2024
Addition of Blinatumomab to Consolidation Therapy Among Older Newly Diagnosed Patients (pts) with BCR::ABL1 Negative B-Lineage Acute Lymphoblastic Leukemia (ALL) in the ECOG-ACRIN E1910 Randomized Phase III Trial
Podoltsev N, Sun Z, Litzow M, Paietta E, Roberts K, Zhang Y, Racevskis J, Lazarus H, Rowe J, Arber D, Wieduwilt M, Liedtke M, Bergeron J, Wood B, Zhao Y, Wu G, Chang T, Zhang W, Pratz K, Dinner S, Frey N, Gore S, Bhatnagar B, Atallah E, Uy G, Jeyakumar D, Lin T, Willman C, DeAngelo D, Patel S, Elliott M, Advani A, Tzachanis D, Vachhani P, Roy R, Sharon E, Little R, Erba H, Stone R, Mullighan C, Tallman M, Luger S, Mattison R. Addition of Blinatumomab to Consolidation Therapy Among Older Newly Diagnosed Patients (pts) with BCR::ABL1 Negative B-Lineage Acute Lymphoblastic Leukemia (ALL) in the ECOG-ACRIN E1910 Randomized Phase III Trial. Blood 2024, 144: 4211-4211. DOI: 10.1182/blood-2024-207143.Peer-Reviewed Original ResearchHematopoietic stem cell transplantationRelapse free survivalAcute lymphoblastic leukemiaWhite blood cell countOlder ptsOverall survivalBone marrowAllogeneic hematopoietic stem cell transplantationB-lineage acute lymphoblastic leukemiaRandomized phase III trialFlow cytometryMulti-color flow cytometryStratified multivariable Cox modelsIncreased treatment toxicityPeripheral blood blastsStratified log-rank testImprovement of OSHigh dose methotrexateImproved overall survivalMedian follow-upStem cell transplantationKaplan-Meier methodPhase III trialsEstimates of OSLog-rank testCost-Effectiveness of Allogeneic Hematopoietic Stem Cell Transplantation Versus Consolidation Chemotherapy for Patients with Intermediate Risk Acute Myeloid Leukemia
Alhajahjeh A, Patel K, Shallis R, Podoltsev N, Kewan T, Stempel J, Mendez L, Huntington S, Stahl M, Zeidan A, Goshua G, Bewersdorf J. Cost-Effectiveness of Allogeneic Hematopoietic Stem Cell Transplantation Versus Consolidation Chemotherapy for Patients with Intermediate Risk Acute Myeloid Leukemia. Blood 2024, 144: 788. DOI: 10.1182/blood-2024-201535.Peer-Reviewed Original ResearchHematopoietic stem cell transplantationUpfront hematopoietic stem cell transplantationDisease-free survivalAcute myeloid leukemiaIntermediate risk acute myeloid leukemiaConsolidation chemotherapyCurative therapeutic modalityOverall survivalOne-way sensitivity analysesEuropean LeukemiaNetIncremental net monetary benefitMyeloid leukemiaMortality associated with hematopoietic stem cell transplantationCost-effective strategyTherapeutic modalitiesFavorable risk AMLSalvage hematopoietic stem cell transplantationAllogeneic hematopoietic stem cell transplantationCycles of consolidation chemotherapyUS health system perspectiveDiagnosed AMLFollow-up of patientsSurvival analysisHigh-dose cytarabineLines of therapyCost-Effectiveness of Eltrombopag Plus Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone in Adults with Severe Aplastic Anemia in the United States
Potnis K, Ito S, Patel K, Shallis R, Podoltsev N, Kewan T, Stempel J, Mendez L, Huntington S, Stahl M, Zeidan A, Bewersdorf J, Goshua G. Cost-Effectiveness of Eltrombopag Plus Immunosuppressive Therapy Versus Immunosuppressive Therapy Alone in Adults with Severe Aplastic Anemia in the United States. Blood 2024, 144: 3644. DOI: 10.1182/blood-2024-204312.Peer-Reviewed Original ResearchSevere aplastic anemiaTreatment of severe aplastic anemiaQuality-adjusted life yearsAplastic anemiaIncremental net monetary benefitDeterministic sensitivity analysisProbabilistic sensitivity analysesImmunosuppressive therapyNewly diagnosed severe aplastic anemiaCost-effectiveness of eltrombopagOral thrombopoietin receptor agonistPatients treated with eltrombopagUntreated severe aplastic anemiaHematopoietic stem cell transplantationCost-effective therapeutic strategyDevelopment of adverse eventsLonger-term follow-up dataRACE trialsLater-line therapyThrombopoietin receptor agonistsPhase I/II trialSecond-line therapyStem cell transplantationU.S. payer perspectiveFirst-line treatment
2022
Outcomes in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy
Perl A, Larson R, Podoltsev N, Strickland S, Wang E, Atallah E, Schiller G, Martinelli G, Neubauer A, Sierra J, Montesinos P, Recher C, Yoon S, Maeda Y, Hosono N, Onozawa M, Kato T, Kim H, Hasabou N, Nuthethi R, Tiu R, Levis M. Outcomes in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy. Transplantation And Cellular Therapy 2022, 29: 265.e1-265.e10. PMID: 36526260, PMCID: PMC10189888, DOI: 10.1016/j.jtct.2022.12.006.Peer-Reviewed Original ResearchConceptsHematopoietic stem cell transplantationAcute myelogenous leukemiaPost-transplantation maintenance therapyLower relapse rateAdverse eventsADMIRAL trialMaintenance therapyPost-transplantation survivalGilteritinib armRelapse rateSalvage chemotherapyMyelogenous leukemiaRefractory acute myelogenous leukemiaTreatment-emergent adverse eventsFLT3 internal tandem duplication (ITD) mutationsCommon adverse eventsComposite complete remissionGlobal phase 3Incidence of gradePost-transplantation complicationsTransplantation-eligible patientsAlanine aminotransferase levelsHigher remission ratesOverall survival rateSurvival of patients
2021
Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation–A Systematic Review and Meta-Analysis
Bewersdorf JP, Allen C, Mirza AS, Grimshaw AA, Giri S, Podoltsev NA, Gowda L, Cho C, Tallman MS, Zeidan AM, Stahl M. Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation–A Systematic Review and Meta-Analysis. Transplantation And Cellular Therapy 2021, 27: 997.e1-997.e11. PMID: 34551341, PMCID: PMC9533376, DOI: 10.1016/j.jtct.2021.09.005.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaRelapse-free survivalMaintenance therapyMyelodysplastic syndromeFLT3 inhibitorsAllo-HCTHazard ratioMaintenance treatmentClinical trialsMyeloid leukemiaAllogeneic hematopoietic stem cell transplantationControl groupSystematic reviewAllogeneic hematopoietic cell transplantMeasurable residual disease statusHematopoietic stem cell transplantationMeasurable residual disease testingNon-relapse mortalityHematopoietic cell transplantPre-emptive treatmentResidual disease statusStem cell transplantationFavorable safety profileSame patient cohortRandom-effects modelMulti-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 salvage
2020
Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia
Badar T, Szabo A, Dinner S, Liedtke M, Burkart M, Shallis RM, Yurkiewicz IR, Kuo E, Khan MA, Balasubramanian S, Yang J, Hefazi M, Podoltsev N, Patel A, Curran E, Wang A, Arslan S, Aldoss I, Siebenaller C, Mattison RJ, Litzow MR, Wadleigh M, Advani AS, Atallah E. Sequencing of novel agents in relapsed/refractory B‐cell acute lymphoblastic leukemia: Blinatumomab and inotuzumab ozogamicin may have comparable efficacy as first or second novel agent therapy in relapsed/refractory acute lymphoblastic leukemia. Cancer 2020, 127: 1039-1048. PMID: 33259056, DOI: 10.1002/cncr.33340.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntibodies, BispecificAntineoplastic Agents, ImmunologicalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHematopoietic Stem Cell TransplantationHumansInotuzumab OzogamicinMaleMiddle AgedPrecursor Cell Lymphoblastic Leukemia-LymphomaRemission InductionRetrospective StudiesTreatment OutcomeWithholding TreatmentYoung AdultConceptsAcute lymphoblastic leukemiaRefractory B-cell acute lymphoblastic leukemiaB-cell acute lymphoblastic leukemiaMedian overall survivalINO groupNovel agentsOverall survivalLymphoblastic leukemiaComplete remissionInotuzumab ozogamicinNA therapyComparable efficacyRelapsed/refractory (r/r) B-cell acute lymphoblastic leukemiaAllogeneic hematopoietic stem cell transplantationCR/CRi rateIncomplete count recovery (CRi) ratesRefractory acute lymphoblastic leukemiaHematopoietic stem cell transplantationNovel agent therapyOutcomes of patientsStem cell transplantationBlinatumomab groupCRi rateTreatment discontinuationAdverse eventsReal-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 MR, Kuo E, Wang A, Curran E, Shallis RM, 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. Clinical Lymphoma Myeloma & Leukemia 2020, 20: 556-560.e2. PMID: 32291234, DOI: 10.1016/j.clml.2020.03.004.Peer-Reviewed Original ResearchConceptsB-cell acute lymphocytic leukemia patientsAcute lymphocytic leukemia patientsAllo-HCTLymphocytic leukemia patientsInotuzumab ozogamicinOverall survivalLeukemia patientsAllogeneic hematopoietic stem cell transplantationMinimal residual disease negativityHematopoietic stem cell transplantationCommon grade 3Efficacy of iNOHigher adverse eventsMedian overall survivalMulticenter cohort analysisVeno-occlusive diseaseDuration of responseStem cell transplantationOverall response rateINO initiationComplete remissionMedian durationAdverse eventsMedian ageCumulative dose
2018
Allogeneic Hematopoietic Stem Cell Transplantation Following the Use of Hypomethylating Agents among Patients with Relapsed or Refractory AML: Findings from an International Retrospective Study
Stahl M, DeVeaux M, Montesinos P, Itzykson R, Ritchie EK, Sekeres MA, Majhail N, Barnard J, Podoltsev NA, Brunner AM, Komrokji RS, Bhatt VR, Al-Kali A, Cluzeau T, Santini V, Roboz GJ, Fenaux P, Litzow M, Fathi AT, Perreault S, Kim TK, Prebet T, Vey N, Verma V, Kobbe G, Bergua J, Serrano J, Gore SD, Zeidan AM. Allogeneic Hematopoietic Stem Cell Transplantation Following the Use of Hypomethylating Agents among Patients with Relapsed or Refractory AML: Findings from an International Retrospective Study. Transplantation And Cellular Therapy 2018, 24: 1754-1758. PMID: 29649620, DOI: 10.1016/j.bbmt.2018.03.025.Peer-Reviewed Original ResearchConceptsHematopoietic stem cell transplantationAllogeneic hematopoietic stem cell transplantationHMA therapyStem cell transplantationComplete remissionCell transplantationUnrelated hematopoietic stem cell transplantationInternational retrospective studyLimited treatment optionsAcute myeloid leukemiaChronic GVHDMedian OSPrimary refractoryRR-AMLConditioning regimenRefractory AMLPatients patientsUnrelated donorsEntire cohortPoor prognosisRetrospective studyTreatment optionsMyeloid leukemiaInternational cohortHypomethylating agent