At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 815 enrolled
Drug / intervention
SGI-110 (guadecitabine) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SGI-110 (guadecitabine) and Treatment Choice for Leukemia, Myeloid, Acute. Completed, enrolled 815 participants across 135 sites in 24 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesAustralia, Austria, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Poland, Romania, Russia, Serbia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 2015
Enrollment StartMar 2015
Primary CompletionMay 2018
Study CompletionJun 2019
TodayJul 2026
First PostedJan 28, 2015
Enrollment StartMar 19, 2015
Primary CompletionMay 31, 2018
Study CompletionJun 17, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.4 years ago
Interventions
SGI-110 (guadecitabine)drug
Investigational medicinal product
Treatment Choicedrug
Choice of one: cytarabine, decitabine, or azacitidine