2021
Minimal Toxicity Seen When Pembrolizumab Is Added to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease: Early Results from an Ongoing Phase II Trial (ECOG-ACRIN EA9171)
Zeidan A, Roopcharan K, Radich J, Bewersdorf J, Bhatt V, Sharon E, Little R, Gore S, Caldwell A, Luger S, Litzow M. Minimal Toxicity Seen When Pembrolizumab Is Added to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease: Early Results from an Ongoing Phase II Trial (ECOG-ACRIN EA9171). Blood 2021, 138: 3613. DOI: 10.1182/blood-2021-145015.Peer-Reviewed Original ResearchUndetectable minimal residual diseaseClinical Trials CommitteeTherapy-free remissionCombination of TKIG3 adverse eventsImmune-related AEAdverse eventsTrials CommitteeMinimal residual diseaseSafety cohortTKI discontinuationTKI therapyPD-L1Residual diseasePilot phase II clinical trialPD-1/PD-L1Detectable minimal residual diseaseImmune-related adverse eventsNon-hematologic adverse eventsAnti-PD-1 antibodyOngoing phase II trialBCR-ABLPhase II clinical trialAdvisory CommitteeDaiichi SankyoOral 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 infectionAnalysis of Duration of Response, Exposure-Adjusted Safety and Progression to Acute Myeloid Leukemia (AML) for Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) Receiving Luspatercept in the MEDALIST Study
Platzbecker U, Santini V, Komrokji R, Zeidan A, Garcia-Manero G, Buckstein R, Rose S, Fabre S, Miteva D, Zhang J, Yucel A, Hughes C, Fenaux P. Analysis of Duration of Response, Exposure-Adjusted Safety and Progression to Acute Myeloid Leukemia (AML) for Patients with Lower-Risk Myelodysplastic Syndromes (LR-MDS) Receiving Luspatercept in the MEDALIST Study. Blood 2021, 138: 1524. DOI: 10.1182/blood-2021-145723.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesTreatment-emergent adverse eventsClinical Trials CommitteeAcute myeloid leukemiaErythropoiesis-stimulating agentsExposure-adjusted incidence ratesRBC-TITrials CommitteeEntire treatment periodDuration of treatmentRing sideroblastsAML progressionCurrent equity holderMedian durationTreatment optionsIncidence rateTreatment periodWk 1Only treatment-emergent adverse eventClass erythroid maturation agentMDS/myeloproliferative neoplasmAdvisory CommitteeRegular RBC transfusionsTolerable safety profileSpeakers bureauOutcomes 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 rateCharacteristics and Clinical Outcome of Patients with Clonal Cytopenias of Undetermined Significance: A Large Retrospective Multi-Center International Study
Xie Z, Hyun M, Komrokji R, Zeidan A, Madanat Y, Zeidner J, Coombs C, Griffiths E, Lai C, Kishtagari A, Foran J, Badar T, Yi C, Desai P, Ades L, Osman A, Taylor J, Deeg H, Brunner A, Carraway H, Al Ali N, Bewersdorf J, Prebet T, Singh A, Tsai C, Chandhok N, Soong D, Patnaik M, Savona M, Al-Kali A. Characteristics and Clinical Outcome of Patients with Clonal Cytopenias of Undetermined Significance: A Large Retrospective Multi-Center International Study. Blood 2021, 138: 2158. DOI: 10.1182/blood-2021-146254.Peer-Reviewed Original ResearchClinical Trials CommitteeProgression-free survivalIndependent review committeeOverall survivalTrials CommitteeDisease progressionBristol-Myers SquibbMyeloid neoplasmsResponse rateFunctional pathway analysisSpeakers bureauUndetermined significanceMultivariable modelClonal cytopeniaReview CommitteeMedian progression-free survivalBoehringer IngelheimAdvisory CommitteeMulti-centre international studyCG abnormalitiesCox proportional hazards modelGene panelDaiichi SankyoBaseline clinical dataKaplan-Meier methodPredictive Biomarkers of Response to the Polo-like Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Decitabine in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
Zeidan A, Ridinger M, Croucher P, Samuëlsz E, Erlander M, Ruffner K, Wang E. Predictive Biomarkers of Response to the Polo-like Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Decitabine in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML). Blood 2021, 138: 3431. DOI: 10.1182/blood-2021-145129.Peer-Reviewed Original ResearchClinical Trials CommitteeCurrent equity holderR AML patientsClinical responseTrials CommitteeGene expression signaturesSpeakers bureauAML patientsSingle agentMulticenter phase 2 studyPhase 1b/2 clinical trialRefractory acute myeloid leukemiaData Safety Monitoring CommitteeAdvisory CommitteeDaiichi SankyoSF mutationsCR/CRiPhase 2 studySafety Monitoring CommitteeChronic myelomonocytic leukemiaCycles of treatmentExpression signaturesComplete hematologic recoveryAcute myeloid leukemiaBone marrow samplesVenetoclax Plus Azacitidine (VEN-AZA) Vs. Intensive Chemotherapy (IC) As Induction for Patients with Acute Myeloid Leukemia (AML): Retrospective Analysis of an Electronic Medical Records (EMR) Database in the United States
Zeidan A, Pollyea D, Borate U, Vasconcelos A, Potluri R, Rotter D, Kiendrebeogo Z, Gaugler L, Bonifacio G, Chen C. Venetoclax Plus Azacitidine (VEN-AZA) Vs. Intensive Chemotherapy (IC) As Induction for Patients with Acute Myeloid Leukemia (AML): Retrospective Analysis of an Electronic Medical Records (EMR) Database in the United States. Blood 2021, 138: 277. DOI: 10.1182/blood-2021-147926.Peer-Reviewed Original ResearchClinical Trials CommitteeRelapse-free survivalAcute myeloid leukemiaMedian relapse-free survivalCurrent equity holderElectronic medical record databaseBristol-Myers SquibbSubgroups of ptsIntensive chemotherapyIC cohortStart of therapyOverall survivalTrials CommitteeMedical record databaseRemission rateCR rateAge-based subgroupsYears subgroupRecord databaseIncomplete hematologic recovery (CRi) ratesReal-world clinical practicePhase 3 trial dataAdvisory CommitteeDaiichi SankyoGood remission 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
Gilteritinib Remains Clinically Active in Relapsed/Refractory FLT3 Mutated AML Previously Treated with FLT3 inhibitors
Numan Y, Rahman Z, Grenet J, Boisclair S, Bewersdorf J, Barth D, Zeidan A, Yilmaz M, Dinner S, Deutsch Y, Frankfurt O, Litzow M, Al-Kali A, Foran J, Sproat L, Jovanovic B, Daver N, Perl A, Altman J. Gilteritinib Remains Clinically Active in Relapsed/Refractory FLT3 Mutated AML Previously Treated with FLT3 inhibitors. Blood 2020, 136: 5-7. DOI: 10.1182/blood-2020-137251.Peer-Reviewed Original ResearchStem cell transplantMedian survivalFLT3 mutationsBristol-Myers SquibbDaiichi SankyoBoehringer IngelheimCRC ratesLymphoma SocietyCombination therapyPolymerase chain reactionFLT3-ITDSingle agentDrug resistanceAdvisory CommitteeBone marrow flow cytometryComposite complete remissionFLT3-D835 mutationsHigher CRCS ratesNon-transplanted patientsPoor median survivalKaplan-Meier curvesMulti-institutional analysisLog-rank testBayer HealthCare PharmaceuticalsMAPK pathwaySafety and Efficacy of Maintenance Treatment Following Allogeneic Hematopoietic Cell Transplant in Acute Myeloid Leukemia and Myelodysplastic Syndrome - a Systematic Review and Meta-Analysis
Bewersdorf J, Tallman M, Cho C, Zeidan A, Stahl M. Safety and Efficacy of Maintenance Treatment Following Allogeneic Hematopoietic Cell Transplant in Acute Myeloid Leukemia and Myelodysplastic Syndrome - a Systematic Review and Meta-Analysis. Blood 2020, 136: 34-35. DOI: 10.1182/blood-2020-136671.Peer-Reviewed Original ResearchAcute myeloid leukemiaRelapse-free survivalAllogeneic hematopoietic cell transplantHematopoietic cell transplantFLT3 inhibitorsMyelodysplastic syndromeAllo-HCTOverall survivalRFS ratesChronic GVHDMaintenance therapyCell transplantPatient selectionClinical trialsMyeloid leukemiaADC therapeuticsSystematic reviewMinimal residual disease testingAdvisory CommitteeDaiichi SankyoHigh-risk geneticsRate of GVHDPre-emptive treatmentCareful patient selectionPrognosis of patientsClinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Savona M, McCloskey J, Griffiths E, Yee K, Al-Kali A, Zeidan 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, Garcia-Manero G. Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML). Blood 2020, 136: 37-38. PMCID: PMC8330281, DOI: 10.1182/blood-2020-133855.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaRed blood cellsMyelodysplastic syndromeComplete responseHematological improvementAdverse eventsAstex PharmaceuticalsHypomethylating agentConsecutive weeksSpeakers bureauMedian durationClinical efficacyDaiichi SankyoDNA methyltransferase inhibitorCommon treatment-emergent adverse eventsAllogeneic hematopoietic cell transplantTreatment-emergent adverse eventsTreatment of MDSBoehringer IngelheimAdvisory CommitteeRandomized cross-over studySeattle GeneticsDose combination drugsOral hypomethylating agentOverall objective responseThe STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML)
Zeidan A, Esteve J, Giagounidis A, Kim H, Miyazaki Y, Platzbecker U, Schuh A, Sekeres M, Westermann J, Xiao Z, Malek K, Scott J, Niolat J, Peyrard S, Ma F, Kiertsman F, Stegert M, Hertle S, Fenaux P, Santini V. The STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML). Blood 2020, 136: 45-46. DOI: 10.1182/blood-2020-134718.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeHematopoietic stem cell transplantationAcute myeloid leukemiaEvent-free survivalLeukemic stem cellsIntensive chemotherapyOverall survivalPrimary endpointSecondary endpointsCurrent equity holderEligible ptsTim-3Transfusion independenceCombination therapyEastern Cooperative Oncology Group performance statusCR/CRi rateEncouraging overall response rateAdvisory CommitteeDaiichi SankyoDuration of CRTransfusion-free intervalLeukemia-free survivalComplete remission rateHigh-risk MDSProgression-free survivalMolecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine
Daigle S, Choe S, DiNardo C, Stein A, Stein E, Fathi A, Frankfurt O, Schuh A, Döhner H, Martinelli G, Patel P, Raffoux E, Tan P, Zeidan A, De Botton S, Stone R, Frattini M, Franovic A, Xu E, Winkler T, Wu B, Vyas P. Molecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine. Blood 2020, 136: 49-51. DOI: 10.1182/blood-2020-136922.Peer-Reviewed Original ResearchPeripheral blood mononuclear cellsAcute myeloid leukemiaBone marrow mononuclear cellsCurrent equity holderIntensive induction chemotherapyAgios PharmaceuticalsSafety monitoring boardIsocitrate dehydrogenase 1Daiichi SankyoSeattle GeneticsSpeakers bureauBristol-Myers SquibbIDH2 mutationsPTC TherapeuticsClinical responseMononuclear cellsClinical trialsDisease progressionMyeloid leukemiaMonitoring boardRefractory (R/R) AMLMutant IDH1R AMLAdvisory CommitteeForty-sevenEfficacy and Safety of Luspatercept Treatment in Patients with Myelodysplastic Syndrome/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A Retrospective Analysis from the Medalist Study
Komrokji R, Platzbecker U, Fenaux P, Garcia-Manero G, Mufti G, Santini V, Diez-Campelo M, Finelli C, Jurcic J, Greenberg P, Sekeres M, Zeidan A, DeZern A, Savona M, Shetty J, Ito R, Zhang G, Ha X, Sinsimer D, Backstrom J, Verma A. Efficacy and Safety of Luspatercept Treatment in Patients with Myelodysplastic Syndrome/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A Retrospective Analysis from the Medalist Study. Blood 2020, 136: 13-15. DOI: 10.1182/blood-2020-137232.Peer-Reviewed Original ResearchMDS/MPN-RSCurrent equity holderMedian leukocyte countMedian platelet countPlacebo armRing sideroblastsSpeakers bureauRBC-TIPrimary endpointClinical benefitPlatelet countTreatment optionsLeukocyte countRetrospective analysisMyelodysplastic syndrome/myeloproliferative neoplasmClass erythroid maturation agentMean serum ferritin levelWk 1Boehringer IngelheimAdvisory CommitteeDaiichi SankyoClinical benefit responseMean Hb increaseRBC transfusion independenceRegular RBC transfusions
2019
The Impact of the 2011 European Leukemianet (ELN) Guidelines for Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms on Therapeutic Phlebotomy and Hydroxyurea Use in Patients with Polycythemia Vera and Essential Thrombocythemia
Podoltsev N, Wang R, Shallis R, Huntington S, Zeidan A, Gore S, Davidoff A, Ma X. The Impact of the 2011 European Leukemianet (ELN) Guidelines for Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms on Therapeutic Phlebotomy and Hydroxyurea Use in Patients with Polycythemia Vera and Essential Thrombocythemia. Blood 2019, 134: 2125. DOI: 10.1182/blood-2019-127563.Peer-Reviewed Original ResearchTherapeutic phlebotomyPopulation-based cohortPV patientsELN guidelinesET patientsPolycythemia veraEssential thrombocythemiaGuideline publicationCelgene CorporationCytoreductive therapyHU useMonthly proportionBoehringer IngelheimLarge population-based cohortAdvisory CommitteeDaiichi SankyoOlder adultsEuropean LeukemiaNet guidelinesEnd Results-MedicareProportion of patientsHealthcare Common Procedure Coding System codesPopulation-based studyPatterns of careTreatment of patientsPart D claimsPatterns of Care and Clinical Outcomes with 7+3 Induction Chemotherapy for Patients (pts) with Acute Myeloid Leukemia (AML) in the United States (US): A Large Population-Based Study
Zeidan A, Podoltsev N, Wang X, Bewersdorf J, Shallis R, Huntington S, Neparidze N, Giri S, Gore S, Ma X, Davidoff A, Wang R. Patterns of Care and Clinical Outcomes with 7+3 Induction Chemotherapy for Patients (pts) with Acute Myeloid Leukemia (AML) in the United States (US): A Large Population-Based Study. Blood 2019, 134: 116. DOI: 10.1182/blood-2019-126643.Peer-Reviewed Original ResearchBone marrow aspirate/biopsyHigh-volume hospitalsAcute myeloid leukemiaMedium-volume hospitalsAML ptsInduction chemotherapyIntensive care unitAnti-infective medicationsAnti-viral medicationInpatient stayCelgene CorporationAntifungal prophylaxisHospital deathVolume hospitalsHospital volumeMechanical ventilationLarge population-based retrospective cohort studyPopulation-based retrospective cohort studyCytarabine-based induction chemotherapyBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoInduction-related mortalityMedium-volume institutionsClinical Outcomes of Older Patients (pts) with Acute Myeloid Leukemia (AML) Receiving Hypomethylating Agents (HMAs): A Large Population-Based Study in the United States
Zeidan A, Wang R, Wang X, Shallis R, Podoltsev N, Bewersdorf J, Huntington S, Neparidze N, Giri S, Gore S, Davidoff A, Ma X. Clinical Outcomes of Older Patients (pts) with Acute Myeloid Leukemia (AML) Receiving Hypomethylating Agents (HMAs): A Large Population-Based Study in the United States. Blood 2019, 134: 646. DOI: 10.1182/blood-2019-127398.Peer-Reviewed Original ResearchRBC transfusion dependenceAcute myeloid leukemiaMedian overall survivalTransfusion independenceOverall survivalTransfusion dependenceHypomethylating agentCelgene CorporationHMA initiationIntensive chemotherapyOS probabilityMedian timeMultivariable analysisMultivariable Cox proportional hazards modelsBoehringer IngelheimAdvisory CommitteeCox proportional hazards modelDaiichi SankyoChemotherapy-related hospitalizationMo of diagnosisRBC transfusion independenceImproved overall survivalClinical trial evidenceInferior overall survivalWorse overall survivalIncidence and Risk Factors of Second Malignancies Among Medicare Beneficiaries with Newly-Diagnosed Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms Receiving Cytoreductive Therapy with Hydroxyurea
Wang R, Shallis R, Huntington S, Zeidan A, Gore S, Davidoff A, Ma X, Podoltsev N. Incidence and Risk Factors of Second Malignancies Among Medicare Beneficiaries with Newly-Diagnosed Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms Receiving Cytoreductive Therapy with Hydroxyurea. Blood 2019, 134: 330. DOI: 10.1182/blood-2019-127568.Peer-Reviewed Original ResearchMyeloid hematological malignanciesHU usersPopulation-based studyHematological malignanciesCumulative incidenceCelgene CorporationMPN diagnosisCytoreductive therapySolid malignanciesGray's testPolycythemia veraMPN patientsEssential thrombocythemiaContinuous Part D coverageBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoImpact of hydroxyureaRetrospective cohort studyElixhauser comorbidity scorePV/ET myelofibrosisRisk regression modelsSAS version 9.4Part D coverageA Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results
Zeidan A, DeAngelo D, Palmer J, Seet C, Tallman M, Wei X, Li Y, Hock N, Burgess M, Hege K, Stock W. A Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results. Blood 2019, 134: 1320. DOI: 10.1182/blood-2019-125363.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsR AMLHigh-risk myelodysplastic syndromeAnti-drug antibodiesAcute myeloid leukemiaMyelodysplastic syndromeADC therapeuticsJazz PharmaceuticalsDaiichi SankyoCelgene CorporationFebrile neutropeniaDose levelsDevelopment of ADAGrade treatment-emergent adverse eventsSerious treatment-emergent adverse eventsGeneral physical health deteriorationPhase I multicenter studyPrior stem cell transplantRefractory acute myeloid leukemiaRed blood cell transfusionBCR-ABL kinase domainAdvisory CommitteeAnti-CD47 monoclonal antibodyExcess blasts-2Grade 4 sepsisPharmacokinetic 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