2024
Analyzing determinants of premature trial discontinuation in leukemia clinical trials
Rotter L, Alhajahjeh A, Stempel J, Grimshaw A, Bewersdorf J, Blaha O, Kewan T, Podoltsev N, Shallis R, Mendez L, Stahl M, Zeidan A. Analyzing determinants of premature trial discontinuation in leukemia clinical trials. Leukemia & Lymphoma 2024, ahead-of-print: 1-9. PMID: 39440622, DOI: 10.1080/10428194.2024.2416565.Peer-Reviewed Original ResearchClinical trialsSlow accrualLeukemia trialsEarly-phase trialsNon-randomized trialsAcademic-sponsored trialsImprove patient outcomesLeukemia clinical trialsSingle-centerTrial discontinuationSponsored trialsSmall trialsLeukemiaEarly terminationPatient outcomesLate-phaseIndependent reviewersTermination ratesComprehensive searchTrials
2023
Intensive Induction Chemotherapy Vs Hypomethylating Agents + Venetoclax (HMA/VEN) in NPM1-Mutant Newly Diagnosed Acute Myeloid Leukemia (AML) - a Multicenter Cohort Study
Bewersdorf J, Shimony S, Shallis R, Liu Y, Schaefer E, Zeidan A, Goldberg A, Stein E, Marcucci G, Lindsley R, Chen E, Ramos J, Stein A, DeAngelo D, Neuberg D, Stone R, Ball B, Stahl M. Intensive Induction Chemotherapy Vs Hypomethylating Agents + Venetoclax (HMA/VEN) in NPM1-Mutant Newly Diagnosed Acute Myeloid Leukemia (AML) - a Multicenter Cohort Study. Blood 2023, 142: 2964. DOI: 10.1182/blood-2023-174285.Peer-Reviewed Original ResearchNPM1 mutant acute myeloid leukemiaIntensive induction chemotherapyAcute myeloid leukemiaComposite complete responseMedian overall survivalOverall survivalComplete responseAllo-SCTPt ageAbnormal cytogeneticsCohort studyMyelodysplastic syndromePolymerase chain reactionClinical trialsMyeloid leukemiaNPM1 mutationsLarge multicenter retrospective cohort studyTime-varying covariatesMulticenter retrospective cohort studyAllogeneic stem cell transplantationPrior myelodysplastic syndromeMulticenter cohort studyRetrospective cohort studyStem cell transplantationPrior chemotherapy exposure
2021
Multi-institutional study evaluating clinical outcome with allogeneic hematopoietic stem cell transplantation after blinatumomab in patients with B-cell acute lymphoblastic leukemia: real-world data
Badar T, Szabo A, Litzow M, Burkart M, Yurkiewicz I, Dinner S, Hefazi M, Shallis RM, Podoltsev N, Patel AA, Curran E, Wadleigh M, Balasubramanian S, Yang J, Arslan S, Aldoss I, Mattison R, Cenin D, Siebenaller C, Advani A, Liedtke M, Atallah E. Multi-institutional study evaluating clinical outcome with allogeneic hematopoietic stem cell transplantation after blinatumomab in patients with B-cell acute lymphoblastic leukemia: real-world data. Bone Marrow Transplantation 2021, 56: 1998-2004. PMID: 33824440, DOI: 10.1038/s41409-021-01279-w.Peer-Reviewed Original ResearchConceptsOverall survivalCumulative incidenceAllogeneic hematopoietic stem cell transplantationB-cell acute lymphoblastic leukemiaHematopoietic stem cell transplantationAcute lymphocytic leukemia patientsStem cell transplantationAcute lymphoblastic leukemiaLymphocytic leukemia patientsMulti-institutional studyReal-world analysisSevere cGVHDFree survivalClinical outcomesCell transplantationLymphoblastic leukemiaMulti-center dataClinical trialsAlloHCTLeukemia patientsBlinatumomabPatientsSurvivalIncidenceSubsequent salvageThe 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
2020
Complete, yet partial: the benefits of complete response with partial haematological recovery as an endpoint in acute myeloid leukaemia clinical trials
Shallis RM, Pollyea DA, Zeidan AM. Complete, yet partial: the benefits of complete response with partial haematological recovery as an endpoint in acute myeloid leukaemia clinical trials. The Lancet Haematology 2020, 7: 853-856. PMID: 33242436, DOI: 10.1016/s2352-3026(20)30352-5.Peer-Reviewed Original ResearchReal-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with blinatumomab
Badar T, Szabo A, Advani A, Wadleigh M, Arslan S, Khan MA, Aldoss I, Siebenaller C, Schultz E, Hefazi M, Shallis RM, Yurkiewicz I, Podoltsev N, Patel AA, Curran E, Balasubramanian S, Yang J, Mattison RJ, Burkart M, Dinner S, Liedtke M, Litzow MR, Atallah E. Real-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with blinatumomab. Blood Advances 2020, 4: 2308-2316. PMID: 32453836, PMCID: PMC7252553, DOI: 10.1182/bloodadvances.2019001381.Peer-Reviewed Original ResearchConceptsMedian relapse-free survivalAllogeneic hematopoietic cell transplantationHematopoietic cell transplantationRelapse-free survivalAcute lymphoblastic leukemiaOverall survivalCell transplantationRR diseaseClinical trialsComplete remission/complete remissionRetrospective multicenter cohort analysisB-cell acute lymphoblastic leukemiaB-cell acute lymphocytic leukemia patientsCytokine release syndromeIncomplete count recoveryMulticenter cohort analysisAcute lymphocytic leukemia patientsFavorable prognostic significanceLymphocytic leukemia patientsReal-world outcomesConsolidation therapyMRD negativityPrior therapyRelease syndromeComplete remissionImmune checkpoint inhibition in myeloid malignancies: Moving beyond the PD-1/PD-L1 and CTLA-4 pathways
Bewersdorf JP, Shallis RM, Zeidan AM. Immune checkpoint inhibition in myeloid malignancies: Moving beyond the PD-1/PD-L1 and CTLA-4 pathways. Blood Reviews 2020, 45: 100709. PMID: 32487480, DOI: 10.1016/j.blre.2020.100709.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsImmune checkpoint inhibitorsMyeloid malignanciesPD-1/PD-L1CTLA-4 pathwayImmune checkpoint inhibitionAcute myeloid leukemiaSafe combination therapyICI therapyImmunologic landscapeCheckpoint inhibitorsDisease coursePD-L1Checkpoint inhibitionMyelodysplastic syndromeCombination therapyMechanisms of resistanceClinical trialsMyeloid leukemiaClinical developmentPotential biomarkersNovel targetPatientsMalignancyTherapyBiomarkers
2019
The minimal that kills: Why defining and targeting measurable residual disease is the “Sine Qua Non” for further progress in management of acute myeloid leukemia
Bewersdorf JP, Shallis RM, Boddu PC, Wood B, Radich J, Halene S, Zeidan AM. The minimal that kills: Why defining and targeting measurable residual disease is the “Sine Qua Non” for further progress in management of acute myeloid leukemia. Blood Reviews 2019, 43: 100650. PMID: 31883804, DOI: 10.1016/j.blre.2019.100650.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaMyeloid leukemiaHard clinical outcomesClinical trial evidenceMeasurable residual diseaseResidual leukemic cellsRisk of relapseApprovable endpointsMRD statusDeep remissionMorphologic remissionMRD assessmentOverall survivalMRD levelsClinical outcomesDisease relapseInitial treatmentResidual diseaseTrial evidenceClinical trialsTreatment decisionsSurrogate endpointsBone marrowPreemptive interventionLeukemic cellsHedgehog pathway inhibition as a therapeutic target in acute myeloid leukemia
Shallis RM, Bewersdorf JP, Boddu PC, Zeidan AM. Hedgehog pathway inhibition as a therapeutic target in acute myeloid leukemia. Expert Review Of Anticancer Therapy 2019, 19: 717-729. PMID: 31422721, DOI: 10.1080/14737140.2019.1652095.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaHh pathway inhibitorsMyeloid leukemiaSurvival of AMLPathway inhibitorHh pathwayPoor-risk diseaseHedgehog pathway inhibitionStem cellsCombination therapyClinical trialsFirst approvalTherapeutic strategiesTherapeutic targetPathway inhibitionHematopoietic stem cellsNeoplasm therapyOlder populationTherapyHedgehog pathwayFurther studiesLeukemiaNormal hematopoiesisAdult stem cellsInhibitorsEpigenetic therapy combinations in acute myeloid leukemia: what are the options?
Bewersdorf JP, Shallis R, Stahl M, Zeidan AM. Epigenetic therapy combinations in acute myeloid leukemia: what are the options? Therapeutic Advances In Hematology 2019, 10: 2040620718816698. PMID: 30719265, PMCID: PMC6348528, DOI: 10.1177/2040620718816698.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsAcute myeloid leukemiaCombination therapyTherapy combinationsMyeloid leukemiaEpigenetic therapyAdvanced clinical testingTherapeutic optionsClinical trialsConventional chemotherapyClinical dataPreclinical studiesAML pathogenesisClinical practiceSingle agentClinical testingTherapyLeukemic pathogenesisDriver mutationsDNA methylationHistone methylation inhibitorPathogenesisLeukemiaDehydrogenase inhibitorEpigenetic alterationsActual DNA sequence
2018
More is less, less is more, or does it really matter? The curious case of impact of azacitidine administration schedules on outcomes in patients with myelodysplastic syndromes
Shallis RM, Zeidan AM. More is less, less is more, or does it really matter? The curious case of impact of azacitidine administration schedules on outcomes in patients with myelodysplastic syndromes. BMC Hematology 2018, 18: 4. PMID: 29435332, PMCID: PMC5796398, DOI: 10.1186/s12878-018-0095-2.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsHigh-risk myelodysplastic syndromeMyelodysplastic syndromeAcute myeloid leukemiaAdministration scheduleOverall survivalLower-risk myelodysplastic syndromesAlternative administration schedulesOutcomes of patientsAlternative dosing schedulesRisk of progressionMeaningful clinical responsesAgent azacitidineAZA-001Clinical responseConventional careDosing schedulesPeripheral cytopeniasProspective studyClinical trialsHematologic disordersMyeloid leukemiaMost trialsResponse ratePatientsSystematic review
2017
Day 14 bone marrow examination in the management of acute myeloid leukemia
Terry CM, Shallis RM, Estey E, Lim SH. Day 14 bone marrow examination in the management of acute myeloid leukemia. American Journal Of Hematology 2017, 92: 1079-1084. PMID: 28612456, DOI: 10.1002/ajh.24818.Peer-Reviewed Original ResearchConceptsDay 14 bone marrowBlast cell countNational Comprehensive Cancer NetworkBone marrow examinationInduction therapyBone marrowCell countMarrow examinationSecond induction therapyLonger hospital stayTreatment-related mortalityComprehensive Cancer NetworkManagement of patientsBone marrow evaluationAcute myeloid leukemiaFurther chemotherapyComplete remissionHospital stayIntravenous antimicrobialsMarrow evaluationClinical trialsBlood productsMyeloid leukemiaHigh riskDay 28