The purpose of this research is to gather information on the safety and effectiveness determining maximum tolerated dose (MTD) of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs while evaluate the efficacy of ruxolitinib in combination with ivosidenib in IDH1-mutated advanced-phase Ph-negative MPNs.
polycythemia vera with (PV) ≥ 5% peripheral or bone marrow blasts at time of screening
essential thrombocythemia (ET) with ≥ 5% peripheral or bone marrow blasts at time of screening
primary myelofibrosis (PMF) with ≥ 5% peripheral or bone marrow blasts at time of screening
Atypical CML with ≥ 5% peripheral or bone marrow blasts at time of screening
Patients cannot be on concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in this protocol. Patients cannot have had prior treatment with ivosidenib.
Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease or they are not currently requiring treatment for an indolent malignancy. Patients with APL and active CNS disease would also be excluded
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivosidenib or ruxolitinib.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, venous thromboembolism, stroke, active chronic liver disease (eg chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cholangitis, hemochromatosis) or psychiatric illness/social situations that would limit compliance with study requirements.
Sequential
Ivosidenib
DrugIvosidenib will be given at assigned dose once daily.
Ruxolitinib
DrugRuxolitinib will be given at assigned dose twice daily.
Maximum tolerated dose
The highest dose of a drug or treatment that does not cause unacceptable side effects.
Overall Survival (OS)
Percentage of participants still alive after 5 years.
Overall Response Rate (ORR)
Percentage of participants that meet protocol defined criteria for response to study treatments.
Time to Response (TTR)
Time from treatment administration to first documented response.
Duration of response (DOR)
Time from achieving a response until disease progression, relapse, or death.
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