A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.

Inclusion Criteria: Pathologically proven CCUS or lower-risk MDS/CMML. CCUS is defined as the presence of cytopenia (absolute neutrophil count < 1.8 x 109 10^9/L, hemoglobin < 13 g/dL in males or < 12 g/dL in females, and/or platelets < 150 x 109 10^9/L) for at least 30 days that are otherwise unexplained and with no diagnostic hematopathologic features of myeloid neoplasms7 neoplasms. Patients with known Duffy-null phenotype must have absolut [...] limit of normal. Lower-risk MDS/CMML includes patients with International Prognostic Scoring System (IPSS) low- or intermediate-1-risk disease and Revis [...] [...]

[...] ictors of antitumor activity and/or resistance to treatment. OUTLINE: Patients receive olutasidenib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with CCUS receive up to 18 months of olutasidenib. Patients with lower-risk MDS/CMML can receive olut [...]

[...] and with no diagnostic hematopathologic features of myeloid neoplasmsneoplasms7 . Patients with known Duffy-null phenotype must have absolute neutrophil counts less than their lower limit of normal. Lower-risk MDS/CMML includes patients with International Prognostic Scoring System (IPSS) low- or intermediate-1-risk disease and Revised IPSS (IPSS-R) score ≤ 3.5 and Molecular IPSS (IPSS-M) very low-, low-, or moderate low-risk categoriescategories28,29,34.v ParticipantsPatients must have a documented IDH1 mutation with VAF ≥ 0.02 ParticipantsPatients ≥ 18 years old Eastern Cooperative Oncology G [...] [...]

A Phase 2 Study Evaluating Olutasidenib in Patients withWith IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/syndromesSyndromes/chronicChronic Myelomonocytic Leukemia.