A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic/Syndromes/Chronic Myelomonocytic Leukemia.
M.D. Anderson Cancer Center
Summary
To learn if olutasidenib can help to control CCUS, MDS, and/or CMML. The safety of the drug will also be studied.
Description
Primary Objectives - To determine the response rate of olutasidenib monotherapy in patients with IDH1-mutated CCUS or lower-risk MDS/CMML Secondary Objectives * To evaluate the rates of transfusion independence, defined as the absence of transfusions over a period of at least 8 weeks * To ascertain the safety and tolerability of olutasidenib monotherapy in these participants populations * To determine survival and rates of leukemia transformation * To analyze reduction in IDH1 clone size Exploratory Objectives \- To investigate global gene expression profiles, DNA methylation profiles, and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Pathologically proven CCUS or lower-risk MDS/CMML. 1. CCUS is defined as the presence of cytopenia (absolute neutrophil count \< 1.8 x 10\^9/L, hemoglobin \< 13 g/dL in males or \< 12 g/dL in females, and/or platelets \< 150 x 10\^9/L) for at least 30 days that are otherwise unexplained and with no diagnostic hematopathologic features of myeloid neoplasms. Patients with known Duffy-null phenotype must have absolute neutrophil counts less than their lower limit of normal. 2. Lower-risk MDS/CMML includes patients with International Prognostic Scoring System (IPSS)…
Interventions
- DrugOlutasidenib
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas