EICHORCondition: Myelodysplastic Syndromes · Sponsor: Geron Corporation
The purpose of this study is to evaluate the efficacy and safety of imetelstat sodium in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Phase 2 study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat sodium to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Phase 3 study. A separate Ventricular Repolarization Substudy (QTc Substudy) will evaluate the effect of imetelstat sodium on ventricular repolarization. An Extension Phase has been included to allow continued treatment for those participants who are benefitting from imetelstat sodium and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| UAB Comprehensive Cancer Center | Birmingham, Alabama, United States | — |
| Acrc/Arizona Clinical Research, Inc. | Tucson, Arizona, United States | — |
| CBCC Global Research, Inc. | Bakersfield, California, United States | — |
| UCLA Ronald Regan Medical Center | Los Angeles, California, United States | — |
| Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital | New Haven, Connecticut, United States | — |
| BRCR Medical Center | Plantation, Florida, United States | — |
| University of South Florida (USF) - H. Lee Moffitt Cancer Center | Tampa, Florida, United States | — |
| Franciscan Health | Indianapolis, Indiana, United States | — |
| St. Agnes Healthcare, Inc | Baltimore, Maryland, United States | — |
| Center for Cancer and Blood Disorders | Bethesda, Maryland, United States | — |
| Washington University School of Medicine | St Louis, Missouri, United States | — |
| University of New Mexico Cancer Center | Albuquerque, New Mexico, United States | — |
+ 114 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT02598661