Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia
Public ClinicalTrials.gov record NCT02920008. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) Versus Treatment Choice in Adults With Previously Treated Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine \[HiDAC\]; mitoxantrone, etoposide, and cytarabine \[MEC\]; or fludarabine, cytarabine, granulocyte colony stimulating factor \[G-CSF\], +/- idarubicin \[FLAG/FLAG-Ida\]). * Low intensity (low dose cytarabine \[LDAC\], decitabine, or azacitidine). * BSC.
Study identification
- NCT ID
- NCT02920008
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 302 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2017
- Primary completion
- Jan 19, 2020
- Completion
- May 31, 2020
- Last update posted
- Aug 27, 2024
2017 – 2020
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Franciscan Research Center | Indianapolis | Indiana | 46237 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601-1915 | — |
| University of New Mexico School of Medicine | Albuquerque | New Mexico | 87106 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104-5418 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19111-2433 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Research Institute | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| West Virginia University Hospitals, Inc. | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 80 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02920008, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02920008 live on ClinicalTrials.gov.