2021
Mitigating the risk of COVID-19 exposure by transitioning from clinic-based to home-based immune globulin infusion
Perreault S, Schiffer M, Clinchy-Jarmoszko V, Bocchetta N, Barbarotta L, Abdelghany O, Foss F, Huntington S, Seropian S, Isufi I. Mitigating the risk of COVID-19 exposure by transitioning from clinic-based to home-based immune globulin infusion. American Journal Of Health-System Pharmacy 2021, 78: 1112-1117. PMID: 33617630, PMCID: PMC7929449, DOI: 10.1093/ajhp/zxab072.Peer-Reviewed Original ResearchConceptsHome-based infusionsCOVID-19 exposureSCIG infusionsIntravenous immune globulin therapyBetter patient understandingImmune globulin infusionImmune globulin therapyPatient Outcome QuestionnairePatient outcome assessmentInfusion-related complicationsChair timeRisk of infectionCoronavirus disease 2019 (COVID-19) virusGlobulin therapyIVIG infusionIVIG therapyChart reviewImmunosuppressed populationImmunosuppressed patientsInfusion visitsMedical visitsOutcomes QuestionnairePatient satisfactionPatient understandingInfusion clinic
2019
Incidence and outcomes of rare T cell lymphomas from the T Cell Project: hepatosplenic, enteropathy associated and peripheral gamma delta T cell lymphomas
Foss FM, Horwitz SM, Civallero M, Bellei M, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko Y, Montoto S, Chiattone C, Moskowitz A, Spina M, Cesaretti M, Biasoli I, Federico M. Incidence and outcomes of rare T cell lymphomas from the T Cell Project: hepatosplenic, enteropathy associated and peripheral gamma delta T cell lymphomas. American Journal Of Hematology 2019, 95: 151-155. PMID: 31709579, PMCID: PMC8025136, DOI: 10.1002/ajh.25674.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overDisease-Free SurvivalEnteropathy-Associated T-Cell LymphomaFemaleHematopoietic Stem Cell TransplantationHumansIncidenceLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm ProteinsReceptors, Antigen, T-Cell, gamma-deltaSurvival RateTransplantation, AutologousConceptsHepatosplenic T-cell lymphomaT-cell lymphomaEnteropathy-Associated T-Cell LymphomaGamma-delta T-cell lymphomaT-cell ProjectStem cell transplantationCell lymphomaRare subtypeFirst remissionTreatment patternsCell transplantationAutologous stem cell transplantationAllogeneic stem cell transplantationFirst-line therapyLarge prospective trialsProgression-free survivalCells projectRare T cellsNovel treatment approachesFree survivalLine therapyOverall survivalProspective trialAnthracycline regimensClinical trialsPembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study.
Khodadoust MS, Rook AH, Porcu P, Foss F, Moskowitz AJ, Shustov A, Shanbhag S, Sokol L, Fling SP, Ramchurren N, Pierce R, Davis A, Shine R, Li S, Fong S, Kim J, Yang Y, Blumenschein WM, Yearley JH, Das B, Patidar R, Datta V, Cantu E, McCutcheon JN, Karlovich C, Williams PM, Subrahmanyam PB, Maecker HT, Horwitz SM, Sharon E, Kohrt HE, Cheever MA, Kim YH. Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study. Journal Of Clinical Oncology 2019, 38: 20-28. PMID: 31532724, PMCID: PMC6943974, DOI: 10.1200/jco.19.01056.Peer-Reviewed Original ResearchConceptsRefractory mycosis fungoidesSézary syndromeOverall response rateMycosis fungoidesTreatment discontinuationFlare reactionAdvanced MF/SSResponse rateMF/Sézary syndromeMulticenter phase II studyMulticenter phase II trialSeverity-Weighted Assessment ToolHigh PD-1 expressionAdvanced mycosis fungoidesEfficacy of pembrolizumabPrior systemic therapySubsequent clinical responseAdvanced-stage diseasePhase II studyPrimary end pointPD-1 expressionPhase II trialFavorable safety profileTotal mutation burdenLack of responseEffect of leucovorin administration on mucositis and skin reactions in patients with peripheral T-cell lymphoma or cutaneous T-cell lymphoma treated with pralatrexate*
Foss FM, Parker TL, Girardi M, Li A. Effect of leucovorin administration on mucositis and skin reactions in patients with peripheral T-cell lymphoma or cutaneous T-cell lymphoma treated with pralatrexate*. Leukemia & Lymphoma 2019, 60: 2927-2930. PMID: 31119966, DOI: 10.1080/10428194.2019.1612061.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaCutaneous T-cell lymphomaT-cell lymphomaIncidence of mucositisAddition of leucovorinSkin reactionsLeucovorin administrationMucositis incidenceMucositis occurrenceDisease stabilizationAdverse eventsClinical responseCTCL patientsPoor prognosisLeucovorinMucositisPatientsResponse rateLymphomaPralatrexateIncidenceEfficacyPrognosisDosingAdministrationRandomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
O’Connor O, Özcan M, Jacobsen ED, Roncero JM, Trotman J, Demeter J, Masszi T, Pereira J, Ramchandren R, Beaven A, Caballero D, Horwitz SM, Lennard A, Turgut M, Hamerschlak N, d’Amore F, Foss F, Kim WS, Leonard JP, Zinzani PL, Chiattone CS, Hsi ED, Trümper L, Liu H, Sheldon-Waniga E, Ullmann CD, Venkatakrishnan K, Leonard EJ, Shustov AR, . Randomized Phase III Study of Alisertib or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma. Journal Of Clinical Oncology 2019, 37: 613-623. PMID: 30707661, PMCID: PMC6494247, DOI: 10.1200/jco.18.00899.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsAurora Kinase AAzepinesDisease ProgressionDisease-Free SurvivalDrug Resistance, NeoplasmEarly Termination of Clinical TrialsFemaleHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedProtein Kinase InhibitorsPyrimidinesRecurrenceTime FactorsYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaProgression-free survivalOverall response rateT-cell lymphomaComparator armInvestigational Aurora A kinase inhibitorResponse rateMedian progression-free survivalTwo-year overall survivalRandomized phase III studyRandomized phase III trialIndependent data monitoring committeeEfficacy of alisertibMore prior therapiesSingle-agent comparatorCommon adverse eventsPhase III studyPhase III trialsIndependent central reviewData monitoring committeeDrug discontinuationIntravenous romidepsinOral alisertibPrior therapyThe role of autologous stem cell transplantation in patients with nodal peripheral T‐cell lymphomas in first complete remission: Report from COMPLETE, a prospective, multicenter cohort study
Park SI, Horwitz SM, Foss FM, Pinter‐Brown L, Carson KR, Rosen ST, Pro B, Hsi ED, Federico M, Gisselbrecht C, Schwartz M, Bellm LA, Acosta M, Advani RH, Feldman T, Lechowicz MJ, Smith SM, Lansigan F, Tulpule A, Craig MD, Greer JP, Kahl BS, Leach JW, Morganstein N, Casulo C, Shustov AR, Investigators F. The role of autologous stem cell transplantation in patients with nodal peripheral T‐cell lymphomas in first complete remission: Report from COMPLETE, a prospective, multicenter cohort study. Cancer 2019, 125: 1507-1517. PMID: 30694529, PMCID: PMC8269282, DOI: 10.1002/cncr.31861.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCohort StudiesFemaleHematopoietic Stem Cell TransplantationHumansImmunoblastic LymphadenopathyLymphatic MetastasisLymphoma, T-Cell, PeripheralMaleMiddle AgedRemission InductionRetrospective StudiesTransplantation, AutologousYoung AdultConceptsAutologous stem cell transplantationPeripheral T-cell lymphomaNodal peripheral T-cell lymphomaAngioimmunoblastic T-cell lymphomaT-cell lymphomaConsolidative autologous stem cell transplantationFirst complete remissionStem cell transplantationComplete remissionCohort studyCell transplantationImpact of ASCTAggressive peripheral T-cell lymphomaFirst large prospective cohort studyHigh International Prognostic Index scoreUntreated peripheral T-cell lymphomaAnaplastic lymphoma kinase-negative anaplastic large cell lymphomaInternational Prognostic Index scoreLarge prospective cohort studyAnaplastic large cell lymphomaComprehensive Oncology MeasuresMedian overall survivalMulticenter cohort studyAdvanced stage diseaseProgression-free survival
2018
Cutaneous T-Cell Lymphoma: Trends in Radiation Doses and Patterns of Care 2004-2015
Miccio JA, Wilson LD, Kann BH, Jairam V, Beckta J, Foss FM, Yeboa DN. Cutaneous T-Cell Lymphoma: Trends in Radiation Doses and Patterns of Care 2004-2015. Anticancer Research 2018, 39: 253-259. PMID: 30591466, DOI: 10.21873/anticanres.13105.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaLow-dose radiotherapyNational Cancer DatabaseMinority of patientsT-cell lymphomaSimilar response ratesHigh-volume facilitiesLogistic regression modelsAdult patientsMost patientsDose administeredCancer DatabaseEffective treatmentResponse rateRadiotherapyHigh dosesPatientsDosesLess toxicityAnnual percentageRadiation dosesRegression modelsAdministeredLymphomaDiseasePeripheral T cell lymphoma, not otherwise specified (PTCL‐NOS). A new prognostic model developed by the International T cell Project Network
Federico M, Bellei M, Marcheselli L, Schwartz M, Manni M, Tarantino V, Pileri S, Ko Y, Cabrera ME, Horwitz S, Kim WS, Shustov A, Foss FM, Nagler A, Carson K, Pinter‐Brown L, Montoto S, Spina M, Feldman TA, Lechowicz MJ, Smith SM, Lansigan F, Gabus R, Vose JM, Advani RH, Network T. Peripheral T cell lymphoma, not otherwise specified (PTCL‐NOS). A new prognostic model developed by the International T cell Project Network. British Journal Of Haematology 2018, 181: 760-769. PMID: 29672827, PMCID: PMC6033106, DOI: 10.1111/bjh.15258.Peer-Reviewed Original ResearchConceptsT-cell ProjectPeripheral T-cell lymphomaT cell scoreProgression-free survivalT-cell lymphomaOverall survivalCell lymphomaCells projectCox proportional hazards regression analysisMultiple Cox proportional hazards regression analysisProportional hazards regression analysisMedian overall survivalHazards regression analysisNew prognostic modelIntermediate riskPTCL-NOSPrognostic valueUnfavourable outcomeClinical variablesRetrospective analysisHigh riskLower riskPrognostic modelGood discriminant powerNew scoreThe outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project
Bellei M, Foss FM, Shustov AR, Horwitz SM, Marcheselli L, Kim WS, Cabrera ME, Dlouhy I, Nagler A, Advani RH, Pesce EA, Ko YH, Martinez V, Montoto S, Chiattone C, Moskowitz A, Spina M, Biasoli I, Manni M, Federico M. The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica 2018, 103: 1191-1197. PMID: 29599200, PMCID: PMC6029527, DOI: 10.3324/haematol.2017.186577.Peer-Reviewed Original ResearchConceptsBone marrow transplantationInternational T-cell ProjectPeripheral T-cell lymphoma patientsT-cell lymphoma patientsT-cell ProjectOverall survivalMarrow transplantationLymphoma patientsRelapsed Peripheral T-Cell LymphomaPeripheral T-cell lymphomaUnivariate Cox regression analysisChemotherapy-sensitive diseaseMedian overall survivalFirst-line therapyFirst-line treatmentOverall survival rateSurvival of patientsCox regression analysisEnd of treatmentStandard of careT-cell lymphomaMedian followPrimary refractoryBetter OSRefractory/A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma
Foss FM, Parker T. A Phase I Dose‐Escalation Study of Clofarabine in Patients with Relapsed or Refractory Low‐Grade or Intermediate‐Grade B‐Cell or T‐Cell Lymphoma. The Oncologist 2018, 23: 397-e30. PMID: 29438091, PMCID: PMC5896711, DOI: 10.1634/theoncologist.2017-0658.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaNon-Hodgkin lymphomaOverall response rateIntermediate-grade B-cellB cellsPartial responseResponse ratePhase I dose-escalation studyRefractory acute lymphoblastic leukemiaI dose-escalation studyT-cell non-Hodgkin lymphomaB-cell non-Hodgkin lymphomaPositron emission tomography scanSecond-generation purine nucleoside analogAggressive B-cell lymphomasPhase IDose of clofarabineGrade 3 leukopeniaLow-dose cohortMinimal hematologic toxicityRefractory acute leukemiaRefractory low gradeRefractory lymphoid malignanciesSingle-agent rituximab
2017
Activity of the PI3K-δ,γ inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma
Horwitz SM, Koch R, Porcu P, Oki Y, Moskowitz A, Perez M, Myskowski P, Officer A, Jaffe JD, Morrow SN, Allen K, Douglas M, Stern H, Sweeney J, Kelly P, Kelly V, Aster JC, Weaver D, Foss FM, Weinstock DM. Activity of the PI3K-δ,γ inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma. Blood 2017, 131: 888-898. PMID: 29233821, PMCID: PMC5824337, DOI: 10.1182/blood-2017-08-802470.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAged, 80 and overClass I Phosphatidylinositol 3-KinasesClass Ib Phosphatidylinositol 3-KinaseFemaleHumansIsoquinolinesLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMaximum Tolerated DoseMiddle AgedPhosphoinositide-3 Kinase InhibitorsPrognosisPurinesSafetySkin NeoplasmsTissue DistributionConceptsT-cell lymphomaPhospho-AktImmunosuppressive M2-like phenotypeCutaneous T-cell lymphomaNonmalignant immune cellsOpen-label studySerum cytokine profilesAcceptable safety profileImmune-mediated effectsPhase 1 trialOverall response rateM1-like phenotypePatient-derived xenograftsTumor-associated macrophagesM2-like phenotypeInflammatory M1-like phenotypeT cell growthRefractory PTCLTransaminase increaseAdverse eventsClinical responseCytokine profileMaculopapular rashComplete responsePreclinical evidenceDuvelisib, a novel oral dual inhibitor of PI3K-δ,γ, is clinically active in advanced hematologic malignancies
Flinn IW, O'Brien S, Kahl B, Patel M, Oki Y, Foss FF, Porcu P, Jones J, Burger JA, Jain N, Kelly VM, Allen K, Douglas M, Sweeney J, Kelly P, Horwitz S. Duvelisib, a novel oral dual inhibitor of PI3K-δ,γ, is clinically active in advanced hematologic malignancies. Blood 2017, 131: 877-887. PMID: 29191916, PMCID: PMC6033052, DOI: 10.1182/blood-2017-05-786566.Peer-Reviewed Original ResearchConceptsT-cell lymphomaChronic lymphocytic leukemiaIndolent non-Hodgkin lymphomaOral dual inhibitorAdvanced hematologic malignanciesComplete responseTransaminase increaseHematologic malignanciesRefractory chronic lymphocytic leukemiaPeripheral T-cell lymphomaCutaneous T-cell lymphomaAlanine transaminase increaseHematologic malignancy treatmentDose-escalation phaseSevere adverse eventsPhase 1 studyDual inhibitorOverall response rateLate-stage clinical developmentNon-Hodgkin lymphomaCLL tumor cellsRange of dosesAdverse eventsClinical responseMedian timeAnnual Facility Treatment Volume and Patient Survival for Mycosis Fungoides and Sézary Syndrome
Kann BH, Park HS, Yeboa DN, Aneja S, Girardi M, Foss FM, Roberts KB, Wilson LD. Annual Facility Treatment Volume and Patient Survival for Mycosis Fungoides and Sézary Syndrome. Clinical Lymphoma Myeloma & Leukemia 2017, 17: 520-526.e2. PMID: 28655598, DOI: 10.1016/j.clml.2017.05.017.Peer-Reviewed Original ResearchConceptsMF/SSOverall survivalSézary syndromeHazard ratioImproved survivalMycosis fungoidesPatient survivalHighest quintileLowest quintileTreatment volumeImproved overall survivalMultivariable Cox regressionNational Cancer DatabaseKaplan-Meier methodAnnual patient volumeNational database analysisLog-rank testContinuous variablesMedian followMultivariable analysisCox regressionOS survivalCancer DatabasePatientsPatient volumeAnalysis of Peripheral T-cell Lymphoma Diagnostic Workup in the United States
Hsi ED, Horwitz SM, Carson KR, Pinter-Brown LC, Rosen ST, Pro B, Federico M, Gisselbrecht C, Schwartz M, Bellm LA, Acosta M, Collie AM, Gruver AM, Grzywacz BJ, Turakhia S, Shustov AR, Advani RH, Feldman T, Lechowicz MJ, Smith SM, Lansigan F, Tulpule A, Craig MD, Greer JP, Kahl BS, Leach JW, Morganstein N, Casulo C, Park SI, Foss FM. Analysis of Peripheral T-cell Lymphoma Diagnostic Workup in the United States. Clinical Lymphoma Myeloma & Leukemia 2017, 17: 193-200. PMID: 28209473, DOI: 10.1016/j.clml.2016.10.001.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaAngioimmunoblastic T-cell lymphomaAnaplastic large cell lymphomaPTCL-NOS casesT-cell lymphomaLarge cell lymphomaDiagnostic workupCell lymphomaCases of AITLLarge prospective cohort studyComprehensive Oncology MeasuresProspective cohort studyCommunity-based centersSubtype-specific approachesWorld Health OrganizationAccuracy of diagnosisCohort studyCommon diagnosisHistopathologic diagnosisSensitive markerAcademic centersPatientsLymphomaLymphoma studyPrecise diagnosis
2016
Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma
Foss F, Pro B, Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T‐cell lymphoma. Cancer Medicine 2016, 6: 36-44. PMID: 27981793, PMCID: PMC5269566, DOI: 10.1002/cam4.939.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaLines of therapyLong-term outcomesT-cell lymphomaPrior therapyAdverse eventsTreatment of PTCLPivotal phase 2 trialAggressive non-Hodgkin lymphomaLast prior therapyObjective response rateFirst-line treatmentPhase 2 trialUnconfirmed complete responseLine of treatmentNon-Hodgkin lymphomaUse of romidepsinDisease refractorySalvage treatmentDose modificationMedian durationMost patientsPrior linesComplete responseClinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides
Foss F, Duvic M, Lerner A, Waksman J, Whittaker S. Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides. Clinical Lymphoma Myeloma & Leukemia 2016, 16: 637-643. PMID: 27637428, DOI: 10.1016/j.clml.2016.08.009.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaFolliculotropic mycosis fungoidesPrevious systemic therapyMycosis fungoidesDisease involvementCutaneous tumorsTumor stageSystemic therapyRefractory cutaneous T-cell lymphomaSubtypes of CTCLSafety of romidepsinObjective response ratePhase II studyAggressive disease courseReview of diagnosisT-cell lymphomaHistone deacetylase inhibitorsII studyComposite endpointDisease courseHistology reportsClinical efficacyUncommon subtypeFavorable outcomePatientsRomidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. Journal Of Hematology & Oncology 2016, 9: 22. PMID: 26965915, PMCID: PMC4785666, DOI: 10.1186/s13045-016-0243-8.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDisease ProgressionDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFatigueFemaleHistone Deacetylase InhibitorsHumansLymphoma, T-Cell, PeripheralMaleMiddle AgedNauseaNeoplasm Recurrence, LocalNeutropeniaRemission InductionTime FactorsTreatment OutcomeYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaStable diseaseT-cell lymphomaClinical benefitPivotal trialsCell lymphomaDay 1Good responseLong stable diseaseObjective response rateProgression-free survivalUnconfirmed complete responseT-cell malignanciesHistone deacetylase inhibitorsProlonged dosingDurable responsesMedian durationObjective responsePartial responseComplete responseCurrent therapiesProtocol amendmentCell malignanciesPatients
2015
A phase II study of cyclophosphamide, etoposide, vincristine and prednisone (CEOP) Alternating with Pralatrexate (P) as front line therapy for patients with peripheral T‐cell lymphoma (PTCL): final results from the T‐ cell consortium trial
Advani RH, Ansell SM, Lechowicz MJ, Beaven AW, Loberiza F, Carson KR, Evens AM, Foss F, Horwitz S, Pro B, Pinter-Brown LC, Smith SM, Shustov AR, Savage KJ, Vose J. A phase II study of cyclophosphamide, etoposide, vincristine and prednisone (CEOP) Alternating with Pralatrexate (P) as front line therapy for patients with peripheral T‐cell lymphoma (PTCL): final results from the T‐ cell consortium trial. British Journal Of Haematology 2015, 172: 535-544. PMID: 26627450, PMCID: PMC5642048, DOI: 10.1111/bjh.13855.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaStem cell transplantationT-cell lymphomaFront-line therapyLine therapyCell lymphomaRefractory peripheral T-cell lymphomaConsolidative stem cell transplantationAngioimmunoblastic T-cell lymphomaAnaplastic large cell lymphomaConventional CHOP chemotherapyPhase II studyStage IV diseaseFront-line settingPhase 2 studyProgression-free survivalInternational Prognostic IndexLarge cell lymphomaFebrile neutropeniaPTCL patientsCHOP chemotherapyLiver transaminasesPartial remissionConsortium TrialII studyBelinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study
O'Connor OA, Horwitz S, Masszi T, Van Hoof A, Brown P, Doorduijn J, Hess G, Jurczak W, Knoblauch P, Chawla S, Bhat G, Choi MR, Walewski J, Savage K, Foss F, Allen LF, Shustov A. Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma: Results of the Pivotal Phase II BELIEF (CLN-19) Study. Journal Of Clinical Oncology 2015, 33: 2492-2499. PMID: 26101246, PMCID: PMC5087312, DOI: 10.1200/jco.2014.59.2782.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalSulfonamidesTreatment OutcomeConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaInternational Working Group criteriaOverall response rateT-cell lymphomaPrior therapyOverall survivalGroup criteriaResponse rateEnd pointCommon grade 3Prior systemic therapyPrimary end pointSecondary end pointsNovel histone deacetylase inhibitorStem cell transplantationDuration of responseStandard of careDrug Administration approvalHistone deacetylase inhibitorsEvaluable patientsManageable toxicityAdverse eventsDurable responsesPartial responseResimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma
Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM. Resimmune, an anti-CD3ε recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica 2015, 100: 794-800. PMID: 25795722, PMCID: PMC4450625, DOI: 10.3324/haematol.2015.123711.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaT-cell lymphomaComplete remissionRecombinant immunotoxinCommon adverse eventsDose-escalation trialLow tumor burdenAssessment Tool scoreDurable remissionsEscalation trialPartial remissionAdverse eventsTumor burdenIntravenous infusionPatientsRemissionTool scoreResponse rateSingle-chain antibody fragmentChain antibody fragmentsLymphomaDiphtheria toxinFurther studiesImmunotoxinTrials