2021
Clinical Experience in the Randomized Phase 3 Sierra Trial: Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Patients with Active, Relapsed/Refractory AML Not Responding to Targeted Therapies
Gyurkocza B, Nath R, Seropian S, Choe H, Litzow M, Koshy N, Stiff P, Abboud C, Tomlinson B, Abhyankar S, Hari P, Al-Kadhimi Z, Chen G, Sabloff M, Orozco J, Foran J, Kebriaei P, Jamieson K, Magalhaes-Silverman M, van Besien K, Schuster M, Law A, Levy M, Lazarus H, Giralt S, Berger M, Spross J, Desai A, Reddy V, Pagel J. Clinical Experience in the Randomized Phase 3 Sierra Trial: Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Conditioning Enables Hematopoietic Cell Transplantation with Successful Engraftment and Acceptable Safety in Patients with Active, Relapsed/Refractory AML Not Responding to Targeted Therapies. Blood 2021, 138: 1791. DOI: 10.1182/blood-2021-148497.Peer-Reviewed Original ResearchHematopoietic cell transplantAcute myeloid leukemiaR AMLAllogeneic hematopoietic cell transplantComplete remissionMedian radiation doseBristol-Myers SquibbCC patientsTargeted therapyFebrile neutropeniaFLT-3 inhibitorsCurrent equity holderSpeakers bureauConventional careMedian timeBcl-2 inhibitorsIDH inhibitorsRelapsed/Refractory Acute Myeloid LeukemiaIncidence of FNRefractory acute myeloid leukemiaAdvisory CommitteePrincipal investigatorSeattle GeneticsIncidence of gradeIncidence of sepsis59 Myeloablative Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Spares the GI Tract and Has Low Incidence of Severe Mucositis, Febrile Neutropenia and Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Nath R, Gyurkocza B, Choe H, Seropian S, Stiff P, Agura E, Abhyankar S, Litzow M, Tomlinson B, Abboud C, Chen G, Hari P, Orozco J, Sabloff M, Al-Kadhimi Z, Van Besien K, Silverman M, Foran J, Schuster M, Kebriaei P, Levy M, Lazarus H, Giralt S, Liang Q, Berger M, Reddy V, Pagel J. 59 Myeloablative Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Spares the GI Tract and Has Low Incidence of Severe Mucositis, Febrile Neutropenia and Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML). Transplantation And Cellular Therapy 2021, 27: s56. DOI: 10.1016/s2666-6367(21)00085-3.Peer-Reviewed Original Research
2020
574. De-escalation of Broad Spectrum Antibiotics during Cytokine Release Syndrome with Haploidentical Hematopoietic Stem Cell Transplantation
Schiffer M, Perreault S, McManus D, Foss F, Gowda L, Isufi I, Seropian S, Topal J. 574. De-escalation of Broad Spectrum Antibiotics during Cytokine Release Syndrome with Haploidentical Hematopoietic Stem Cell Transplantation. Open Forum Infectious Diseases 2020, 7: s352-s352. PMCID: PMC7776323, DOI: 10.1093/ofid/ofaa439.768.Peer-Reviewed Original ResearchCytokine release syndromeHaploidentical hematopoietic stem cell transplantationHematopoietic stem cell transplantationFebrile neutropeniaHaplo-HSCTStem cell transplantationRelease syndromeBreakthrough infectionsCell transplantationRecurrent feverEmpiric broad-spectrum antibiotic therapyRates of FNBroad-spectrum antibiotic therapyMulti-drug resistant organismsHaplo-HSCT patientsNon-infectious complicationsPost-transplant cyclophosphamideStem cell infusionBlood culture dataPositive blood culturesBroad-spectrum antibioticsYale New Haven HealthBackground FeverAntibacterial prophylaxisSecondary endpointsHigh Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia
Gyurkocza B, Nath R, Choe H, Seropian S, Stiff P, Abhyankar S, Agura E, Litzow M, Tomlinson B, Chen G, Hari P, Orozco J, Al-Kadhimi Z, Abboud C, Van Besien K, Sabloff M, Magalhaes-Silverman M, Foran J, Schuster M, Kebriaei P, Levy M, Lazarus H, Giralt S, Liang Q, Berger M, Reddy V, Pagel J. High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia. Blood 2020, 136: 30-31. DOI: 10.1182/blood-2020-134624.Peer-Reviewed Original ResearchHematopoietic cell transplantationAcute myeloid leukemiaCurrent equity holderR AMLFebrile neutropeniaTherapeutic doseGI tractBone marrowConventional careOlder patientsMyeloid leukemiaRefractory (R/R) AMLHigh-risk acute myeloid leukemiaLow-dose total body irradiationHigh dosesRadiation doseMyeloablative hematopoietic cell transplantationRefractory acute myeloid leukemiaAllogeneic hematopoietic cell transplantationAdvisory CommitteeAEs of interestIncidence of mucositisRate of mucositisInitiation of therapyMedian radiation doseAML-123: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Engraftment in Older Patients with Active, Relapsed, or Refractory (rel/ref) AML: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, Van Besien K, Sabloff M, Kebriaei P, Abboud C, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. AML-123: Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Engraftment in Older Patients with Active, Relapsed, or Refractory (rel/ref) AML: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 SIERRA Trial. Clinical Lymphoma Myeloma & Leukemia 2020, 20: s182. DOI: 10.1016/s2152-2650(20)30716-3.Peer-Reviewed Original ResearchCC armOlder patientsTransplant ratesLower transplant-related mortalityIncidence of gradeNon-relapse mortalityTransplant-related mortalityMajority of patientsFavorable safety profileFebrile neutropeniaInduction therapyPrior therapyActive diseaseRefractory AMLSalvage therapyDurable responsesGraft failureInfusion reactionsEngraftment dataMedian ageSafety profilePatient populationAdvanced ageDisease progressionGrade 3Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, van Besien K, Sabloff M, Kebriaei P, Abboud C, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Allogeneic Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial. Transplantation And Cellular Therapy 2020, 26: s32-s33. DOI: 10.1016/j.bbmt.2019.12.575.Peer-Reviewed Original ResearchHematopoietic cell transplantationSalvage therapyOlder patientsCC armConventional careCC patientsConventional hematopoietic cell transplantationGrade 3 febrile neutropeniaAllogeneic hematopoietic cell transplantationPre-treated patientsPhase 3 trialFailure of chemotherapyYears of ageFebrile neutropeniaInduction therapyActive diseaseMyeloablative conditioningRefractory AMLBackground PatientsBM blastsInfusion reactionsMethods PatientsTransplant candidatesAllogeneic transplantationCurative therapy
2019
Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial
Gyurkocza B, Nath R, Stiff P, Agura E, Litzow M, Tomlinson B, Choe H, Abhyankar S, Seropian S, Chen G, Hari P, Al-Kadhimi Z, Foran J, Orozco J, Van Besien K, Sabloff M, Kebriaei P, Levy M, Lazarus H, Giralt S, Berger M, Reddy V, Pagel J. Re-Induction and Targeted Conditioning with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Leads to High Rates of Transplantation and Successful Engraftment in Older Patients with Active, Relapsed or Refractory (rel/ref) AML after Failure of Chemotherapy and Targeted Agents: Preliminary Midpoint Results from the Prospective, Randomized Phase 3 Sierra Trial. Blood 2019, 134: 5642. DOI: 10.1182/blood-2019-122776.Peer-Reviewed Original ResearchHematopoietic cell transplantationComplete remissionSalvage therapyCC armJazz PharmaceuticalsSpeakers bureauEligible patientsFebrile neutropeniaBM blastsConventional careCC patientsPatient populationGrade 3 febrile neutropeniaGrade 3 infusion reactionsPre-treated patient populationAllogeneic hematopoietic cell transplantationAdvisory CommitteeSeattle GeneticsAdequate organ functionDurable complete remissionPre-treated patientsPhase 3 trialProportion of patientsReduced intensity conditioningLack of efficacyThe impact of a multimodal approach to vancomycin discontinuation in hematopoietic stem cell transplant recipients (HSCT) with febrile neutropenia (FN)
Perreault S, McManus D, Bar N, Foss F, Gowda L, Isufi I, Seropian S, Malinis M, Topal JE. The impact of a multimodal approach to vancomycin discontinuation in hematopoietic stem cell transplant recipients (HSCT) with febrile neutropenia (FN). Transplant Infectious Disease 2019, 21: e13059. PMID: 30737868, DOI: 10.1111/tid.13059.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnti-Bacterial AgentsAntimicrobial StewardshipFebrile NeutropeniaFemaleHematopoietic Stem Cell TransplantationHumansMaleMedication Therapy ManagementMethicillin-Resistant Staphylococcus aureusMiddle AgedNoseRetrospective StudiesStaphylococcal InfectionsTime FactorsVancomycinYoung AdultConceptsHematopoietic stem cell transplant recipientsPost-intervention cohortFebrile neutropeniaVancomycin useVancomycin discontinuationStewardship teamRetrospective analysisMultimodal approachStem cell transplant recipientsResistant Gram-positive organismsResistant Gram-positive infectionsAntibiotic stewardship teamDiscontinuation of vancomycinEvidence of pneumoniaPost-implementation cohortPrevious MRSA infectionCell transplant recipientsGram-positive infectionsNasal swab collectionEmpiric vancomycinFN patientsVancomycin ordersVancomycin usageHSCT recipientsTransplant recipients
1999
Neutropenic infections in 100 patients with non-Hodgkin’s lymphoma or Hodgkin’s disease treated with high-dose BEAM chemotherapy and peripheral blood progenitor cell transplant: out-patient treatment is a viable option
Seropian S, Nadkarni R, Jillella A, Salloum E, Burtness B, Hu G, Zelterman D, Cooper D. Neutropenic infections in 100 patients with non-Hodgkin’s lymphoma or Hodgkin’s disease treated with high-dose BEAM chemotherapy and peripheral blood progenitor cell transplant: out-patient treatment is a viable option. Bone Marrow Transplantation 1999, 23: 599-605. PMID: 10217191, DOI: 10.1038/sj.bmt.1701610.Peer-Reviewed Original ResearchMeSH KeywordsAdultAmbulatory CareAntibiotic ProphylaxisAntineoplastic Combined Chemotherapy ProtocolsCarmustineCytarabineDose-Response Relationship, DrugHematopoietic Stem Cell TransplantationHodgkin DiseaseHumansLymphoma, Non-HodgkinMelphalanMiddle AgedNeutropeniaPodophyllotoxinRetrospective StudiesConceptsPeripheral blood progenitor cell transplantHigh-dose chemotherapyAbsolute neutrophil countProgenitor cell transplantCell transplantHodgkin's diseaseHodgkin's lymphomaHerpes simplex virus serologyHigh-dose BEAM chemotherapyGram-positive bacteremiaDuration of neutropeniaRisk of bacteremiaPeriod of neutropeniaMultivariate logistic regressionInvasive fungal infectionsRisk of developmentNumber of CD34Amphotericin therapyBEAM chemotherapyFebrile neutropeniaNeutropenic infectionOral ciprofloxacinWBC engraftmentProphylactic antibioticsCare visits