2023
Characteristics and Outcomes of Younger Adult Patients (Pts) with Myelodysplastic Syndromes (MDS): A Multicenter Retrospective Study
Abaza Y, Xie Z, Burkart M, Badar T, Desai P, Shallis R, Patel A, Cohen-Nowak A, Oh T, Walker C, Easwar N, Kewan T, Cannova J, Bell-Burdett K, Al Ali N, Sallman D, Roboz G, Carraway H, Zeidan A, Patnaik M, Altman J, Komrokji R. Characteristics and Outcomes of Younger Adult Patients (Pts) with Myelodysplastic Syndromes (MDS): A Multicenter Retrospective Study. Blood 2023, 142: 3232. DOI: 10.1182/blood-2023-188328.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeMedian overall survivalMulticenter retrospective studyRisk myelodysplastic syndromesOverall survivalYA groupMyelodysplastic syndromeYounger ptsComplete remissionAllo-SCTBaseline characteristicsFrontline therapyHematologic improvementMedian ageRetrospective studyCommon subtypeBlasts-2Exact testUpfront allogeneic stem cell transplantationIntermediate-risk myelodysplastic syndromesTherapy-related myelodysplastic syndromeAllogeneic stem cell transplantationDe novo myelodysplastic syndromeExcess blasts-2Marrow complete remissionSabatolimab in Combination with Hypomethylating Agents (HMAs) Was Safe in Patients (Pts) with Intermediate-, High-, or Very-High-Risk Myelodysplastic Syndrome (MDS)
Garcia-Manero G, Lyons R, Nandal S, Ashraf M, Thellaboina R, Ruckel-Kumar J, Menssen H, Zeidan A. Sabatolimab in Combination with Hypomethylating Agents (HMAs) Was Safe in Patients (Pts) with Intermediate-, High-, or Very-High-Risk Myelodysplastic Syndrome (MDS). Blood 2023, 142: 4606. DOI: 10.1182/blood-2023-186490.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeAdverse eventsHematologic improvementPartial remissionMyelodysplastic syndromeHypomethylating agentMarrow CRInterim analysisStable diseaseData cutoffLast doseInternational Prognostic Scoring System criteriaResponse rateCount decreaseCycle 1 day 1Second-line treatment optionExtension phaseHematologic adverse eventsNeutrophil count decreaseOral hypomethylating agentPhase Ib studySerious adverse eventsFatal adverse eventsMonths of treatmentSingle-arm study
2021
Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study
Garcia-Manero G, McCloskey J, Griffiths E, Yee K, Zeidan A, Al-Kali A, Deeg H, Patel P, Sabloff M, Keating M, Dao K, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern A, O'Connell C, Roboz G, Busque L, Wells R, Amin H, Randhawa J, Leber B, Hao Y, Keer H, Azab M, Savona M. Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study. Blood 2021, 138: 66. PMCID: PMC8701611, DOI: 10.1182/blood-2021-144648.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesClinical Trials CommitteeMedian leukemia-free survivalMedian overall survivalRisk myelodysplastic syndromesBristol-Myers SquibbMyelodysplastic syndromeTransfusion independenceTrials CommitteeOral DECDNA methyltransferase inhibitorOverall survivalComplete responseAstex PharmaceuticalsSpeakers bureauCC-486Hematologic improvementDaiichi SankyoTreatment-emergent adverse eventsHigh-risk MDS patientsAllogeneic stem cell transplantSARS-CoV-2 infectionAdvisory CommitteeRandomized cross-over studyPandemic SARS-CoV-2 infectionOutcomes for Patients with Late-Stage Mutant-IDH2 (m IDH2) Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treated with Enasidenib Vs Other Lower-Intensity Therapies in the Randomized, Phase 3 IDHentify Trial
DiNardo C, Montesinos P, Schuh A, Papayannidis C, Vyas P, Wei A, Zeidan A, Bluemmert I, Yu X, Hasan M, Martin-Regueira P, de Botton S. Outcomes for Patients with Late-Stage Mutant-IDH2 (m IDH2) Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treated with Enasidenib Vs Other Lower-Intensity Therapies in the Randomized, Phase 3 IDHentify Trial. Blood 2021, 138: 1243. DOI: 10.1182/blood-2021-147593.Peer-Reviewed Original ResearchClinical Trials CommitteeBest supportive careEvent-free survivalBristol-Myers SquibbIntermediate-dose cytarabineMedian overall survivalR AMLOverall survivalHematologic improvementTransfusion independenceTrials CommitteeCurrent equity holderSpeakers bureauDaiichi SankyoRefractory acute myeloid leukemiaAdvisory CommitteeAdverse-risk AMLConventional care regimensLow-dose cytarabineMedian age overallPrimary refractory AMLStudy drug doseOpen-label trialLow-intensity therapyOverall response rateEvaluating Complete Remission with Incomplete Hematologic Recovery (CRh) As a Response Criterion in Myelodysplastic Syndromes (MDS)
Brunner A, Gavralidis A, Al Ali N, Komrokji R, Zeidan A, Sallman D. Evaluating Complete Remission with Incomplete Hematologic Recovery (CRh) As a Response Criterion in Myelodysplastic Syndromes (MDS). Blood 2021, 138: 1522. DOI: 10.1182/blood-2021-151815.Peer-Reviewed Original ResearchClinical Trials CommitteeStable diseaseComplete remissionHMA therapyBone marrow blastsHematologic improvementProgressive diseaseMyelodysplastic syndromePartial remissionTrials CommitteeResponse criteriaMarrow blastsOverall survivalSpeakers bureauHigh-risk myelodysplastic syndromeAdvisory CommitteeIncomplete hematologic recoveryIWG 2006 criteriaMethod of KaplanRisk myelodysplastic syndromesOngoing prospective studyMoffitt Cancer CenterBest overall responsePrediction of OSMassachusetts General Hospital
2020
Blast MRD AML-1 Trial: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia (AML) 1- an Investigator-Initiated, CTEP-Sponsored, Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy (IC) As Frontline Therapy in Patients with Acute Myeloid Leukemia (AML)
Zeidan A, Boddu P, Wood B, Zelterman D, Little R, Ivy S, Caldwell A, Sanchez-Espiridion B, Alatrash G, Sharon E, Radich J. Blast MRD AML-1 Trial: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia (AML) 1- an Investigator-Initiated, CTEP-Sponsored, Randomized Phase 2 Study of the Anti-PD-1 Antibody Pembrolizumab in Combination with Conventional Intensive Chemotherapy (IC) As Frontline Therapy in Patients with Acute Myeloid Leukemia (AML). Blood 2020, 136: 15. DOI: 10.1182/blood-2020-139668.Peer-Reviewed Original ResearchMRD-negative complete responsesAcute myeloid leukemiaMinimal residual diseaseEvent-free survivalImmune checkpoint inhibitionPhase 2 studyIntensive chemotherapyDuration of responseComplete responseOverall survivalPD-1AML patientsDay 1Free survivalHematologic improvementInitial treatmentStudy armsResidual diseaseDay IVLeukemia-specific T-cell responsesSingle-arm phase 2 studyPD-1/PD-L1 pathwayTherapy-related acute myeloid leukemiaCancer Therapy Evaluation ProgramImmune cell subsets analysisBlast MRD AML-2: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MDR) in Acute Myeloid Leukemia (AML) 2- a Randomized Phase 2 Study of the Venetoclax, Azacitidine, and Pembrolizumab Versus Venetoclax and Azacitidine As First Line Therapy in Older Patients with AML Who Are Ineligible or Who Refuse Intensive Chemotherapy
Zeidan A, Boddu P, Wood B, Zelterman D, Little R, Ivy S, Caldwell A, Sanchez-Espiridion B, Alatrash G, Sharon E, Radich J. Blast MRD AML-2: Blockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease (MDR) in Acute Myeloid Leukemia (AML) 2- a Randomized Phase 2 Study of the Venetoclax, Azacitidine, and Pembrolizumab Versus Venetoclax and Azacitidine As First Line Therapy in Older Patients with AML Who Are Ineligible or Who Refuse Intensive Chemotherapy. Blood 2020, 136: 11-12. DOI: 10.1182/blood-2020-139752.Peer-Reviewed Original ResearchEvent-free survivalDuration of responseMRD-negative CRIntensive chemotherapyOverall survivalDay 1Complete remissionFree survivalHematologic improvementOlder patientsSecondary AMLPD-1Study armsAML patientsInitial treatmentHematologic disordersLeukemia-specific T-cell responsesCancer Therapy Evaluation ProgramCR/complete remissionImmune cell subsets analysisRandomized phase 2 studyRandomized phase 2 trialRandomized phase II studyAllogeneic stem cell transplantBetter long-term clinical outcomes
2019
Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine
Garcia-Manero G, McCloskey J, Griffiths E, Yee K, Zeidan A, Al-Kali A, Dao K, Deeg H, Patel P, Sabloff M, Keating M, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Shastri A, DeZern A, O'Connell C, Roboz G, Oganesian A, Hao Y, Keer H, Azab M, Savona M. Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine. Blood 2019, 134: 846. DOI: 10.1182/blood-2019-122980.Peer-Reviewed Original ResearchPhase 3 studyFixed-dose combinationClinical trialsHematologic improvementAdverse eventsAstex PharmaceuticalsSpeakers bureauIncyte CorporationSafety findingsComplete responseRandomized crossOtsuka PharmaceuticalClinical activityHypomethylating agentOral fixed-dose combinationCelgene CorporationRandomized phase 3 studyBoehringer IngelheimAdvisory CommitteeSeattle GeneticsDaiichi SankyoClinic visit frequencyComparable clinical activityDifferent myeloid malignanciesPlatelet transfusion dependence
2018
Hypomethylating agents in relapsed and refractory AML: outcomes and their predictors in a large international patient cohort
Stahl M, DeVeaux M, Montesinos P, Itzykson R, Ritchie EK, Sekeres MA, Barnard JD, Podoltsev NA, Brunner AM, Komrokji RS, Bhatt VR, Al-Kali A, Cluzeau T, Santini V, Fathi AT, Roboz GJ, Fenaux P, Litzow MR, Perreault S, Kim TK, Prebet T, Vey N, Verma V, Germing U, Bergua JM, Serrano J, Gore SD, Zeidan AM. Hypomethylating agents in relapsed and refractory AML: outcomes and their predictors in a large international patient cohort. Blood Advances 2018, 2: 923-932. PMID: 29685952, PMCID: PMC5916007, DOI: 10.1182/bloodadvances.2018016121.Peer-Reviewed Original ResearchConceptsOverall survivalRR-AMLMedian OSOlder acute myeloid leukemia patientsAcute myeloid leukemia patientsCR/CRiIncomplete count recoveryMedian overall survivalDecreased overall survivalBone marrow blastsReasonable therapeutic optionMyeloid leukemia patientsPredictors of responseImproved response ratesLarge international patient cohortInternational patient cohortGood responseComplete remissionHematologic improvementRefractory AMLMarrow blastsMedian ageCount recoveryFrontline treatmentTherapeutic options
2016
The Use of Hypomethylating Agents (HMAs) in Patients with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML): Clinical Outcomes and Their Predictors in a Large International Patient Cohort
Stahl M, Podoltsev N, DeVeaux M, Perreault S, Itzykson R, Ritchie E, Sekeres M, Fathi A, Komrokji R, Bhatt V, Al-Kali A, Cluzeau T, Santini V, Brunner A, Roboz G, Fenaux P, Litzow M, Vey N, Verma V, Germing U, Fernández P, Zelterman D, Kim T, Prebet T, Gore S, Zeidan A. The Use of Hypomethylating Agents (HMAs) in Patients with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML): Clinical Outcomes and Their Predictors in a Large International Patient Cohort. Blood 2016, 128: 1063. DOI: 10.1182/blood.v128.22.1063.1063.Peer-Reviewed Original ResearchMultivariable logistic regression modelRR-AMLMinority of patientsOverall survivalPrior linesHypomethylating agentHMA therapyMedian numberLogistic regression modelsChromosome 7 abnormalitiesStable diseaseBlast percentageHematologic improvementProgressive diseaseHazard ratioClinical outcomesSpeakers bureauMultivariable Cox proportional hazards modelsPeripheral blood blast percentageRefractory acute myeloid leukemiaAllogeneic stem cell transplantationInternational Working Group criteriaWhite blood cell countCox proportional hazards modelBM blast percentage
2015
Lenalidomide Treatment for Lower Risk Nondeletion 5q Myelodysplastic Syndromes Patients Yields Higher Response Rates When Used Before Azacitidine
Zeidan AM, Al Ali N, Padron E, Lancet J, List A, Komrokji RS. Lenalidomide Treatment for Lower Risk Nondeletion 5q Myelodysplastic Syndromes Patients Yields Higher Response Rates When Used Before Azacitidine. Clinical Lymphoma Myeloma & Leukemia 2015, 15: 705-710. PMID: 26440749, DOI: 10.1016/j.clml.2015.08.083.Peer-Reviewed Original ResearchConceptsLower-risk myelodysplastic syndromesFirst-line therapyErythropoiesis-stimulating agentsFailure of treatmentTreatment failureInternational Working Group 2006 criteriaResponse rateSecond-line therapyMyelodysplastic syndrome patientsHigh response rateChromosome 5q deletionAzacitidine useHematologic improvementLenalidomide treatmentOverall survivalAnemic patientsMyelodysplastic syndromeSyndrome patientsLarge cohortLenalidomideAzacitidinePatientsLeukemic progressionClinical databaseTherapy
2014
The Prognostic Utility of the Current Risk Models in Predicting Outcomes of Patients (pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) Treated with Hypomethylating Agents (HMA)
Zeidan A, Sekeres M, Garcia-Manero G, Barnard J, Al Ali N, Zimmerman C, Roboz G, Steensma D, DeZern A, Jabbour E, Kantarjian H, Zell K, Wang Q, Gore S, Nazha A, Maciejewski J, List A, Komrokji R. The Prognostic Utility of the Current Risk Models in Predicting Outcomes of Patients (pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) Treated with Hypomethylating Agents (HMA). Blood 2014, 124: 1935. DOI: 10.1182/blood.v124.21.1935.1935.Peer-Reviewed Original ResearchMD Anderson Prognostic Scoring SystemHigh-risk myelodysplastic syndromeInternational Prognostic Scoring SystemMedian overall survivalHematopoietic cell transplantationPrognostic scoring systemOverall response rateOverall survivalHMA therapyHypomethylating agentComplete responseScoring systemStable diseaseHematologic improvementPartial responseProgressive diseaseConfidence intervalsInternational Working Group 2006 criteriaMDS Clinical Research ConsortiumPrognostic modelRevised International Prognostic Scoring SystemRisk categoriesBoehringer Ingelheim CorpCycles of therapyMarrow complete response
2013
Management of High-Risk Myelodysplastic Syndrome
Zeidan A, Gore S. Management of High-Risk Myelodysplastic Syndrome. Hematologic Malignancies 2013, 189-210. DOI: 10.1007/978-3-642-36229-3_12.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeHR-MDSDNMTi therapyDNA methyltransferase inhibitorEmergence of resistanceTherapeutic optionsMyelodysplastic syndromeNovel agentsAllogeneic hematopoietic stem cell transplantationCare first-line therapyHematopoietic stem cell transplantationDuration of therapyFirst-line therapyComplex pathogenetic mechanismsStem cell transplantationLimited therapeutic optionsGood responseMechanism of actionAzacitidine therapyStable diseaseHematologic improvementIntensive chemotherapyMaintenance therapyUntreated patientsMedian survival