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 survivalOutcomes of Patients with IDH1/2 Mutated Accelerated/Blast-Phase Myeloproliferative Neoplasms in the Era of IDH Inhibitors
Goldberg L, Yoon J, Johnston H, Davidson M, Siddon A, Shallis R, Chen E, Burkart M, Oh T, Iyer S, Madarang E, Muthiah C, Kassner J, Rampal R, Guru Murthy G, Bradley T, Abaza Y, Garcia J, Gupta V, Pettit K, Odenike O, Cursio J, Patel A. Outcomes of Patients with IDH1/2 Mutated Accelerated/Blast-Phase Myeloproliferative Neoplasms in the Era of IDH Inhibitors. Blood 2024, 144: 1787-1787. DOI: 10.1182/blood-2024-197898.Peer-Reviewed Original ResearchIsocitrate dehydrogenase inhibitorsMedian OSMPN-AP/BPIntensive chemotherapyMyeloproliferative neoplasmsHypomethylating agentsEuropean LeukemiaNetAcute myeloid leukemiaMPN-BPComplete remissionOverall survivalCytogenetic responsePartial remissionBlast phaseTen ptsCo-mutationsIncidence of driver mutationsVariable risk of progressionAchievement of complete remissionAllogeneic stem cell transplantationAssociated with poor overall survivalCohort of ptsIDH1 inhibitor ivosidenibIDH2 inhibitor enasidenibIncomplete count recoveryClinical Characteristics and Outcomes of Mixed Phenotype Acute Leukemia (MPAL): A Large Multi-Center Retrospective Study
Cohen-Nowak A, Coltoff A, Patel A, Atallah E, El Kettani M, Wang J, Symes E, Venkataraman G, Siddon A, Giever E, Shallis R, Altman J, Bell-Burdett K, Badar T, Aqil B, Abaza Y. Clinical Characteristics and Outcomes of Mixed Phenotype Acute Leukemia (MPAL): A Large Multi-Center Retrospective Study. Blood 2024, 144: 2801-2801. DOI: 10.1182/blood-2024-199377.Peer-Reviewed Original ResearchALL-directed therapySubtypes of acute leukemiaOverall survivalIntensive chemotherapyAcute lymphoblastic leukemiaAcute myeloid leukemiaAllo-SCTOS ratesAcute leukemiaFLT3-ITDBridge to allogeneic stem cell transplantationBlast populationCNS diseaseMedian duration of responseAllogeneic stem cell transplantationMulti-center retrospective studyResistant to traditional therapiesAML-directed therapyDiagnosis of MPALMedian overall survivalIncomplete count recoveryInduce durable remissionsDuration of responseStem cell transplantationAllo-SCT recipientsThe Prognostic and Predictive Value of RUNX1 Mutations in Newly Diagnosed Acute Myeloid Leukemia - an International Multicenter Cohort Study
Bystrom R, Bewersdorf J, Liu Y, Schaefer E, Shallis R, Boussi L, Zucenka A, Garciaz S, Aguirre L, DeAngelo D, Stone R, Luskin M, Garcia J, Winer E, Chen E, Wadleigh M, Ling K, Stein E, Goldberg A, Zeidan A, Shimony S, Stahl M. The Prognostic and Predictive Value of RUNX1 Mutations in Newly Diagnosed Acute Myeloid Leukemia - an International Multicenter Cohort Study. Blood 2024, 144: 2947-2947. DOI: 10.1182/blood-2024-205581.Peer-Reviewed Original ResearchAcute myeloid leukemiaComposite complete responseMedian OSRUNX1 mutationsComplete responseIntensive chemotherapyOverall survivalMyelodysplastic syndromeAllo-SCTIntermediate riskPredictive valueMyeloid leukemiaInternational multicenter retrospective cohort studyTreatment strategiesCohort studyNewly diagnosed acute myeloid leukemiaAllogeneic stem cell transplantationMulticenter retrospective cohort studyNext-generation sequencingAntecedent MDSConcomitant TP53 mutationIncomplete count recoveryTreated with ICStem cell transplantationAdverse risk featuresLeukemia Physician's Perspective on Transplant in Patients with TP53 Mutated Acute Myeloid Leukemia
Moreno Vanegas Y, El Khatib S, Hisrich B, Coltoff A, Shallis R, Patel A, Bewersdorf J, Oh T, Abaza Y, Foucar C, Goldberg A, Duvall A, Atallah E, Litzow M, Badar T. Leukemia Physician's Perspective on Transplant in Patients with TP53 Mutated Acute Myeloid Leukemia. Blood 2024, 144: 1487-1487. DOI: 10.1182/blood-2024-205782.Peer-Reviewed Original ResearchAcute myeloid leukemiaTP53-mAllo-HCTComplex cytogeneticsHypomethylating agentsInternational Consensus ClassificationRefractory diseaseSecondary AMLOverall survivalMyeloid leukemiaTP53-mutated acute myeloid leukemiaDe novo acute myeloid leukemiaProgressive acute myeloid leukemiaSecondary acute myeloid leukemiaAllogeneic hematopoietic cell transplantationMedian overall survivalTP53 allelic stateIncomplete count recoveryLow-intensity regimensReviewed electronic medical recordsHematopoietic cell transplantationRate of relapseMulticenter observational studyOverall response ratePatient selection criteriaImpact of Time from Diagnosis to Treatment on Outcomes of Adults with AML Treated with HMA and Venetoclax: A US-Based, Multi-Center, Real-World, Retrospective Analysis from the Consortium on Myeloid Malignancies and Neoplastic Diseases (COMMAND)
Yates S, Weiss J, Sneider A, Geramita E, Guru Murthy G, Badar T, Im A, Lin C, Cheng W, Winer E, Abaza Y, Litzow M, Atallah E, Swaroop A, Patel A, Shallis R. Impact of Time from Diagnosis to Treatment on Outcomes of Adults with AML Treated with HMA and Venetoclax: A US-Based, Multi-Center, Real-World, Retrospective Analysis from the Consortium on Myeloid Malignancies and Neoplastic Diseases (COMMAND). Blood 2024, 144: 447-447. DOI: 10.1182/blood-2024-207116.Peer-Reviewed Original ResearchDiagnosed AMLAcute myeloid leukemiaEuropean LeukemiaNetOverall survivalComplete responseECOG PSHypomethylating agentsSeverity of presentationMulti-centerPerformance statusRetrospective analysisFactors associated with improved OSTherapy-related acute myeloid leukemiaECOG PS of 2Initiation of induction therapyMultivariate analysisAssociated with worse OSNext generation sequencing panelIntermediate risk diseaseIncomplete count recoveryECOG performance statusDisease biologyNPM1 mutation statusUnivariate Cox modelPre-planned subgroup analysisClinical outcomes of hypomethylating agents plus Venetoclax as frontline treatment in patients 75 years and older with acute myeloid leukemia: Real‐world data from eight US academic centers
Abaza Y, Winer E, Murthy S, Shallis R, Matthews A, Badar T, Geramita E, Kota V, Swaroop A, Doukas P, Bradshaw D, Helenowski I, Liu Y, Zhang H, Im A, Litzow M, Perl A, Atallah E, Altman J. Clinical outcomes of hypomethylating agents plus Venetoclax as frontline treatment in patients 75 years and older with acute myeloid leukemia: Real‐world data from eight US academic centers. American Journal Of Hematology 2024, 99: 606-614. PMID: 38342997, DOI: 10.1002/ajh.27231.Peer-Reviewed Original ResearchAcute myeloid leukemiaHypomethylating agentsOverall survivalElderly patientsMedian OSMyeloid leukemiaTP53-mutated acute myeloid leukemiaNewly diagnosed acute myeloid leukemiaFailure of hypomethylating agentsMedian duration of responseDiagnosed AMLVIALE-A trialMedian overall survivalIncomplete count recoveryDuration of responseMulticenter retrospective studySingle-center studyTreatment of patientsStandard of careCR/CRi rateIntensive chemotherapyCount recoveryMedian durationFrontline treatmentRetrospective study
2023
Outcomes of Patients Receiving Intensive Therapy for Acute Myeloid Leukemia Relapsed after/Refractory to Frontline Less-Intensive Therapy
Achar R, McCormick B, Dworkin E, Geramita E, Im A, Patel A, Badar T, Shallis R. Outcomes of Patients Receiving Intensive Therapy for Acute Myeloid Leukemia Relapsed after/Refractory to Frontline Less-Intensive Therapy. Blood 2023, 142: 5859. DOI: 10.1182/blood-2023-179336.Peer-Reviewed Original ResearchOverall response rateAcute myeloid leukemiaMedian overall survivalMajority of ptsIntensive induction therapyIntensive therapyOverall survivalComplete remissionFrontline therapyR therapyInduction chemotherapyInduction therapyCPX-351Eastern Cooperative Oncology Group performance statusExact testResponse rateMorphologic leukemia-free stateR AMLRelapsed/refractory (R/R) diseaseHematopoietic stem cell transplantationCox proportional hazards modelContinuous variablesAdverse-risk diseaseIncomplete count recoveryIntensive induction chemotherapyWhat Is the Optimal Treatment Modality in Molecularly Defined Secondary AML? a Multicenter Cohort Study
Shimony S, Bewersdorf J, Shallis R, Liu Y, Schaefer E, Zeidan A, Goldberg A, Stein E, Marcucci G, Chen E, Ramos J, Lindsley R, Stein A, DeAngelo D, Neuberg D, Stone R, Ball B, Stahl M. What Is the Optimal Treatment Modality in Molecularly Defined Secondary AML? a Multicenter Cohort Study. Blood 2023, 142: 1478. DOI: 10.1182/blood-2023-172763.Peer-Reviewed Original ResearchAcute myeloid leukemiaComposite complete responseStem cell transplantationOverall survivalCPX-351Complete responseTreatment modalitiesMonosomal karyotypeCohort studyOdds ratioTreatment groupsLarge multicenter retrospective cohort studyMulticenter retrospective cohort studyAllogeneic stem cell transplantationSecondary acute myeloid leukemiaIncomplete count recoveryImproved overall survivalMedian overall survivalMulticenter cohort studyRetrospective cohort studyWorse overall survivalOptimal treatment modalityOptimal treatment selectionLog-rank testEffect of treatment
2020
Real-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 remission
2018
Characteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort
Stahl M, Wei W, Montesinos P, Lengline E, Shallis R, Neukirchen J, Bhatt V, Sekeres M, Fathi A, Konig H, Luger S, Khan I, Roboz G, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan J, Mukherjee S, Brunner A, Miller A, McMahon C, Ritchie E, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Cruz E, Rabinovich E, Yoo B, Podoltsev N, Gore S, Zeidan A. Characteristics, Treatment Patterns and Outcomes Among Newly Diagnosed Patients (pts) with Acute Myeloid Leukemia (AML) Who Present with Hyperleukocytosis: Findings from a Large International Patient Cohort. Blood 2018, 132: 4040. DOI: 10.1182/blood-2018-99-112974.Peer-Reviewed Original ResearchWhite blood cell countMedian overall survivalAcute myeloid leukemiaHematopoietic stem cell transplantIntensive chemotherapyTumor lysis syndromeOverall survivalTime of presentationComplete remissionAstex PharmaceuticalsSpeakers bureauPartial remissionTreatment patternsDaiichi SankyoJazz PharmaceuticalsCleveland Clinic Taussig Cancer InstituteJanssen PharmaceuticalsMedian white blood cell countHigher white blood cell countCelgene CorporationLong-term clinical outcomesAdvisory CommitteeImpact of leukapheresisIncomplete count recoveryMDS International Foundation