PyramIDH: This study will enroll people with myelodysplastic syndromes (MDS) with an IDH1 mutation to evaluate the effectiveness of two different drugs (ivosidenib and azacitidine)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)

Trial purpose

Cancer treatment

Tumor type

Haematological

Age

18+

Trial acronym

PyramIDH

Summary

This trial is recruiting people with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation who have not received prior treatment with a hypomethylating agent.

Eligible participants will be randomised to receive either ivosidenib alone or azacitidine alone.

Ivosidenib will be given as two oral tablets daily throughout the 28-day treatment cycle, and azacitidine will be given by subcutaneous or intravenous (IV) injection 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 after that. After the last dose of treatment, participants will attend a 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

This trial is treating people with myelodysplastic syndromes (MDS) with IDH1 mutation