Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
Public ClinicalTrials.gov record NCT01241500. 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
Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
Study identification
- NCT ID
- NCT01241500
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 299 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
- Nov 2010 (Actual)
- Primary completion
- Oct 3, 2018 (Actual)
- Completion
- Oct 3, 2018 (Actual)
- Last update posted
- Jun 30, 2020
2010 – 2018
United States locations
- U.S. sites
- 41
- U.S. states
- 22
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Virginia G. Piper Cancer Center | Scottsdale | Arizona | 85258 | — |
| University of California San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Stanford Cancer Center | Stanford | California | 94305 | — |
| Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | — |
| Integrated Community Oncology Network | Jacksonville | Florida | 32256 | — |
| Innovative Medical Research of South Florida, Inc. | Miami | Florida | 33169 | — |
| Mount Sinai Comprehensive Cancer Centers | Miami Beach | Florida | 33140 | — |
| Woodlands Medical Specialists | Pensacola | Florida | 32503 | — |
| Martin Memorial Cancer Center | Stuart | Florida | 34994 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Emory University Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| North Shore Medical Center | Evanston | Illinois | 60201 | — |
| Cardinal Bernardin Cancer Center | Maywood | Illinois | 60153 | — |
| Edward H. Kaplan MD & Associates | Skokie | Illinois | 60076 | — |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | — |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | — |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Providence Cancer Center | Southfield | Michigan | 48075 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Overlook Hospital | Summit | New Jersey | 07901 | — |
| North Shore - LIJ Health System | Lake Success | New York | 11042 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Bon Secours St. Francois Health System | Greenville | South Carolina | 29601 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| University of Texas M. D. Anderson Cancer Center | Houston | Texas | 77030 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78229 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01241500, 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 Jun 30, 2020 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01241500 live on ClinicalTrials.gov.