Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
Public ClinicalTrials.gov record NCT06465953. 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, Open Label, Randomized, Non-comparative Two-arm Study of Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Adult Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an Isocitrate Dehydrogenase-1 (IDH1) Mutation (PyramIDH Study)
Study identification
- NCT ID
- NCT06465953
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Institut de Recherches Internationales Servier
- Other
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Interventions
- Azacitidine Drug
- Ivosidenib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2, 2024
- Primary completion
- Oct 31, 2027
- Completion
- Nov 30, 2028
- Last update posted
- Apr 2, 2026
2024 – 2028
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Presbyterian / St. Luke'S Medical Center | Denver | Colorado | 80218 | Not yet recruiting |
| University of Chicago, Duchossois Center for Advanced Medicine (DCAM) | Chicago | Illinois | 60637 | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Recruiting |
| MSKCC | New York | New York | 10065 | Recruiting |
| Unc Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27514 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| Oncology Associates of Oregon | Eugene | Oregon | 97401 | Recruiting |
| University of Texas UT Southwestern Comprehensive Cancer Center | Dallas | Texas | 75235 | Not yet recruiting |
| MD Anderson Cancer Centre | Houston | Texas | 77030 | Recruiting |
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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06465953, 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 Apr 2, 2026 · Synced Apr 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06465953 live on ClinicalTrials.gov.