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Clinical trial

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)

NCT06465953 is registered in ClinicalTrials.gov with Institut de Recherches Internationales Servier as lead sponsor.

NCT NCT06465953
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Registry record

As filed in ClinicalTrials.gov.

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)
Lead sponsor
Institut de Recherches Internationales Servier
Phase
Phase 3
Overall status
Recruiting
Start date
December 3, 2024
Completion date
December 1, 2028
Enrollment
48 (estimated)
Sites
62

Conditions

As the registry lists them; a condition with its own page is linked.

hypomethylating agent (hma) naive myelodysplastic syndromes (mds), myelodysplastic syndromes (mds)