Condition: Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) · Myelodysplastic Syndromes (MDS) · Sponsor: Institut de Recherches Internationales Servier
This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.
This description comes directly from the study's public registry record.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department · +33 1 55 72 60 00 · scientificinformation@servier.com
Always discuss trial participation with your own doctor first.
| Presbyterian / St. Luke'S Medical Center | Denver, Colorado, United States | Not Yet Recruiting |
| University of Chicago, Duchossois Center for Advanced Medicine (DCAM) | Chicago, Illinois, United States | Recruiting |
| Massachusetts General Hospital | Boston, Massachusetts, United States | Recruiting |
| MSKCC | New York, New York, United States | Recruiting |
| Unc Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, United States | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus, Ohio, United States | Recruiting |
| Oncology Associates of Oregon | Eugene, Oregon, United States | Recruiting |
| University of Texas UT Southwestern Comprehensive Cancer Center | Dallas, Texas, United States | Not Yet Recruiting |
| MD Anderson Cancer Centre | Houston, Texas, United States | Recruiting |
| Royal Adelaide Hospital | Adelaide, Australia | Not Yet Recruiting |
| Monash Health | Clayton, Australia | Recruiting |
| Northern Health | Epping, Australia | Recruiting |
+ 50 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06465953