Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

Inclusion Criteria

• •Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):
• •Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.
• •Low and moderate low-risk MDS per IPSS-M score must:
• •Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND
• •Have a blast count between 5-19% AND
• •Be eligible for HMA therapy (very low risk participants are to be excluded)
• •Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation