2023
Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML
Pratz K, Cherry M, Altman J, Cooper B, Podoltsev N, Cruz J, Lin T, Schiller G, Jurcic J, Asch A, Wu R, Hill J, Gill S, James A, Rich E, Hasabou N, Perl A, Levis M. Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML. Journal Of Clinical Oncology 2023, 41: 4236-4246. PMID: 37379495, DOI: 10.1200/jco.22.02721.Peer-Reviewed Original ResearchConceptsPhase Ib studyMaintenance therapyConsolidation chemotherapyDose escalationFLT3 inhibitorsIb studyHigh-dose cytarabine consolidationMedian overall survival timeSingle-agent maintenance therapyComplete response rateHigher trough levelsOverall survival timeCytarabine consolidationChemotherapy regimenDose expansionAdult patientsIntensive inductionTrough levelsCount recoveryMedian timeRandomized trialsInduction cyclesSurvival timeDay 1Response rate
2022
Follow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial
Perl AE, Larson RA, Podoltsev NA, Strickland S, Wang ES, Atallah E, Schiller GJ, Martinelli G, Neubauer A, Sierra J, Montesinos P, Récher C, Yoon SS, Hosono N, Onozawa M, Chiba S, Kim HJ, Hasabou N, Lu Q, Tiu R, Levis MJ. Follow-up of patients with R/R FLT3-mutation–positive AML treated with gilteritinib in the phase 3 ADMIRAL trial. Blood 2022, 139: 3366-3375. PMID: 35081255, PMCID: PMC9197557, DOI: 10.1182/blood.2021011583.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaSalvage chemotherapyADMIRAL trialSC armOverall survivalFLT3 mutation-positive acute myeloid leukemiaPositive acute myeloid leukemiaComposite complete remissionStable safety profileAdverse event incidenceCommon adverse eventsLiver transaminase levelsMedian overall survivalSuperior overall survivalLong-term treatment effectsGilteritinib armComplete remissionMaintenance therapyAdverse eventsCumulative incidenceMedian survivalTransaminase levelsEvent incidenceMaintenance treatmentSafety profileClinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib
Perl AE, Hosono N, Montesinos P, Podoltsev N, Martinelli G, Panoskaltsis N, Recher C, Smith CC, Levis MJ, Strickland S, Röllig C, Groß-Langenhoff M, Chou WC, Lee JH, Yokoyama H, Hasabou N, Lu Q, Tiu RV, Altman JK. Clinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib. Blood Cancer Journal 2022, 12: 84. PMID: 35637252, PMCID: PMC9151663, DOI: 10.1038/s41408-022-00677-7.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaFLT3-TKIRefractory FLT3TKI exposureSalvage chemotherapyClinical outcomesMyeloid leukemiaR AMLLonger median overall survivalComposite complete remissionHigher CRCS ratesMedian overall survivalTyrosine kinase inhibitor midostaurinKinase inhibitor midostaurinPotential clinical impactADMIRAL trialCRC ratesGilteritinib armPrior sorafenibComplete remissionRemission durationOverall survivalTKI therapyTKI useSurvival outcomes
2021
Molecular testing of isolated myeloid sarcoma allows successful FLT3-targeted therapy
Shallis RM, Pucar D, Perincheri S, Gore SD, Seropian SE, Podoltsev NA, Zeidan AM. Molecular testing of isolated myeloid sarcoma allows successful FLT3-targeted therapy. Annals Of Hematology 2021, 101: 1145-1147. PMID: 34686913, DOI: 10.1007/s00277-021-04702-w.Peer-Reviewed Case Reports and Technical NotesLaboratory evaluation and prognostication among adults and children with CEBPA‐mutant acute myeloid leukemia
Mendoza H, Podoltsev NA, Siddon AJ. Laboratory evaluation and prognostication among adults and children with CEBPA‐mutant acute myeloid leukemia. International Journal Of Laboratory Hematology 2021, 43: 86-95. PMID: 34288448, DOI: 10.1111/ijlh.13517.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsCEBPA mutant acute myeloid leukemiaAcute myeloid leukemiaCEBPA mutationsMyeloid leukemiaLeukemogenic mutationsPositive prognostic impactSingle CEBPA mutationsSimilar survival outcomesNegative prognostic effectFLT3-ITD mutationLaboratory evaluationWild-type CEBPAMultiparameter flow cytometryGermline CEBPA mutationsFavorable prognosisPrognostic impactMutation presencePrognostic effectRisk stratificationSurvival outcomesGATA2 mutationsDistinct subtypesMolecular findingsCEBPA geneFlow cytometryA Phase I dose‐escalation study of DCLL9718S, an antibody‐drug conjugate targeting C‐type lectin‐like molecule‐1 (CLL‐1) in patients with acute myeloid leukemia
Daver N, Salhotra A, Brandwein JM, Podoltsev NA, Pollyea DA, Jurcic JG, Assouline S, Yee K, Li M, Pourmohamad T, Samineni D, Sumiyoshi T, Vaze A, Dere RC, Ma C, Cooper J. A Phase I dose‐escalation study of DCLL9718S, an antibody‐drug conjugate targeting C‐type lectin‐like molecule‐1 (CLL‐1) in patients with acute myeloid leukemia. American Journal Of Hematology 2021, 96: e175-e179. PMID: 33617672, PMCID: PMC8252033, DOI: 10.1002/ajh.26136.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodiesAntineoplastic AgentsChemical and Drug Induced Liver InjuryDose-Response Relationship, DrugEarly Termination of Clinical TrialsFemaleHumansImmunoconjugatesLectins, C-TypeLeukemia, Myeloid, AcuteMaleMiddle AgedMutationNeoplasm ProteinsNeoplasms, Second PrimaryReceptors, MitogenYoung Adult
2020
A case of acute myeloid leukemia with unusual germline CEBPA mutation: lessons learned about mutation detection, location, and penetrance
Mendoza H, Chen PH, Pine AB, Siddon AJ, Bale AE, Gowda L, Killie A, Richards J, Varin-Tremblay C, Kloss R, Podoltsev NA. A case of acute myeloid leukemia with unusual germline CEBPA mutation: lessons learned about mutation detection, location, and penetrance. Leukemia & Lymphoma 2020, 62: 1251-1254. PMID: 33345654, DOI: 10.1080/10428194.2020.1861276.Peer-Reviewed Case Reports and Technical NotesClinical outcomes and characteristics of patients with TP53-mutated acute myeloid leukemia or myelodysplastic syndromes: a single center experience*
Bewersdorf JP, Shallis RM, Gowda L, Wei W, Hager K, Isufi I, Kim TK, Pillai MM, Seropian S, Podoltsev NA, Gore SD, Siddon AJ, Zeidan AM. Clinical outcomes and characteristics of patients with TP53-mutated acute myeloid leukemia or myelodysplastic syndromes: a single center experience*. Leukemia & Lymphoma 2020, 61: 2180-2190. PMID: 32362171, PMCID: PMC7603787, DOI: 10.1080/10428194.2020.1759051.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaMedian overall survivalTherapy-related malignanciesOverall survivalMyelodysplastic syndromeMyeloid leukemiaAllogeneic hematopoietic stem cell transplantLonger median overall survivalSingle-center retrospective studyComplex karyotypeHematopoietic stem cell transplantIntensive chemotherapy approachesYale Cancer CenterCharacteristics of patientsSingle-center experienceMinority of patientsStem cell transplantLong-term survivalLow response rateIntensive chemotherapyCenter experienceClinicopathologic characteristicsAdverse prognosisAML patientsCell transplant
2015
The evolving field of prognostication and risk stratification in MDS: Recent developments and future directions
Lee EJ, Podoltsev N, Gore SD, Zeidan AM. The evolving field of prognostication and risk stratification in MDS: Recent developments and future directions. Blood Reviews 2015, 30: 1-10. PMID: 26119927, DOI: 10.1016/j.blre.2015.06.004.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsMyelodysplastic syndromeRisk stratificationRecurrent molecular mutationsRisk stratification toolRelevant clinical outcomesPrediction of outcomeRisk/benefit calculationsClinical courseClinical outcomesStratification toolMDS patientsPrognostication toolsIndividual patientsClinical practiceMolecular testingTherapeutic interventionsPatient careTherapeutic selectionPatientsMolecular mutationsIndependent impactPrognosticationBiological heterogeneityOutcomesReliable assay