serbia
City
Belgrade
Country
Serbia
Facility Name
Clinical Centre of Vojvodina
City
Novi Sad
Country
Serbia
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Vall d´Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital San Pedro de Alcantara
City
Caceres
Country
Spain
Facility Name
Hospital General Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clínico Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Skånes Universitetssjukhus i Lund
City
Lund
State/Province
Skane
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
Country
Sweden
Facility Name
Chang Gung Medical Foundation-LinKou Branch
City
Tao-Yuan
State/Province
Taoyuan
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
State/Province
England
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
England
Country
United Kingdom
Facility Name
Medway Maritime Hospital
City
Gillingham
State/Province
Kent
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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