2025
Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design
Mascarenhas J, Maher K, Rampal R, Bose P, Podoltsev N, Hong J, Chai Y, Kye S, Method M, Harrison C, . Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design. Future Oncology 2025, 21: 807-813. PMID: 39911057, PMCID: PMC11916360, DOI: 10.1080/14796694.2025.2461393.Peer-Reviewed Original ResearchConceptsJAK inhibitorsNo dose limiting toxicitiesDose-limiting toxicityAbsolute mean changeSpleen volume reductionPlacebo-controlled studyBaseline to weekTreatment of patientsDose expansionDose escalationLimiting toxicitiesDouble-blindPrimary endpointPhase 3 study designXPO1 inhibitorsMean changeRuxolitinibPatientsSelinexorVolume reductionDosePhase 3InhibitorsJAKMyelofibrosis
2024
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-offEfficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2)
Stempel J, Uy G, Dinner S, Gojo I, Reed D, Roy R, Byrd K, Yerrabothala S, Lai C, Doucette K, Caldwell A, Blaha O, Podoltsev N, Mendez L, Bewersdorf J, Kewan T, Wistuba I, Alatrash G, Haymaker C, Streicher H, Sharon E, Little R, Gore S, Radich J, Wood B, Zeidan A, Shallis R. Efficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2). Blood 2024, 144: 736. DOI: 10.1182/blood-2024-210370.Peer-Reviewed Original ResearchPhase II trialTreatment-related AEsII trialFrequent treatment-related AEsSafety run-in periodAllogeneic stem cell transplantationNo dose limiting toxicitiesRandomized phase II trialAML-2Multi-centerControl armSafety of pembrolizumabDose-limiting toxicityPD-1 inhibitionAnti-PD1 antibodyIncomplete count recoveryFLT3 wild-typeIntermediate cytogenetic riskStem cell transplantationAcute myeloid leukemiaActivated T cellsRun-in periodIntention-to-treat analysisCancer Immune MonitoringLong-term survivalA phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B‐cell or T‐cell acute lymphoblastic leukemia: Results from the ECOG‐ACRIN EA9152 protocol
Palmisiano N, Lee J, Claxton D, Paietta E, Alkhateeb H, Park J, Podoltsev N, Atallah E, Schaar D, Dinner S, Webster J, Luger S, Litzow M. A phase 1 trial of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory B‐cell or T‐cell acute lymphoblastic leukemia: Results from the ECOG‐ACRIN EA9152 protocol. EJHaem 2024, 5: 951-956. PMID: 39415930, PMCID: PMC11474352, DOI: 10.1002/jha2.991.Peer-Reviewed Original ResearchAcute lymphoblastic leukemiaMaximum tolerated doseT-cell acute lymphoblastic leukemiaLymphoblastic lymphomaLymphoblastic leukemiaTreatment-related adverse eventsDose level 3MRD-negative responseDose level 2Dose-limiting toxicityPhase I portionDose-escalation designPhase I/II trialPhase 1 trialPhase I objectivesPhase 2 portionAcute lymphoblastic leukemia subjectsEscalation designTolerated doseLiposomal vincristinePreclinical dataTherapeutic challengeEfficacy outcomesT cellsT-ALL
2023
A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents
Bewersdorf J, Shallis R, Sharon E, Park S, Ramaswamy R, Roe C, Irish J, Caldwell A, Wei W, Yacoub A, Madanat Y, Zeidner J, Altman J, Odenike O, Yerrabothala S, Kovacsovics T, Podoltsev N, Halene S, Little R, Piekarz R, Gore S, Kim T, Zeidan A. A multicenter phase Ib trial of the histone deacetylase inhibitor entinostat in combination with pembrolizumab in patients with myelodysplastic syndromes/neoplasms or acute myeloid leukemia refractory to hypomethylating agents. Annals Of Hematology 2023, 103: 105-116. PMID: 38036712, PMCID: PMC11838822, DOI: 10.1007/s00277-023-05552-4.Peer-Reviewed Original ResearchConceptsDose-limiting toxicityAcute myeloid leukemiaMarrow complete remissionPhase Ib trialAdverse eventsIb trialDose escalationNCI Cancer Therapy Evaluation ProgramAcute myeloid leukemia refractoryHematologic adverse eventsProtocol-defined responseDose level 1Anti-PD1 therapyAnti-PD1 antibodyDose-escalation designLimited clinical efficacySystems immunology approachHistone deacetylase inhibitor entinostatLeukemia refractoryMCR patientsComplete remissionRespiratory failureSuppressor cellsEscalation designClinical efficacy
2019
PS1036 UPDATED RESULTS FROM A PHASE 1 STUDY OF GILTERITINIB IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED AML
Pratz K, Cherry M, Altman J, Cooper B, Cruz J, Jurcic J, Levis M, Lin T, Perl A, Podoltsev N, Schiller G, Liu C, Bahceci E. PS1036 UPDATED RESULTS FROM A PHASE 1 STUDY OF GILTERITINIB IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED AML. HemaSphere 2019, 3: 468. DOI: 10.1097/01.hs9.0000562440.81745.10.Peer-Reviewed Original ResearchPhase 1 studyMaintenance therapyAdverse eventsConsolidation chemotherapyExpansion doseFebrile neutropeniaSerious drug-related adverse eventsComposite complete remission rateSingle-agent maintenance therapyDrug-related adverse eventsWhite blood cell countMedian overall survivalSafety/tolerabilityComplete remission rateFront-line chemotherapyDose-limiting toxicitySmall intestinal obstructionBlood cell countCycles of inductionHigh response rateCRC ratesIdarubicin inductionDose expansionIntestinal obstructionOverall survival
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