2025
Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia
Pyzer A, Dillon L, Sharon E, Karrison T, Zha Y, Fulton N, Gui G, Andrew G, Streicher H, Sweet K, Yaghmour G, Liu J, Jonas B, Schimmer A, Grant S, Zeidan A, Hildebrandt G, Lowrey C, Mattison R, Palmisiano N, Salhotra A, Tzachanis D, Baer M, Lin T, Patel P, Chen H, Stadler W, Odenike O, Larson R, Gajewski T, Hourigan C, Stock W, Liu H. Randomized phase 2 study to assess the role of single-agent nivolumab to maintain remission in acute myeloid leukemia. Blood Advances 2025, 9: 2144-2152. PMID: 39928953, PMCID: PMC12051614, DOI: 10.1182/bloodadvances.2024015176.Peer-Reviewed Original ResearchRandomized phase II studyProgression-free survivalPhase II studyNivolumab armAdverse eventsObservation armOverall survivalII studyMedian duration of follow-upProgression-free survival curvesDuration of follow-upEfficacy of nivolumabIncomplete hematologic recoverySingle-agent nivolumabEvaluation of adverse eventsAcute myeloid leukemiaIncreased AEsAML chemotherapyMedian OSNivolumab administrationNivolumab maintenanceHematologic recoveryDisease relapseOpen-labelMedian duration
2024
Impact of Response to Hypomethylating Agent-Based Therapy on Survival Outcomes in the Context of Baseline Clinical-Molecular Risk and Transplant Status in Patients with Myelodysplastic Syndromes/Neoplasms (MDS): An Analysis from the International Consortium for MDS (icMDS) Validate Database
Rolles B, Bewersdorf J, Kewan T, Blaha O, Stempel J, Lanino L, Al Ali N, DeZern A, Sekeres M, Uy G, Carraway H, Desai P, Griffiths E, Stein E, Brunner A, McMahon C, Shallis R, Zeidner J, Savona M, Frumm S, Barua S, Chandhok N, Logothetis C, Bidikian A, Getz T, Roboz G, Wang E, Harris A, Amaya M, Hawkins H, Ball S, Grenet J, Xie Z, Madanat Y, Abaza Y, Badar T, Haferlach T, Maciejewski J, Sallman D, Enjeti A, Al-Rabi K, Halahleh K, Hiwase D, Diez-Campelo M, Valcarcel D, Haferlach C, Pleyer L, Kotsianidis I, Pappa V, Santini V, Consagra A, Al-Kali A, Ogawa S, Nannya Y, Della Porta M, Komrokji R, Zeidan A, Stahl M. Impact of Response to Hypomethylating Agent-Based Therapy on Survival Outcomes in the Context of Baseline Clinical-Molecular Risk and Transplant Status in Patients with Myelodysplastic Syndromes/Neoplasms (MDS): An Analysis from the International Consortium for MDS (icMDS) Validate Database. Blood 2024, 144: 664-664. DOI: 10.1182/blood-2024-208034.Peer-Reviewed Original ResearchComposite complete responseAllo-HCTOverall survivalComplete responseIPSS-MHMA therapyMedian OSResponse criteriaAllogeneic stem cell transplantationPartial hematologic recoveryClinical response criteriaStem cell transplantationHypomethylating agent-based therapyAgent-based therapyClinical practiceCox regression analysisResponse to treatmentAvailability of donorsDecitabine monotherapyImpact OSOS benefitHematologic recoveryAzacitidine monotherapyCell transplantationCombination therapyDual Bclxl and BCL2 Inhibition with Navitoclax (NAV), Venetoclax (VEN), and Decitabine (DEC) for Advanced Myeloid Neoplasms (MN): Safety and Biological Activity in a Phase 1 Study
Chen E, Liu Y, Bell H, Galinsky I, Luskin M, Winer E, Stahl M, Vedula R, Volpe V, DeAngelo D, Quillen K, Ryan J, Minihane E, Hersch M, Leonard R, Neuberg D, Stone R, Letai A, Lane A, Garcia J. Dual Bclxl and BCL2 Inhibition with Navitoclax (NAV), Venetoclax (VEN), and Decitabine (DEC) for Advanced Myeloid Neoplasms (MN): Safety and Biological Activity in a Phase 1 Study. Blood 2024, 144: 4580-4580. DOI: 10.1182/blood-2024-198284.Peer-Reviewed Original ResearchAcute myeloid leukemiaAdvanced myeloid neoplasmsDose-limiting toxicityPhase 1 studyIncreased apoptotic primingMyeloid neoplasmsNavitoclax doseOverall survivalDNA methyltransferase inhibitorHematologic recoveryApoptotic primingTherapy-related acute myeloid leukemiaDose levelsHematologic dose-limiting toxicityHigh-risk myeloid neoplasmsRecommended phase 2 doseSecondary acute myeloid leukemiaNewly-diagnosed acute myeloid leukemiaResponse rateIncomplete hematologic recoveryPartial hematologic recoveryPhase 2 doseBCL2 inhibitor venetoclaxImmature platelet fractionMyelodysplastic syndrome/myeloproliferative neoplasm
2023
Validation of the Composite Complete Response (cCR) Definitions in the International Working Group (IWG) 2023 Criteria in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Treated with Hypomethylating Agents (HMA) - a Large, Multicenter, Retrospective Analysis from the Validate Database
Bewersdorf J, Kewan T, Blaha O, Stahl M, Al Ali N, DeZern A, Sekeres M, Uy G, Carraway H, Desai P, Griffiths E, Stein E, Brunner A, McMahon C, Zeidner J, Savona M, Stempel J, Chandhok N, Logothetis C, Roboz G, Rolles B, Wang E, Harris A, Amaya M, Hawkins H, Grenet J, Shallis R, Xie Z, Maciejewski J, Sallman D, Della Porta M, Komrokji R, Zeidan A. Validation of the Composite Complete Response (cCR) Definitions in the International Working Group (IWG) 2023 Criteria in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Treated with Hypomethylating Agents (HMA) - a Large, Multicenter, Retrospective Analysis from the Validate Database. Blood 2023, 142: 324. DOI: 10.1182/blood-2023-180299.Peer-Reviewed Original ResearchImproved OSHypomethylating agentHMA initiationMedian OSResponse assessmentTP53 mutationsResponse definitionsPartial hematologic recoveryPredictors of OSMultivariable Cox modelBone marrow blastsKaplan-Meier analysisLog-rank testOverall response rateEfficacy of therapyMultivariable regression modelsReal-world analysisAllo-HCTBM assessmentBM evaluationHemoglobin thresholdHematologic recoveryMarrow blastsMedian durationMedian ageEvolution of Therapeutic Benefit Measurement Criteria in Myelodysplastic Syndromes/Neoplasms
Stempel J, Xie Z, Bewersdorf J, Stahl M, Zeidan A. Evolution of Therapeutic Benefit Measurement Criteria in Myelodysplastic Syndromes/Neoplasms. The Cancer Journal 2023, 29: 203-211. PMID: 37195777, DOI: 10.1097/ppo.0000000000000666.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsInternational Working Group response criteriaResponse criteriaPhase III clinical trialsIWG 2006 criteriaRisk of progressionPatient-focused outcomesClonal myeloid neoplasmsAcute myeloid leukemiaTherapeutic response assessmentPatient-centered responsesNovel drug developmentHematologic recoveryProgressive cytopeniasClinical trialsIWG criteriaLong-term benefitsMyeloid leukemiaIneffective hematopoiesisMyeloid neoplasmsResponse assessmentDisease severityConsensus proposal for revised International Working Group response criteria for higher risk myelodysplastic syndromes
Zeidan A, Platzbecker U, Bewersdorf J, Stahl M, Adès L, Borate U, Bowen D, Buckstein R, Brunner A, Carraway H, Daver N, Díez-Campelo M, de Witte T, DeZern A, Efficace F, Garcia-Manero G, Garcia J, Germing U, Giagounidis A, Griffiths E, Hasserjian R, Hellström-Lindberg E, Iastrebner M, Komrokji R, Kulasekararaj A, Malcovati L, Miyazaki Y, Odenike O, Santini V, Sanz G, Scheinberg P, Stauder R, van de Loosdrecht A, Wei A, Sekeres M, Fenaux P. Consensus proposal for revised International Working Group response criteria for higher risk myelodysplastic syndromes. Blood 2023, 141: 2047-2061. PMID: 36724453, DOI: 10.1182/blood.2022018604.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsHigh-risk MDSComplete remissionResponse criteriaInternational Working GroupClinical trialsHigh-risk myelodysplastic syndromeEnd pointMarrow complete remissionPartial hematologic recoveryClinical end pointsPatient-centered outcomesNovel investigational drugsVariable clinical presentationEvent end pointsHemoglobin thresholdHematologic recoveryCount recoveryClinical presentationClinical benefitMyelodysplastic syndromeIWG criteriaMyelodysplastic neoplasmsConsensus recommendationsInvestigational drugsNew agents
2022
Evaluating complete remission with partial hematologic recovery (CRh) as a response criterion in myelodysplastic syndromes (MDS)
Brunner A, Gavralidis A, Ali N, Hunter A, Komrokji R, Zeidan A, Sallman D. Evaluating complete remission with partial hematologic recovery (CRh) as a response criterion in myelodysplastic syndromes (MDS). Blood Cancer Journal 2022, 12: 153. PMID: 36379923, PMCID: PMC9666661, DOI: 10.1038/s41408-022-00748-9.Peer-Reviewed Original ResearchConceptsPartial hematologic recoveryMyelodysplastic syndromeHematologic recoveryResponse criteriaCR/CRhIWG 2006 criteriaDuration of therapyBest overall responseTime of therapyCR responseCRH responseDNMTi therapyOS associationComplete remissionMedian OSOverall survivalAdult patientsAllogeneic transplantsMedian ageMDS patientsMultivariable analysisClinical trialsSimilar survivalPatientsTherapy
2021
The complete story of less than complete responses: The evolution and application of acute myeloid leukemia clinical responses
Shallis RM, Pollyea DA, Zeidan AM. The complete story of less than complete responses: The evolution and application of acute myeloid leukemia clinical responses. Blood Reviews 2021, 48: 100806. PMID: 33531169, DOI: 10.1016/j.blre.2021.100806.Peer-Reviewed Original ResearchConceptsComplete remissionAcute myeloid leukemiaClinical benefitRate of CRMeasurable residual disease assessmentIncomplete platelet recoveryNon-intensive therapyPartial hematologic recoveryResidual disease assessmentFuture clinical trialsPost-therapy outcomesClinical responseHematologic recoveryOlder patientsComplete responseIntensive therapyStringent response criteriaPlatelet recoveryTherapeutic responseClinical trialsMyeloid leukemiaClinical valueNew therapiesMRD techniquesResponse criteria
2019
Mutant IDH1 inhibitor ivosidenib (IVO; AG-120) in combination with azacitidine (AZA) for newly diagnosed acute myeloid leukemia (ND AML).
Dinardo C, Stein A, Stein E, Fathi A, Frankfurt O, Schuh A, Martinelli G, Patel P, Raffoux E, Tan P, Zeidan A, de Botton S, Kantarjian H, Stone R, Lam D, Gong J, Zhang V, Winkler T, Wu B, Vyas P. Mutant IDH1 inhibitor ivosidenib (IVO; AG-120) in combination with azacitidine (AZA) for newly diagnosed acute myeloid leukemia (ND AML). Journal Of Clinical Oncology 2019, 37: 7011-7011. DOI: 10.1200/jco.2019.37.15_suppl.7011.Peer-Reviewed Original ResearchAdverse eventsECG QTFebrile neutropeniaDouble-blind placebo-controlled studyGrade 3/4 adverse eventsBone marrow mononuclear cellsCR/CRhGrade adverse eventsIDH differentiation syndromeIDH1 inhibitor ivosidenibMedian response durationNon-intensive therapyPartial hematologic recoveryPhase 1b studyPlacebo-controlled studyAcute myeloid leukemiaMarrow mononuclear cellsAZA monotherapyD1-7Differentiation syndromeData cutoffHematologic recoveryMedian durationMedian timeSafety profile
1998
Peripheral blood progenitor cell cycle kinetics following priming with pIXY321 in patients treated with the "ICE" regimen.
Murren JR, Gollerkeri A, Anderson S, Lutzker S, Del Prete S, Zelterman D, Garrison L, Smith B. Peripheral blood progenitor cell cycle kinetics following priming with pIXY321 in patients treated with the "ICE" regimen. The Yale Journal Of Biology And Medicine 1998, 71: 355-65. PMID: 10527363, PMCID: PMC2578930.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungCarcinoma, Small CellCell CycleEtoposideFemaleGranulocyte-Macrophage Colony-Stimulating FactorHematopoietic Stem CellsHumansIfosfamideInterleukin-3Lung NeoplasmsMaleMiddle AgedNeutropeniaRecombinant Fusion ProteinsSurvival RateTreatment OutcomeConceptsCell lung cancerPeripheral bloodLung cancerGrowth factorProgenitor cellsDay 1Non-small cell lung cancerSmall cell lung cancerCycle-specific chemotherapyCell cycle distributionHematopoietic growth factorsProgenitor cell cyclingHematologic recoveryPartial responseHematopoietic progenitor cellsCell cycle kineticsPreclinical dataCertain growth factorsSpecific chemotherapySubcutaneous injectionTransient fallCycling progenitor cellsReduced riskPatientsMarrow compartment
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