Guadecitabine (SGI-110) vs Treatment Choice in Adults With MDS or CMML Previously Treated With HMAs
Public ClinicalTrials.gov record NCT02907359. 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 Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated With Hypomethylating Agents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase 3, randomized, open-label, parallel-group, multicenter study designed to evaluate the efficacy and safety of guadecitabine in participants with MDS or CMML who failed or relapsed after adequate prior treatment with azacitidine, decitabine, or both. This global study will be conducted in approximately 15 countries. Approximately 408 participants from approximately 100 study centers will be randomly assigned in a 2:1 ratio to either guadecitabine (approximately 272 participants) or Treatment Choice (approximately 136 participants). The study consists of a 21-day screening period, a treatment period, a safety follow-up visit, and a long-term follow-up period. The study is expected to last more than 2 years, and the duration of individual participant participation will vary. Participants may continue to receive treatment for as long as they continue to benefit.
Study identification
- NCT ID
- NCT02907359
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 417 participants
Conditions and interventions
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
- Jan 13, 2017 (Actual)
- Primary completion
- Mar 31, 2020 (Actual)
- Completion
- Nov 30, 2020 (Actual)
- Last update posted
- Aug 27, 2024
2017 – 2020
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California | 92270 | — |
| Cancer Specialists of North Florida | Fleming Island | Florida | 32003 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| North Shore Medical Center | Evanston | Illinois | 60201 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | — |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | — |
| Duke Cancer Center | Durham | North Carolina | 27705 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Bon Secours Saint Francis Hospital | Greenville | South Carolina | 29607 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| West Virginia University Mary Babb Randolph Cancer Center | 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 90 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02907359, 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 Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02907359 live on ClinicalTrials.gov.