Ivosidenib and Ruxolitinib in Patients With Advanced Myeloproliferative Neoplasms (MPNs) That Have an IDH1 Gene Mutation
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Advanced-Phase IDH1-mutated Ph-negative MPNs (both untreated and relapsed/refractory) including any of the following: * 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 * MPN-NOS with ≥ 5% peripheral or bone marrow blasts at time of screening * MDS/MPN Overlap Syndromes including CMML with ≥ 5% peripheral or bone marrow blasts at time of screening * post-PV myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening * post-ET myelofibrosis with ≥ 5% blasts peripheral or bone marrow blasts at time of screening * primary and secondary myelofibrosis with inadequate response to JAK inhibitor regardless of blast percentage. Inadequate respons