To learn about the safety and tolerability of study drug combinations in patients with relapsed/refractory, IDH1-mutated myeloid malignancies with a co-signaling mutation.
Age ≥ 18 years.
Participants with a diagnosis of relapsed and/or refractory AML (including biphenotypic or bilineage leukemia including a myeloid component) OR high-risk MDS, MPN, or MDS/MPN (defined as ≥10% blasts on peripheral flow cytometry or bone marrow biopsy).
Participants must have a documented IDH1 mutation.
Participants must also have a documented co-signaling mutation in one or more of the following: KRAS, NRAS, PTPN11, CBL, NF1, FLT3-ITD, FLT3-TKD, KIT, JAK2, MPL, CALR, CSF3R.
Participants who have received prior olutasidenib (Rezlidhiai, previously FT-2102).
Participants with translocation t(15;17) or acute promyelocytic leukemia (French-American British (FAB) class M3-AML).
Participants with any concurrent uncontrolled clinically significant medical condition, including life threatening infection, which could place the patient at unacceptable risk of study treatment.
Participants with any uncontrolled psychiatric illness that would limit compliance with study requirements.
M.D. Anderson Cancer Center
Lead sponsor
Rigel Pharmaceuticals
Collaborator