2023
Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies
Kontro M, Stein A, Pyörälä M, Rimpiläinen J, Siitonen T, Hollmén M, Fjaellskog M, Pawlitzky I, Zeidan A, Daver N. Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies. Blood 2023, 142: 2915. DOI: 10.1182/blood-2023-174912.Peer-Reviewed Original ResearchAcute myeloid leukemiaR AMLCLEVER-1Complete remissionStandard of careBex treatmentAdverse eventsBone marrow cellsHMA failureMarrow CRPatient BMPrior therapyPartial remissionAML patientsMedian numberT cellsDose levelsMyeloid malignanciesHigh-risk MDS patientsMarrow cellsMarrow complete remissionR AML patientsRisk MDS patientsNK cell numbersPhase 1/2 study
2020
Blast MRD CML 1 Trial: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MRD) in Chronic Myeloid Leukemia (CML)- a Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease: A Trial of the ECOG-ACRIN Cancer Research Group (EA9171)
Zeidan A, Wang V, Radich J, Bewersdorf J, Bhatt V, Sharon E, Gore S, Luger S, Litzow M. Blast MRD CML 1 Trial: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MRD) in Chronic Myeloid Leukemia (CML)- a Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease: A Trial of the ECOG-ACRIN Cancer Research Group (EA9171). Blood 2020, 136: 1. DOI: 10.1182/blood-2020-137734.Peer-Reviewed Original ResearchUndetectable minimal residual diseaseChronic myeloid leukemiaMeasurable residual diseaseTyrosine kinase inhibitorsTKI discontinuationTKI therapyMinimal residual diseaseCML patientsResidual diseaseMyeloid leukemiaBristol-Myers SquibbPembrolizumab therapyAdverse eventsPD-1T cellsCML cellsAnti-PD-1/PD-L1 therapyBlast phase chronic myeloid leukemiaPilot phase II clinical trialThird-line tyrosine kinase inhibitorsAllogeneic hematopoietic stem cell transplantAnti-PD-1 monoclonal antibodyPD-1/PD-L1Anti-PD-1 pembrolizumabDetectable minimal residual disease
2019
Pharmacodynamic Responses to CC-90009, a Novel Cereblon E3 Ligase Modulator, in a Phase I Dose-Escalation Study in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
Fan J, Wang H, Couto S, Yao T, Uy G, Zeidan A, Minden M, Montesinos P, DeAngelo D, Altman J, Koprivnikar J, Vyas P, Fløisand Y, Vidriales M, Gjertsen B, Buchholz T, Pourdehnad M, Pierce D. Pharmacodynamic Responses to CC-90009, a Novel Cereblon E3 Ligase Modulator, in a Phase I Dose-Escalation Study in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML). Blood 2019, 134: 2547. DOI: 10.1182/blood-2019-124291.Peer-Reviewed Original ResearchNovel cereblon E3 ligase modulatorCereblon E3 ligase modulatorPeripheral blood mononuclear cellsCC-90009T cellsPharmacodynamic responseCelgene CorporationDaiichi SankyoSpeakers bureauR AMLAML blastsIntegrated stress responseBlast cellsDay 1Dose levelsPhase I dose-escalation studyRefractory acute myeloid leukemiaI dose-escalation studyAdvisory CommitteeBone marrow core biopsiesAntileukemic activitySeattle GeneticsPhase IHigh-dose cohortNorwegian Cancer SocietyWill deeper characterization of the landscape of immune checkpoint molecules in acute myeloid leukemia bone marrow lead to improved therapeutic targeting?
Vandsemb EN, Kim TK, Zeidan AM. Will deeper characterization of the landscape of immune checkpoint molecules in acute myeloid leukemia bone marrow lead to improved therapeutic targeting? Cancer 2019, 125: 1410-1413. PMID: 30861094, PMCID: PMC6467744, DOI: 10.1002/cncr.32042.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements
2018
Effective Immunomodulation with Pomalidomide Beginning at Early Lymphocyte Recovery during Induction Timed Sequential Therapy (TST) for Acute Myeloid Leukemia (AML) and High-Risk Myelodysplasia (HR-MDS)
Zeidner J, Knaus H, Zeidan A, Blackford A, Montiel-Esparza R, Prince G, Gondek L, Ghiaur G, Showel M, DeZern A, Pratz K, Smith B, Levis M, Foster M, Coombs C, Streicher H, Karp J, Luznik L, Gojo I. Effective Immunomodulation with Pomalidomide Beginning at Early Lymphocyte Recovery during Induction Timed Sequential Therapy (TST) for Acute Myeloid Leukemia (AML) and High-Risk Myelodysplasia (HR-MDS). Blood 2018, 132: 335. DOI: 10.1182/blood-2018-99-114961.Peer-Reviewed Original ResearchEarly lymphocyte recoveryTimed sequential therapyAcute myeloid leukemiaMinimal residual diseaseT cellsLymphocyte recoveryCR rateMedian timeDay 1Phase 1 dose-escalation studyALT/AST elevationsAcute respiratory distress syndromeSecondary acute myeloid leukemiaAdverse-risk cytogeneticsHR-MDS patientsNon-hematologic gradePoor-risk subsetStandard induction therapyAcute kidney injuryMedian overall survivalPeripheral blood CD4Disease-free survivalDose-escalation studyEvent-free survivalGrade 3 rashA Multi-center Phase I Trial of Ipilimumab in Patients with Myelodysplastic Syndromes following Hypomethylating Agent Failure
Zeidan AM, Knaus HA, Robinson TM, Towlerton AMH, Warren EH, Zeidner JF, Blackford AL, Duffield AS, Rizzieri D, Frattini MG, Levy YM, Schroeder MA, Ferguson A, Sheldon KE, DeZern AE, Gojo I, Gore SD, Streicher H, Luznik L, Smith BD. A Multi-center Phase I Trial of Ipilimumab in Patients with Myelodysplastic Syndromes following Hypomethylating Agent Failure. Clinical Cancer Research 2018, 24: 3519-3527. PMID: 29716921, PMCID: PMC6680246, DOI: 10.1158/1078-0432.ccr-17-3763.Peer-Reviewed Original ResearchConceptsImmune-related adverse eventsMarrow complete responseMyelodysplastic syndromeGrade 2T cellsHigher immune-related adverse eventsHigh-risk myelodysplastic syndromeT-cell receptor sequencingRisk myelodysplastic syndromesInvestigator-initiated trialClin Cancer ResDrug discontinuationHMA failureStable diseaseSystemic steroidsAdverse eventsMedian survivalComplete responseDismal survivalAdditional patientsClinical benefitTreatment optionsExcessive toxicityPatientsDose levels
2016
Phase 1 Study of Pomalidomide Given at the Time of Early Lymphocyte Recovery after Induction Timed Sequential Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HR-MDS)
Zeidner J, Montiel-Esparza R, Knaus H, Berglund S, Zeidan A, McCurdy S, Prince G, Gondek L, Ghiaur G, Showel M, DeZern A, Pratz K, Smith B, Levis M, Foster M, Jamieson K, Van Deventer H, Streicher H, Karp J, Luznik L, Gojo I. Phase 1 Study of Pomalidomide Given at the Time of Early Lymphocyte Recovery after Induction Timed Sequential Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HR-MDS). Blood 2016, 128: 2820. DOI: 10.1182/blood.v128.22.2820.2820.Peer-Reviewed Original ResearchEarly lymphocyte recoveryAcute myeloid leukemiaWhite blood cell countComplete remissionAdverse eventsT cellsLymphocyte recoveryDay 1Adverse-risk acute myeloid leukaemiaDose levelsALT increasePhase 1 dose-escalation studyAST/ALT increaseContinuous infusion days 1High-risk myelodysplastic syndromeCore-binding factor acute myeloid leukemiaTotal white blood cell countFlow cytometryFactor acute myeloid leukemiaFull recoveryGrade 3 hypoxiaIncomplete platelet recoveryInfusion days 1Common adverse eventsConventional chemotherapy regimens