A Phase 1b Trial of Ivosidenib Combined With Ruxolitinib in IDH1-Mutated Advanced-Phase MPNs
University of Chicago
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 Ove…
Interventions
- DrugIvosidenib
Ivosidenib will be given at assigned dose once daily.
- DrugRuxolitinib
Ruxolitinib will be given at assigned dose twice daily.
Location
- University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois