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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02348489




Registration number
NCT02348489
Ethics application status
Date submitted
22/01/2015
Date registered
28/01/2015
Date last updated
27/08/2024

Titles & IDs
Public title
SGI-110 in Adults With Untreated Acute Myeloid Leukemia (AML), Not Considered Candidates for Intensive Remission Induction
Scientific 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
Secondary ID [1] 0 0
SGI-110-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SGI-110 (guadecitabine)
Treatment: Drugs - Treatment Choice

Experimental: SGI-110 (guadecitabine) - Guadecitabine 60 mg/m\^2 administered subcutaneously (SC) daily for 5 days (Days 1-5) in 28-day cycles.

Active comparator: Treatment Choice - 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.


Treatment: Drugs: SGI-110 (guadecitabine)
Investigational medicinal product

Treatment: Drugs: Treatment Choice
Choice of one: cytarabine, decitabine, or azacitidine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With a Complete Response (CR)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 38 months (median follow-up of 25.5 months)
Primary outcome [2] 0 0
Overall Survival
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
At 676 death events (up to 38 months)
Secondary outcome [1] 0 0
Number of Participants With Composite CR (CRc)
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
Up to 38 months (median follow-up of 25.5 months)
Secondary outcome [2] 0 0
Number of Days Alive and Out of the Hospital
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Month 6
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Up to 38 months (median follow-up of 25.5 months)
Secondary outcome [4] 0 0
Number of Red Blood Cell or Platelet Transfusions
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-5D-5L
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Baseline to Month 6
Secondary outcome [6] 0 0
Change in Health-related Quality of Life (QOL) Scores From Baseline: EQ-VAS
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Baseline to Month 6
Secondary outcome [7] 0 0
Duration of CR
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Up to 38 months (median follow-up of 25.5 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/06/2019
Sample size
Target
Accrual to date
Final
815
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New Mexico
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Austria
State/province [15] 0 0
Styria
Country [16] 0 0
Austria
State/province [16] 0 0
Vienna
Country [17] 0 0
Belgium
State/province [17] 0 0
Hainaut
Country [18] 0 0
Belgium
State/province [18] 0 0
Oost-vlaanderen
Country [19] 0 0
Belgium
State/province [19] 0 0
West-vlaanderen
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Plovdiv
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Varna
Country [22] 0 0
Canada
State/province [22] 0 0
Alberta
Country [23] 0 0
Canada
State/province [23] 0 0
British Columbia
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Czechia
State/province [25] 0 0
Jihormoravsky KRAJ
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha
Country [27] 0 0
Czechia
State/province [27] 0 0
Praha 10
Country [28] 0 0
Denmark
State/province [28] 0 0
Aarhus
Country [29] 0 0
Denmark
State/province [29] 0 0
Copenhagen
Country [30] 0 0
Denmark
State/province [30] 0 0
Odense
Country [31] 0 0
Finland
State/province [31] 0 0
Southern Finland
Country [32] 0 0
Finland
State/province [32] 0 0
Helsinki
Country [33] 0 0
France
State/province [33] 0 0
Alsace
Country [34] 0 0
France
State/province [34] 0 0
Aquitaine
Country [35] 0 0
France
State/province [35] 0 0
Haute-normandie
Country [36] 0 0
France
State/province [36] 0 0
Ile-de-france
Country [37] 0 0
France
State/province [37] 0 0
Limousin, Lorraine
Country [38] 0 0
France
State/province [38] 0 0
Midi-pyrenees
Country [39] 0 0
France
State/province [39] 0 0
PAYS DE LA Loire
Country [40] 0 0
France
State/province [40] 0 0
Provence Alpes COTE D'azur
Country [41] 0 0
France
State/province [41] 0 0
Rhone-alpes
Country [42] 0 0
Germany
State/province [42] 0 0
Baden-wuerttemberg
Country [43] 0 0
Germany
State/province [43] 0 0
Hessen
Country [44] 0 0
Germany
State/province [44] 0 0
Niedersachsen
Country [45] 0 0
Germany
State/province [45] 0 0
Nordrhein-westfalen
Country [46] 0 0
Germany
State/province [46] 0 0
Schleswig-holstein
Country [47] 0 0
Hungary
State/province [47] 0 0
Bacs-kiskun
Country [48] 0 0
Hungary
State/province [48] 0 0
Budapest
Country [49] 0 0
Hungary
State/province [49] 0 0
Debrecen
Country [50] 0 0
Hungary
State/province [50] 0 0
Kaposvár
Country [51] 0 0
Italy
State/province [51] 0 0
Pesaro E Urbino
Country [52] 0 0
Italy
State/province [52] 0 0
Potenza
Country [53] 0 0
Italy
State/province [53] 0 0
Torino
Country [54] 0 0
Italy
State/province [54] 0 0
Alessandria
Country [55] 0 0
Italy
State/province [55] 0 0
Bologna
Country [56] 0 0
Italy
State/province [56] 0 0
Busto Arsizio
Country [57] 0 0
Italy
State/province [57] 0 0
Catania
Country [58] 0 0
Italy
State/province [58] 0 0
Genova
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Modena
Country [61] 0 0
Italy
State/province [61] 0 0
Napoli
Country [62] 0 0
Italy
State/province [62] 0 0
Roma
Country [63] 0 0
Italy
State/province [63] 0 0
Udine
Country [64] 0 0
Japan
State/province [64] 0 0
Chubu
Country [65] 0 0
Japan
State/province [65] 0 0
Chugoku
Country [66] 0 0
Japan
State/province [66] 0 0
Kanto
Country [67] 0 0
Japan
State/province [67] 0 0
Kinki
Country [68] 0 0
Japan
State/province [68] 0 0
Kyushu
Country [69] 0 0
Japan
State/province [69] 0 0
Tohoku
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Gyeonggi-do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Jeollanam-do
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Seoul
Country [73] 0 0
Korea, Republic of
State/province [73] 0 0
Busan
Country [74] 0 0
Korea, Republic of
State/province [74] 0 0
Daegu
Country [75] 0 0
Korea, Republic of
State/province [75] 0 0
Ulsan
Country [76] 0 0
Netherlands
State/province [76] 0 0
Utrecht
Country [77] 0 0
Poland
State/province [77] 0 0
Dolnoslaskie
Country [78] 0 0
Poland
State/province [78] 0 0
Lodzkie
Country [79] 0 0
Poland
State/province [79] 0 0
Lubelskie
Country [80] 0 0
Poland
State/province [80] 0 0
Mazowieckie
Country [81] 0 0
Poland
State/province [81] 0 0
Opolskie
Country [82] 0 0
Poland
State/province [82] 0 0
Slaskie
Country [83] 0 0
Romania
State/province [83] 0 0
Mures
Country [84] 0 0
Romania
State/province [84] 0 0
Iasi
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Ekaterinburg
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Ryazan
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Saratov
Country [88] 0 0
Serbia
State/province [88] 0 0
Belgrade
Country [89] 0 0
Serbia
State/province [89] 0 0
Novi Sad
Country [90] 0 0
Spain
State/province [90] 0 0
Asturias
Country [91] 0 0
Spain
State/province [91] 0 0
Barcelona
Country [92] 0 0
Spain
State/province [92] 0 0
Caceres
Country [93] 0 0
Spain
State/province [93] 0 0
Granada
Country [94] 0 0
Spain
State/province [94] 0 0
Madrid
Country [95] 0 0
Spain
State/province [95] 0 0
Salamanca
Country [96] 0 0
Spain
State/province [96] 0 0
Sevilla
Country [97] 0 0
Spain
State/province [97] 0 0
Valencia
Country [98] 0 0
Sweden
State/province [98] 0 0
Skane
Country [99] 0 0
Sweden
State/province [99] 0 0
Stockholm
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taoyuan
Country [101] 0 0
Taiwan
State/province [101] 0 0
Taichung
Country [102] 0 0
Taiwan
State/province [102] 0 0
Taipei
Country [103] 0 0
United Kingdom
State/province [103] 0 0
England
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Kent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astex Pharmaceuticals, Inc.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02348489