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NCT06465953 · ClinicalTrials.gov registry record · Phase 3
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
A Phase 3 study of Myelodysplastic Syndromes (MDS) and Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), sponsored by Institut de Recherches Internationales Servier.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 48
- Enrollment target
- 20
- Study locations
NCT06465953: Recruiting Phase 3 study of Myelodysplastic Syndromes (MDS) and Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), sponsored by Institut de Recherches Internationales Servier.
NCT06465953 is a Phase 3 study of Myelodysplastic Syndromes (MDS) and Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) that is actively recruiting participants, run by Institut de Recherches Internationales Servier. The registered enrollment target is 48 participants, below the 185-participant average among 10 other Myelodysplastic Syndromes (MDS) trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06465953, a Phase 3 study of Myelodysplastic Syndromes (MDS) and Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS), is actively recruiting participants, sponsored by Institut de Recherches Internationales Servier.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 48 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Complete remission (CR) or Partial remission (PR) as per International Working Group (IWG) 2006 criteria
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 |
What NCT06465953 shows while recruiting
NCT06465953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 185-participant average among 10 other Myelodysplastic Syndromes (MDS) trials with a reported enrollment target (74% lower).
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.
NCT06465953 names 20 study sites across 9 states, led by Other, Texas, Colorado.
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).
What interventions are being tested in trial NCT06465953?
The interventions under investigation include: Azacitidine (DRUG), Ivosidenib (DRUG).
Who is sponsoring clinical trial NCT06465953?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06465953's enrollment target sits among peer trials
48 10th of 10 higher than 1 of 10 other Myelodysplastic Syndromes (MDS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes (MDS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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