2024
Efficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2)
Stempel J, Uy G, Dinner S, Gojo I, Reed D, Roy R, Byrd K, Yerrabothala S, Lai C, Doucette K, Caldwell A, Blaha O, Podoltsev N, Mendez L, Bewersdorf J, Kewan T, Wistuba I, Alatrash G, Haymaker C, Streicher H, Sharon E, Little R, Gore S, Radich J, Wood B, Zeidan A, Shallis R. Efficacy and Safety of Pembrolizumab Added to Azacitidine Plus Venetoclax for Patients with Acute Myeloid Leukemia: Results from an Investigator-Initiated, Multi-Center, CTEP-Sponsored Randomized, Phase II Trial (BLAST AML-2). Blood 2024, 144: 736. DOI: 10.1182/blood-2024-210370.Peer-Reviewed Original ResearchPhase II trialTreatment-related AEsII trialFrequent treatment-related AEsSafety run-in periodAllogeneic stem cell transplantationNo dose limiting toxicitiesRandomized phase II trialAML-2Multi-centerControl armSafety of pembrolizumabDose-limiting toxicityPD-1 inhibitionAnti-PD1 antibodyIncomplete count recoveryFLT3 wild-typeIntermediate cytogenetic riskStem cell transplantationAcute myeloid leukemiaActivated T cellsRun-in periodIntention-to-treat analysisCancer Immune MonitoringLong-term survivalToxicity and Efficacy of Isavuconazole Vs Voriconazole As Anti-Fungal Prophylaxis for Patients with Acute Myeloid Leukemia
Hunter C, Bewersdorf J, Mendez L, Podoltsev N, Zeidan A, Eighmy W, Roeder H, Malinis M, Shallis R. Toxicity and Efficacy of Isavuconazole Vs Voriconazole As Anti-Fungal Prophylaxis for Patients with Acute Myeloid Leukemia. Blood 2024, 144: 1480-1480. DOI: 10.1182/blood-2024-211250.Peer-Reviewed Original ResearchInvasive fungal infectionsAcute myeloid leukemiaAntifungal prophylaxisDiagnosed AMLDrug-drug interactionsTransaminase elevationVisual disturbancesRates of invasive fungal infectionsInvasive fungal infections incidenceBaseline ANCCD4 countMyeloid leukemiaAllogeneic stem cell transplantationAnti-fungal prophylaxisAcute myeloid leukemia diagnosisDuration of neutropeniaBaseline CD4 countLess-intensive therapyStem cell transplantationPatient baseline characteristicsSide effect profileCandida sppTriazole agentsWilcoxon rank sum testAntifungal voriconazoleRisk Factors and Predictors of Outcomes after Invasive Fungal Infection Among Patients with Acute Myeloid Leukemia
Hunter C, Bewersdorf J, Mendez L, Podoltsev N, Zeidan A, Eighmy W, Roeder H, Malinis M, Shallis R. Risk Factors and Predictors of Outcomes after Invasive Fungal Infection Among Patients with Acute Myeloid Leukemia. Blood 2024, 144: 4253. DOI: 10.1182/blood-2024-211426.Peer-Reviewed Original ResearchInvasive fungal infection diagnosisInvasive fungal infectionsAcute myeloid leukemiaInvasive Fungal Infection GroupAntifungal prophylaxis agentAntifungal prophylaxisCases of invasive fungal infectionsRates of invasive fungal infectionsFungal infectionsMyeloid leukemiaPrevent invasive fungal infectionsMycoses Study Group Education and Research ConsortiumRate of mortalityIFI patientsAllogeneic stem cell transplantationRisk factorsConsensus definitionAssociated with early mortalityNon-IFI groupSingle-gene mutationsPeriod of neutropeniaDays of neutropeniaAcute myeloid leukemia subtypesStem cell transplantationKaplan-Meier method
2020
Cui bono? Finding the value of allogeneic stem cell transplantation for lower-risk myelodysplastic syndromes
Shallis RM, Podoltsev NA, Gowda L, Zeidan AM, Gore SD. Cui bono? Finding the value of allogeneic stem cell transplantation for lower-risk myelodysplastic syndromes. Expert Review Of Hematology 2020, 13: 447-460. PMID: 32182435, DOI: 10.1080/17474086.2020.1744433.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAllogeneic stem cell transplantationStem cell transplantationAcute myeloid leukemiaMyelodysplastic syndromeMDS patientsRisk stratificationCell transplantationPrognostic toolLower-risk myelodysplastic syndromesHigh-risk myelodysplastic syndromeLow-risk MDS patientsSevere bone marrow failureLow-risk diseaseLow-risk patientsOnly curative optionPrognosis of patientsBone marrow failureAggressive therapyCurative optionPrognostic impactEtiologic roleDisease progressionMyeloid leukemiaAlloSCTPatients
2019
Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Inotuzumab Ozogamicin
Badar T, Szabo A, Wadleigh M, Liedtke M, Arslan S, Siebenaller C, Aldoss I, Schultz E, Hefazi M, Litzow M, Kuo E, Wang A, Curran E, Shallis R, Podoltsev N, Balasubramanian S, Yang J, Mattison R, Burkart M, Dinner S, Advani A, Atallah E. Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Inotuzumab Ozogamicin. Blood 2019, 134: 1302. DOI: 10.1182/blood-2019-124882.Peer-Reviewed Original ResearchMedian overall survivalDuration of responseAllo-HCTOverall survivalAcute lymphocytic leukemiaTyrosine kinase inhibitorsComplete remissionB cellsInotuzumab ozogamicinAdverse eventsRefractory B-cell acute lymphocytic leukaemiaJazz PharmaceuticalsResponse rateB-cell acute lymphocytic leukemiaMinimal residual disease negativityAllogeneic stem cell transplantationAdvisory CommitteeB-cell acute lymphocytic leukemia patientsEfficacy of iNOGenentech/RocheIncomplete count recoveryMedian response durationVeno-occlusive diseaseOutcomes of patientsKaplan-Meier methodReal World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Blinatumomab
Badar T, Szabo A, Advani A, Wadleigh M, Arslan S, Khan M, Aldoss I, Siebenaller C, Schultz E, Hefazi M, Shallis R, Yurkiewicz I, Podoltsev N, Patel A, Curran E, Balasubramanian S, Yang J, Mattison R, Burkart M, Dinner S, Liedtke M, Litzow M, Atallah E. Real World Outcomes of Adult B-Cell Acute Lymphocytic Leukemia Patients Treated with Blinatumomab. Blood 2019, 134: 3809. DOI: 10.1182/blood-2019-125466.Peer-Reviewed Original ResearchCytokine release syndromeDuration of responseMinimal residual diseaseMedian overall survivalMedian DOROverall survivalTyrosine kinase inhibitorsAllo-HCTMRD negativityComplete remissionB cellsRR diseaseClinical trialsJazz PharmaceuticalsAcute lymphocytic leukemia blastsPhiladelphia chromosome-positive diseaseAllogeneic stem cell transplantationAdvisory CommitteePositive cytotoxic T cellsB-cell acute lymphocytic leukemia patientsCR/CRiEfficacy of blinatumomabG3-4 toxicitiesGenentech/RocheIncomplete count recovery
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