2021
Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study
Jacobs R, Jurczak W, Flinn I, Grosicki S, Giannopoulos K, Wróbel T, Zafar S, Cultrera J, Kambhampati S, Danilov A, Burke J, Goldschmidt J, Beach D, Huntington S, Ibarz J, Sharman J, Siddiqi T, Brander D, Shadman M, Pagel J, Dlugosz-Danecka M, Ghosh N, Kolibaba K, Sportelli P, Miskin H, O'Connor O, Weiss M, Gribben J. Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study. Blood 2021, 138: 3726. DOI: 10.1182/blood-2021-147460.Peer-Reviewed Original ResearchSarah Cannon Research InstituteProgression-free survivalOverall response rateChronic lymphocytic leukemiaCurrent equity holderMedian progression-free survivalUndetectable minimal residual diseaseNon-infectious colitisBristol-Myers SquibbTreatment-naïveTN patientsTreatment statusAstra ZenecaSpeakers bureauKite PharmaPFS ratesMedian durationStudy drugMedian agePT patientsADC therapeuticsDay 1Primary analysisEnhanced antibody-dependent cellular cytotoxicityAntibody-dependent cellular cytotoxicityA Global Phase 2 Study of Valemetostat Tosylate (Valemetostat) in Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL), Including R/R Adult T-Cell Leukemia/Lymphoma (ATL) - Valentine-PTCL01
Foss F, Porcu P, Horwitz S, Izutsu K, Ishitsuka K, Kato K, Jin J, Du Y, Inoue A. A Global Phase 2 Study of Valemetostat Tosylate (Valemetostat) in Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL), Including R/R Adult T-Cell Leukemia/Lymphoma (ATL) - Valentine-PTCL01. Blood 2021, 138: 2533. DOI: 10.1182/blood-2021-144676.Peer-Reviewed Original ResearchR Peripheral T Cell LymphomaTreatment-emergent adverse eventsPeripheral T-cell lymphomaALK-positive anaplastic large cell lymphomaT-cell lymphomaNon-Hodgkin lymphomaPhase 2 studyOverall response rateKyowa Hakko KirinPersonal feesCohort 1Current equity holderDaiichi SankyoResponse rateSeattle GeneticsOno PharmaceuticalCohort 2Computed tomographyMonomorphic epitheliotropic intestinal T-cell lymphomaActive central nervous system (CNS) involvementADC therapeuticsSerious treatment-emergent adverse eventsRefractory peripheral T-cell lymphomaNodal peripheral T-cell lymphomaAllogeneic hematopoietic cell transplantHigh-Grade B-Cell Lymphoma, Not Otherwise Specified (HGBL, NOS): Characteristics, Treatment, and Outcomes from 17 Academic US Centers
Zayac A, Landsburg D, Hughes M, Ayers E, Girton M, Hu M, Beckman A, Li S, Medeiros L, Kurt H, Sandoval-Sus J, Ansari-Lari M, Kothari S, Kress A, Xu M, Torka P, Sundaram S, Smith S, Naresh K, Karimi Y, Epperla N, Bond D, Evens A, Pandya K, Naik S, Kamdar M, Haverkos B, Karmali R, Oh T, Vose J, Nutsch H, Rubinstein P, Chaudhry A, Olszewski A. High-Grade B-Cell Lymphoma, Not Otherwise Specified (HGBL, NOS): Characteristics, Treatment, and Outcomes from 17 Academic US Centers. Blood 2021, 138: 455. DOI: 10.1182/blood-2021-144308.Peer-Reviewed Original ResearchInternational Prognostic IndexDA-EPOCHOverall survivalComplete responseB-cell lymphomaWorld Health OrganizationSpeakers bureauADC therapeuticsLactate dehydrogenaseCommon first-line regimensHigh serum lactate dehydrogenaseAdvisory board membersChimeric antigen receptor T cellsCentral nervous system involvementAntigen receptor T cellsGrade B-cell lymphomaAdvisory CommitteeAggressive B-cell lymphomasMYC extra copiesPoor performance statusOutcomes of patientsDe novo tumorsFirst-line regimensNervous system involvementGerminal center B-cell phenotypeImpact of Molecular Features of Diffuse Large B-Cell Lymphoma on Treatment Outcomes with Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy
Hill B, Roth C, Kositsky R, Dave T, Love C, McKinney M, Galal A, Neff J, Mian A, Kendall E, Ondrejka S, Chiaramonte M, Bhagat G, Ofori K, Reshef R, Kovach A, Sethi T, Mason E, Bhaskar S, Oluwole O, Pallas C, Ghosh N, Ferdman R, Chen G, Hernandez-Ilizaliturri F, Zurko J, Cunningham A, Shah N, Hu B, Stephens D, Ghosh M, Bailey N, Patel K, Pagel J, Kannan K, Hsi E, Vaidya R, Ip A, Goy A, Kambhampati S, Ohgami R, Andreadis C, Thacker E, Rozzi C, Parker C, Happ L, Dave S. Impact of Molecular Features of Diffuse Large B-Cell Lymphoma on Treatment Outcomes with Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy. Blood 2021, 138: 165. DOI: 10.1182/blood-2021-145764.Peer-Reviewed Original ResearchCAR T-cell therapyDiffuse large B-cell lymphomaChimeric antigen receptor T-cell therapyLarge B-cell lymphomaT-cell therapyCAR-T therapyB-cell lymphomaInferior PFSR diseaseBristol-Meyers SquibbCurrent equity holderADC therapeuticsCell therapySpeakers bureauBristol-Myers SquibbKite PharmaDLBCL patientsTreatment outcomesAnti-CD19 chimeric antigen receptor (CAR) T-cell therapyCD19 chimeric antigen receptor (CAR) T-cell therapyIntroduction Diffuse large B-cell lymphomaPre-treatment tumor biopsiesRelapsed/refractory (R/R) diseaseCAR T-cell infusionAdvisory Committee
2020
Worldwide Examination of Patients with CLL Hospitalized for COVID-19
Roeker L, Scarfo L, Chatzikonstantinou T, Abrisqueta P, Eyre T, Cordoba R, Prat A, Villacampa G, Leslie L, Koropsak M, Quaresmini G, Allan J, Furman R, Bhavsar E, Pagel J, Hernandez-Rivas J, Patel K, Motta M, Bailey N, Miras F, Lamanna N, Alonso R, Osorio-Prendes S, Vitale C, Kamdar M, Baltasar P, Österborg A, Hanson L, Baile M, Rodríguez-Hernández I, Valenciano S, Popov V, Garcia A, Alfayate A, Oliveira A, Eichhorst B, Quaglia F, Reda G, Jimenez J, Varettoni M, Marchetti M, Romero P, Grau R, Munir T, Zabalza A, Janssens A, Niemann C, Perini G, Delgado J, San Segundo L, Roncero M, Wilson M, Patten P, Marasca R, Iyengar S, Seddon A, Torres A, Ferrari A, Cuéllar-García C, Wojenski D, El-Sharkawi D, Itchaki G, Parry H, Mateos-Mazón J, Martinez-Calle N, Ma S, Naya D, Van Der Spek E, Seymour E, Vázquez E, Rigolin G, Mauro F, Walter H, Labrador J, De Paoli L, Laurenti L, Ruiz E, Levin M, Šimkovič M, Špaček M, Andreu R, Walewska R, Perez-Gonzalez S, Sundaram S, Wiestner A, Cuesta A, Broom A, Kater A, Muiña B, Velasquez C, Ujjani C, Seri C, Antic D, Bron D, Vandenberghe E, Chong E, Lista E, García F, Del Poeta G, Ahn I, Pu J, Brown J, Campos J, Malerba L, Trentin L, Orsucci L, Farina L, Villalon L, Vidal M, Sanchez M, Terol M, De Paolis M, Gentile M, Davids M, Shadman M, Yassin M, Foglietta M, Jaksic O, Sportoletti P, Barr P, Ramos R, Santiago R, Ruchlemer R, Kersting S, Huntington S, Herold T, Herishanu Y, Thompson M, Lebowitz S, Ryan C, Jacobs R, Portell C, Isaac K, Rambaldi A, Nabhan C, Brander D, Montserrat E, Rossi G, Garcia-Marco J, Coscia M, Malakhov N, Fernandez-Escalada N, Skånland S, Coombs C, Ghione P, Schuster S, Foà R, Cuneo A, Bosch F, Stamatopoulos K, Ghia P, Mato A, Patel M. Worldwide Examination of Patients with CLL Hospitalized for COVID-19. Blood 2020, 136: 45-49. PMCID: PMC8330255, DOI: 10.1182/blood-2020-136408.Peer-Reviewed Original ResearchCase fatality rateInferior overall survivalOverall survivalCOVID-19 diagnosisAstra ZenecaMultivariable analysisSpeaker feesSeattle GeneticsSpeakers bureauAbbVie IncSanofi GenzymeBaseline characteristicsIndependent predictorsF. Hoffmann-La RocheJanssen-CilagCOVID-19ADC therapeuticsStandardized case report formAdvisory CommitteeEducational meetingsHoffmann-La RocheF. Hoffmann-La Roche LtdAdvanced patient ageSevere COVID-19Kaplan-Meier methodVenetoclax Therapy for Relapsed and Treatment Refractory AML: Clinical Outcomes and Molecular Predictors
Stahl M, Menghrajani K, Derkach A, Chan A, Xiao W, Glass J, King A, Daniyan A, Famulare C, Cuello B, Abdel-Wahab O, Levine R, Viny A, Stein E, Roshal M, Tallman M, Goldberg A. Venetoclax Therapy for Relapsed and Treatment Refractory AML: Clinical Outcomes and Molecular Predictors. Blood 2020, 136: 47-48. DOI: 10.1182/blood-2020-137815.Peer-Reviewed Original ResearchCurrent equity holderEntity's Board of DirectorsRR-AMLRR-AML patientsMeasurable residual diseaseOverall survivalCombination therapyVenetoclax therapyAdverse cytogeneticsComplete responseResponse rateMedian OSRefractory AMLResidual diseaseEuropean LeukemiaNetMolecular predictorsClinical outcomesADC therapeuticsAssociated with prolonged OSCycle 1 day 1Venetoclax-based combination therapiesAllogeneic stem cell transplantationLevel of residual diseaseAssociated with poor OSMemorial Sloan Kettering Cancer CenterCNS Prophylaxis during Front-Line Therapy in Aggressive Non-Hodgkin Lymphomas: Real-World Outcomes and Practice Patterns from 19 US Academic Institutions
Orellana-Noia V, Reed D, Sen J, Barlow C, Malecek M, Kahl B, Spinner M, Advani R, Voorhees T, Snow A, Grover N, Ayers A, Romancik J, Liu Y, Huntington S, Chavez J, Saeed H, Lazaryan A, Raghunathan V, Spurgeon S, Ollila T, Del Prete C, Olszewski A, Ayers E, Landsburg D, Echalier B, Lee J, Kamdar M, Caimi P, Fu T, Liu J, David K, Alharthy H, Law J, Karmali R, Shah H, Stephens D, Major A, Rojek A, Smith S, Yellala A, Kallam A, Nakhoda S, Khan N, Cohen J, Portell C. CNS Prophylaxis during Front-Line Therapy in Aggressive Non-Hodgkin Lymphomas: Real-World Outcomes and Practice Patterns from 19 US Academic Institutions. Blood 2020, 136: 27-28. DOI: 10.1182/blood-2020-134798.Peer-Reviewed Original ResearchAggressive non-Hodgkin lymphomaNon-Hodgkin lymphomaGenentech/RocheDouble-hit lymphomaCNS-IPIAstra ZenecaSeattle GeneticsBristol-Myers SquibbSpeakers bureauElevated LDHRituximab eraHIV statusUS academic institutionsADC therapeuticsB cellsSignificant differencesMedian age 61 yearsIndolent non-Hodgkin lymphomaAdvisory CommitteeHigh-grade B-cellDiffuse large B-cellAnthracycline-based therapyECOG PS 0Recipients of chemotherapyAge 61 yearsFrontline Bendamustine and Rituximab in Extranodal Marginal Zone Lymphoma: An International Analysis
Alderuccio J, Beaven A, Shouse G, Epperla N, Stefanovic A, Torka P, Castillo J, Argnani L, Voorhees T, Alpert A, Chowdhury S, Reis I, Zhao W, Edwards D, Martin P, Kamdar M, Herrera A, Friedberg J, Zinzani P, Lossos I. Frontline Bendamustine and Rituximab in Extranodal Marginal Zone Lymphoma: An International Analysis. Blood 2020, 136: 2-3. DOI: 10.1182/blood-2020-137620.Peer-Reviewed Original ResearchExtranodal marginal zone lymphomaEntity's Board of DirectorsIncidence of infectious complicationsMarginal zone lymphomaNo survival differenceRituximab maintenanceOverall survivalMALT-IPIInfectious complicationsSurvival differencesBone marrowPrognostic factors associated with worse outcomesADC therapeuticsIncidence of herpes zoster infectionECOG performance status 0Cases of acute myeloid leukemiaFactors associated with worse outcomesNon-gastric locationPerformance status 0ECOG performance statusGastric extranodal marginal zone lymphomaExpert pathology reviewHerpes zoster infectionMajority of patientsLog-rank testSafety and Efficacy of Maintenance Treatment Following Allogeneic Hematopoietic Cell Transplant in Acute Myeloid Leukemia and Myelodysplastic Syndrome - a Systematic Review and Meta-Analysis
Bewersdorf J, Tallman M, Cho C, Zeidan A, Stahl M. Safety and Efficacy of Maintenance Treatment Following Allogeneic Hematopoietic Cell Transplant in Acute Myeloid Leukemia and Myelodysplastic Syndrome - a Systematic Review and Meta-Analysis. Blood 2020, 136: 34-35. DOI: 10.1182/blood-2020-136671.Peer-Reviewed Original ResearchAcute myeloid leukemiaRelapse-free survivalAllogeneic hematopoietic cell transplantHematopoietic cell transplantFLT3 inhibitorsMyelodysplastic syndromeAllo-HCTOverall survivalRFS ratesChronic GVHDMaintenance therapyCell transplantPatient selectionClinical trialsMyeloid leukemiaADC therapeuticsSystematic reviewMinimal residual disease testingAdvisory CommitteeDaiichi SankyoHigh-risk geneticsRate of GVHDPre-emptive treatmentCareful patient selectionPrognosis of patients
2019
AG-636 for the Treatment of Adults with Advanced Lymphoma: Initiation of a Phase 1 Clinical Study
Huntington S, Kallam A, Basile F, Ulanet D, Xu H, Yin F, Mobilia M, Cooper M, Shah B, Leonard J, von Keudell G, Gopal A. AG-636 for the Treatment of Adults with Advanced Lymphoma: Initiation of a Phase 1 Clinical Study. Blood 2019, 134: 1286. DOI: 10.1182/blood-2019-123420.Peer-Reviewed Original ResearchDose-limiting toxicityDiffuse large B-cellDose-escalation phaseAgios PharmaceuticalsAdvanced lymphomaHematologic malignanciesKaryopharm TherapeuticsSeattle GeneticsEscalation phaseT cellsEastern Cooperative Oncology Group performance statusADC therapeuticsActive central nervous system diseaseAdaptive Bayesian logistic regression modelChimeric antigen receptor T-cell therapyPrior stem cell transplantSerum total bilirubin levelPhase 1 clinical studyCentral nervous system diseaseDose-expansion phaseOptimal starting doseCycles of therapyOpen-label studyAbsolute neutrophil countAdvanced solid tumorsDynamic Assembly of a Feedback Complex to Regulate Oncogenic B-Cell Receptor-Signaling
Lee J, Kume K, Chen Z, Xiao G, Cosgun K, Chen L, Chan L, Klemm L, Chen C, Ma N, Chan W, Forman S, Zammarchi F, Van Berkel P, Melnick A, Ngo V, Geng H, Luger S, Litzow M, McManus M, Vaidehi N, Paietta E, Meffre E, Weinstock D, Müschen M. Dynamic Assembly of a Feedback Complex to Regulate Oncogenic B-Cell Receptor-Signaling. Blood 2019, 134: 393. DOI: 10.1182/blood-2019-131270.Peer-Reviewed Original ResearchB-cell malignanciesB-cell leukemiaB cell receptorPoor clinical outcomeTransplant recipientsB cellsCytoplasmic tailClinical outcomesADC therapeuticsFatal diseaseProximity-dependent biotin identificationRefractory B-cell malignanciesPatient-derived xenograft modelsT cell growth factorNormal B cell developmentClinical outcome dataShort cytoplasmic tailHomology-directed repairB-cell receptor signalingCell membrane translocationNF-κB activationInterleukin-2 (IL-2) functionB cell developmentB-cell tumorsGenetic mouse modelsSafety, Efficacy and Biomarker Analysis of a Phase 1b/2 Study of Onvansertib (ONV), a Polo-like Kinase 1 (PLK1) Inhibitor, in Combination with Low-Dose Cytarabine (LDAC) or Decitabine (DEC) in Patients (pts) with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Zeidan A, Schiller G, Lin T, Becker P, Patel P, Wang E, Spira A, Tsai M, Ridinger M, Croucher P, Erlander M, Silberman S. Safety, Efficacy and Biomarker Analysis of a Phase 1b/2 Study of Onvansertib (ONV), a Polo-like Kinase 1 (PLK1) Inhibitor, in Combination with Low-Dose Cytarabine (LDAC) or Decitabine (DEC) in Patients (pts) with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). Blood 2019, 134: 230. DOI: 10.1182/blood-2019-126262.Peer-Reviewed Original ResearchPositive ptsBiomarker positivityPhase 1bBristol-Myers SquibbSpeakers bureauObjective responseCount recoveryPreliminary efficacyBlood samplesNegative groupRelapsed/Refractory Acute Myeloid LeukemiaADC therapeuticsDay 1Jazz PharmaceuticalsRefractory acute myeloid leukemiaBoehringer IngelheimDaiichi SankyoIncomplete count recoveryPhase 1b/2 studyPreclinical AML modelsSubset of ptsLow-dose cytarabinePredictive gene expression signaturesDose-escalation trialPlatelet count recoveryA Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results
Zeidan A, DeAngelo D, Palmer J, Seet C, Tallman M, Wei X, Li Y, Hock N, Burgess M, Hege K, Stock W. A Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results. Blood 2019, 134: 1320. DOI: 10.1182/blood-2019-125363.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsR AMLHigh-risk myelodysplastic syndromeAnti-drug antibodiesAcute myeloid leukemiaMyelodysplastic syndromeADC therapeuticsJazz PharmaceuticalsDaiichi SankyoCelgene CorporationFebrile neutropeniaDose levelsDevelopment of ADAGrade treatment-emergent adverse eventsSerious treatment-emergent adverse eventsGeneral physical health deteriorationPhase I multicenter studyPrior stem cell transplantRefractory acute myeloid leukemiaRed blood cell transfusionBCR-ABL kinase domainAdvisory CommitteeAnti-CD47 monoclonal antibodyExcess blasts-2Grade 4 sepsis
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