M.D. Anderson Cancer Center
To learn if olutasidenib, when combined with a drug called a hypomethylating agent (HMA) can help to control MDS, CMML, and/or MPN. The safety of the drug combination will also be studied.
Primary Objectives To determine the overall response rate of olutasidenib in combination with investigator's choice of HMA in patients with IDH1-mutated higher-risk MDS/CMML or advanced MPN Secondary Objectives The secondary objectives of this study are: * To evaluate the rates of complete remission (CR) and median duration of CR * To ascertain the safety and tolerability of olutasidenib with HMA in this participant population * To determine survival including overall survival (OS), progression-free survival (PFS), and duration of response (DOR) To analyze reduction in IDH1 clone size Explor…
Inclusion Criteria: 1. Pathologically proven higher-risk MDS/CMML or advanced MPN 1. MDS participants must have International Prognostic Scoring System (IPSS) intermediate-2- or high-risk disease or Revised IPSS (IPSS-R) score \>= 3.5 or Molecular IPSS (IPSS-M) moderate high-, high-, or very high-risk disease or bone marrow blast percentage. 2. CMML patients must have CPSS-Mol int-1, int-2, or high-ris disease (Elena C et al, Blood 2016) 3. Advanced MPN is defined as bone marrow blast percentage \>=/=10%. 4. Participants on the treatment-naive arm must not have received a prior H…
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