Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Bewersdorf J, Derkach A, Zeidan A, Stein E, Mauro M, Podoltsev N, Rampal R. Phase I Study of Ruxolitinib in Combination with Abemaciclib for Patients with Primary or Post-Polycythemia Vera/Essential Thrombocythemia Myelofibrosis. Blood 2024, 144: 6659-6659. DOI: 10.1182/blood-2024-194918.Peer-Reviewed Original ResearchDose-limiting toxicityCancer Institute Common Terminology Criteria for Adverse EventsTreatment-related adverse eventsAdverse eventsDose levelsCombination therapySpleen volumeInhibitor abemaciclibGrade 3Patients discontinued treatment due to adverse eventsNational Cancer Institute Common Terminology Criteria for Adverse EventsPhase I dose-escalation trialTreatment due to adverse eventsCommon Terminology Criteria for Adverse EventsDisease progressionRecommended phase II doseMulticenter Phase IPlanned dose levelsGrade 3 thrombocytopeniaMedian overall survivalPhase II doseBone marrow blastsBone marrow fibrosisClinically significant bleedingData cut-offPhase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in JAKi-naïve myelofibrosis.
Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Wang X, Kye S, Harrison C. Phase 3 randomized double-blind study evaluating selinexor, an XPO1 inhibitor, plus ruxolitinib in JAKi-naïve myelofibrosis. Journal Of Clinical Oncology 2024, 42: tps6594-tps6594. DOI: 10.1200/jco.2024.42.16_suppl.tps6594.Peer-Reviewed Original ResearchXPO1 inhibitorsIntent-to-treat populationCo-primary study endpointsBaseline platelet countTreatment-related AEsPlacebo-controlled studyStem cell transplantationPhase 1 portionPhase 3 trialYears of ageNausea prophylaxisOral selinexorIntermediate-1Intermediate-2Anemia responseMF patientsTreatment discontinuationDouble-blindCell transplantationMyeloproliferative neoplasmsSecondary endpointsPlatelet countSpleen volumeRuxolitinib treatmentIWG-MRT