2024
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
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, 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
Phase 1b Study of the Epichaperome Inhibitor PU-H71 Administered Orally with Ruxolitinib Continuation for the Treatment of Patients with Myelofibrosis
Pemmaraju N, Gundabolu K, Pettit K, Talpaz M, Podoltsev N, Schiller G, Eisenberg P, Youssoufian H, Duggan S, Wallner B, Verstovsek S. Phase 1b Study of the Epichaperome Inhibitor PU-H71 Administered Orally with Ruxolitinib Continuation for the Treatment of Patients with Myelofibrosis. Blood 2019, 134: 4178. DOI: 10.1182/blood-2019-130310.Peer-Reviewed Original ResearchPhase 1b studyJazz PharmaceuticalsExpansion cohortPU-H71Daiichi SankyoMyeloproliferative Neoplasm Symptom Assessment Form Total Symptom ScoreInternational Working Group-Myeloproliferative Neoplasms ResearchPeripheral blood mononuclear cellsAdvisory CommitteeDose-expansion cohortsHigh-risk myelofibrosisPhase 2 doseSerum cytokine profilesBaseline platelet countDose-ranging studySpeakers bureauVentricular ejection fractionAST/ALTDose-escalation designTotal symptom scoreBlood mononuclear cellsDisease-related symptomsTreatment of patientsBone marrow histologyPost-PV myelofibrosis