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Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
NCT06465953 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Ivosidenib
Study Locations (20)
Other
- Royal Adelaide Hospital — Adelaide
- Monash Health — Clayton
- Northern Health — Epping
- Liverpool Hospital — Liverpool
- Sir Charles Gairdner Hospital — Nedlands
- Calvary Mater Newcastle — Waratah
- Liga Paranaense de Combate ao Câncer - Hospital Erasto Gaertner — Curitiba
- Centro de Pesquisa Clínica - Hospital Nove de Julho — São Paulo
- Real E Benemérita Associação Portuguesa de São Paulo — São Paulo
- Hospital das Clínicas da Faculdade de Medicina da USP — São Paulo
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo
Texas
- University of Texas UT Southwestern Comprehensive Cancer Center — Dallas
- MD Anderson Cancer Centre — Houston
Colorado
- Presbyterian / St. Luke'S Medical Center — Denver
Illinois
- University of Chicago, Duchossois Center for Advanced Medicine (DCAM) — Chicago
Massachusetts
- Massachusetts General Hospital — Boston
New York
- MSKCC — New York
North Carolina
- Unc Lineberger Comprehensive Cancer Center — Chapel Hill
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2024-12-03 |
| Est. Completion | 2028-12-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06465953
The ClinicalTrials.gov registry entry for NCT06465953 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Institut de Recherches Internationales Servier, which has 16 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Myelodysplastic Syndromes (MDS) appearing as the primary indexed condition, and to 2 interventions — of which Azacitidine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06465953 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Texas, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06465953 about?
NCT06465953 is a clinical study titled "Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation". 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)...
What is the current status of trial NCT06465953?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2024-12-03. Estimated completion is 2028-12-01.
What conditions does trial NCT06465953 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes (MDS), Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06465953?
The interventions under investigation include: Azacitidine (DRUG), Ivosidenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06465953?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 16 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06465953 being conducted?
This trial has 20 study locations across Colorado, Illinois, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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