2024
Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study
Iyer S, Sica R, Ho P, Prica A, Zain J, Foss F, Hu B, Beitinjaneh A, Weng W, Kim Y, Khodadoust M, Huen A, Williams L, Ma A, Huang E, Ganpule A, Nagar S, Sripakdeevong P, Cullingford E, Karnik S, Dequeant M, Patel J, He X, Li Z, He Q, Mendonez J, Keegan A, Horwitz S. Safety and activity of CTX130, a CD70-targeted allogeneic CRISPR-Cas9-engineered CAR T-cell therapy, in patients with relapsed or refractory T-cell malignancies (COBALT-LYM): a single-arm, open-label, phase 1, dose-escalation study. The Lancet Oncology 2024 PMID: 39617017, DOI: 10.1016/s1470-2045(24)00508-4.Peer-Reviewed Original ResearchT-cell lymphomaPeripheral T-cell lymphomaCutaneous T-cell lymphomaRefractory T-cell lymphomaEastern Cooperative Oncology GroupChimeric antigen receptorCytokine release syndromeCAR+ T cellsSerious adverse eventsAdverse eventsT cellsOpen-labelRefractory peripheral T-cell lymphomaAllogeneic chimeric antigen receptorHealthy donor T cellsRefractory T-cell malignanciesCAR-T cell therapyMedian patient follow-upIncidence of adverse eventsDonor T cellsObjective response rateSystemic therapy linesDose-limiting toxicityT-cell therapyDose-escalation studyTCL-391 Valemetostat Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas: Primary Results From a Phase 1 Trial
Maruyama D, Porcu P, Tobinai K, Allen P, Ishitsuka K, Tsukasaki K, Kusumoto S, Narita T, Foss F, Yamauchi N, Yuda J, Morishima S, Imaizumi Y, Izutsu K, Feldman T, Kawamata T, Kakurai Y, Yamauchi H, Biserna N, Maruyama A, Tachibana M, Hizukuri Y, Horwitz S, Jacobsen E. TCL-391 Valemetostat Monotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphomas: Primary Results From a Phase 1 Trial. Clinical Lymphoma Myeloma & Leukemia 2024, 24: s523-s524. DOI: 10.1016/s2152-2650(24)01617-3.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsB-NHLR/R NHLPartial responseEZH2 mutationsAdverse eventsMedian duration of responseRecommended phase 2 doseRelapsed/refractory non-Hodgkin lymphomaTreatment-related adverse eventsPhase 2 doseR/R follicular lymphomaNon-Hodgkin's lymphomaDuration of responseMaximum tolerated doseDecreased platelet countPhase 1 trialYears of ageFollicular lymphomaTolerated doseDose reductionOpen-labelMedian durationEfficacy analysisMedian agePhase 2 trial of the farnesyltransferase inhibitor tipifarnib for relapsed/refractory peripheral T-cell lymphoma
Witzig T, Sokol L, Kim W, de la Cruz Vicente F, García-Sancho A, Advani R, Vidal J, de Oña Navarrete R, Marin-Niebla A, Izquierdo A, Terol M, Domingo-Domenech E, Saunders A, Bendris N, Mackey J, Leoni M, Foss F. Phase 2 trial of the farnesyltransferase inhibitor tipifarnib for relapsed/refractory peripheral T-cell lymphoma. Blood Advances 2024, 8: 4581-4592. PMID: 38991123, PMCID: PMC11401221, DOI: 10.1182/bloodadvances.2024012806.Peer-Reviewed Original ResearchRelapsed/refractory peripheral T-cell lymphomaAngioimmunoblastic T-cell lymphomaPeripheral T-cell lymphomaT-cell lymphomaProgression-free survivalDuration of responseAdverse eventsAngioimmunoblastic T-cell lymphoma patientsMedian duration of responseMedian progression-free survivalSafety of tipifarnibHematologic adverse eventsMedian overall survivalTreatment-related deathsBiomarkers of responsePhase 2 trialSixty-five patientsFarnesyltransferase inhibitor tipifarnibNon-responder groupTumor mutational profileSingle-arm trialPTCL-NOSOpen-labelOverall survivalPrimary endpoint
2023
Valemetostat for Relapsed or Refractory Peripheral T-Cell Lymphomas: Primary Results from a Phase 1 Trial
Jacobsen E, Maruyama D, Porcu P, Tobinai K, Allen P, Ishitsuka K, Tsukasaki K, Kusumoto S, Foss F, Yamauchi N, Morishima S, Imaizumi Y, Izutsu K, Feldman T, Kawamata T, Kakurai Y, Yamauchi H, Biserna N, Inoue A, Tsutsumi S, Horwitz S. Valemetostat for Relapsed or Refractory Peripheral T-Cell Lymphomas: Primary Results from a Phase 1 Trial. Blood 2023, 142: 303. DOI: 10.1182/blood-2023-172512.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaAdult T-cell leukemia/lymphomaT-cell non-Hodgkin lymphomaObjective response rateDuration of responseProgression-free survivalT-cell lymphomaMedian DORATLL groupPTCL groupData cutoffAdverse eventsClinical activityResponse rateRefractory peripheral T-cell lymphomaMedian progression-free survivalAngioimmunoblastic T-cell lymphomaT-cell leukemia/lymphomaDose-expansion cohortsDose-expansion phaseMedian prior therapiesPreliminary efficacy assessmentComplete response rateDose-escalation phasePhase 2 trial
2021
Adverse cardiovascular events in patients treated with mogamulizumab
Kwan J, Henry M, Cook K, Higgins A, Cuomo J, Foss F, Baldassarre L. Adverse cardiovascular events in patients treated with mogamulizumab. American Heart Journal Plus Cardiology Research And Practice 2021, 9: 100049. PMID: 38559371, PMCID: PMC10978139, DOI: 10.1016/j.ahjo.2021.100049.Peer-Reviewed Original ResearchAdverse cardiovascular eventsMogamulizumab therapyCardiovascular eventsHeart failureAdverse outcomesNon-cardiovascular eventsWorld Health Organization databaseFatal adverse outcomesT-cell leukemiaACE occurrenceMogamulizumab treatmentNew hypertensionAdverse eventsCardiac deathVentricular arrhythmiasFatal outcomeUnique patientsCardiovascular toxicityMyocardial infarctionImportant treatmentHigh mortalityPatientsMogamulizumabTherapyOrganization databaseEfficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial
Cowan R, Scarisbrick J, Zinzani P, Nicolay J, Sokol L, Pinter‐Brown L, Quaglino P, Iversen L, Dummer R, Musiek A, Foss F, Ito T, Rosen J, Medley M. Efficacy and safety of mogamulizumab by patient baseline blood tumour burden: a post hoc analysis of the MAVORIC trial. Journal Of The European Academy Of Dermatology And Venereology 2021, 35: 2225-2238. PMID: 34273208, PMCID: PMC9290719, DOI: 10.1111/jdv.17523.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalBlood tumor burdenSézary syndromeMycosis fungoidesB2 patientsBlood involvementTumor burdenInvestigator-assessed progression-free survivalSuperior objective response rateTreatment-emergent adverse eventsRefractory mycosis fungoidesGreater clinical benefitCD8 ratioAdverse eventsSystemic therapyClinical benefitMogamulizumabPatient responseSustained reductionNext treatmentPatientsResponse rateCell countVorinostatSGNTGT-001: A phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress).
Garralda E, Sanborn R, Minchom A, Davar D, Curigliano G, Ribrag V, Mehta A, Foss F, Zain J, Forero-Torres A, Ansell S. SGNTGT-001: A phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress). Journal Of Clinical Oncology 2021, 39: tps2657-tps2657. DOI: 10.1200/jco.2021.39.15_suppl.tps2657.Peer-Reviewed Original ResearchAnti-tumor immune responseInhibitory immune checkpoint receptorsRegulatory cell depletionObjective response ratePhase II doseProgression-free survivalDose-limiting toxicityMetastatic solid tumorsPhase 1 studyT cell responsesT cell immunoreceptorImmune checkpoint receptorsImmune cell activationPK-PD correlationsAnti-tumor activityExpansion cohortPrimary endpointSecondary endpointsAdvanced malignanciesAdverse eventsLaboratory abnormalitiesMemory CD8Overall survivalComplete responseNK cellsBelinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma
Johnston PB, Cashen AF, Nikolinakos PG, Beaven AW, Barta SK, Bhat G, Hasal SJ, De Vos S, Oki Y, Deng C, Foss FM. Belinostat in combination with standard cyclophosphamide, doxorubicin, vincristine and prednisone as first-line treatment for patients with newly diagnosed peripheral T-cell lymphoma. Experimental Hematology & Oncology 2021, 10: 15. PMID: 33602316, PMCID: PMC7893947, DOI: 10.1186/s40164-021-00203-8.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaOverall response rateT-cell lymphomaAdverse eventsDay 1Untreated peripheral T-cell lymphomaRefractory peripheral T-cell lymphomaMedian relative dose intensityPatient experienced DLTSafety/tolerabilityRelative dose intensityResultsTwenty-three patientsSerious adverse eventsFirst-line treatmentHistone deacetylase inhibitorsExperienced DLTsFebrile neutropeniaStandard CHOPStandard cyclophosphamideDose intensityAdditional patientsMTD doseCHOP combinationPK parametersSame dose
2019
Effect 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 rateLymphomaPralatrexateIncidenceEfficacyPrognosisDosingAdministrationSingle agents vs combination chemotherapy in relapsed and refractory peripheral T‐cell lymphoma: Results from the comprehensive oncology measures for peripheral T‐cell lymphoma treatment (COMPLETE) registry
Stuver RN, Khan N, Schwartz M, Acosta M, Federico M, Gisselbrecht C, Horwitz SM, Lansigan F, Pinter‐Brown L, Pro B, Shustov AR, Foss FM, Jain S. Single agents vs combination chemotherapy in relapsed and refractory peripheral T‐cell lymphoma: Results from the comprehensive oncology measures for peripheral T‐cell lymphoma treatment (COMPLETE) registry. American Journal Of Hematology 2019, 94: 641-649. PMID: 30896890, PMCID: PMC7928240, DOI: 10.1002/ajh.25463.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaComprehensive Oncology MeasuresT-cell lymphomaCombination chemotherapyFirst retreatmentSingle agentCombination therapyR diseaseTreatment RegistryEligibility criteriaR Peripheral T Cell LymphomaHematopoietic stem cell transplantationPrior systemic therapyComplete response rateMedian overall survivalProgression-free survivalStem cell transplantationPrimary endpointAdverse eventsOverall survivalSystemic therapyMore patientsRandomized trialsGrade 3
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 time
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 response
2015
Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma
Iyer SP, Foss FF. Romidepsin for the Treatment of Peripheral T‐Cell Lymphoma. The Oncologist 2015, 20: 1084-1091. PMID: 26099743, PMCID: PMC4571813, DOI: 10.1634/theoncologist.2015-0043.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaT-cell lymphomaHistone deacetylase inhibitorsPrior therapySpecialty centersTherapeutic approachesExpert hematopathologistsTreatment of PTCLDeacetylase inhibitorsPivotal phase II studiesCutaneous T-cell lymphomaPrior systemic therapyCommon adverse eventsObjective response ratePhase II studyFirst-line treatmentTreatment of patientsNon-Hodgkin lymphomaDifficulty of diagnosisAsthenic conditionsHeavy pretreatmentInduction chemotherapyAdvanced diseaseAdverse eventsBelinostat 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 studiesImmunotoxinTrialsPhase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma
Duvic M, Pinter-Brown LC, Foss FM, Sokol L, Jorgensen JL, Challagundla P, Dwyer KM, Zhang X, Kurman MR, Ballerini R, Liu L, Kim YH. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma. Blood 2015, 125: 1883-1889. PMID: 25605368, PMCID: PMC4375715, DOI: 10.1182/blood-2014-09-600924.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaEfficacy of mogamulizumabT-cell lymphomaAnti-CC chemokine receptor 4 monoclonal antibodyFrequent treatment-emergent adverse eventsCutaneous T-cell lymphoma patientsTreatment-emergent adverse eventsT-cell lymphoma patientsSignificant hematologic effectsInfusion-related reactionsPhase 1/2 studyOverall response ratePhase 3 investigationAnti-CCR4 antibodyEvaluable patientsBlood involvementAdverse eventsGrade 1/2Sézary syndromeComplete responseMycosis fungoidesLymphoma patientsHematologic effectsDisease progressionMogamulizumab
2014
A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma
Foss F, Advani R, Duvic M, Hymes KB, Intragumtornchai T, Lekhakula A, Shpilberg O, Lerner A, Belt RJ, Jacobsen ED, Laurent G, Ben‐Yehuda D, Beylot‐Barry M, Hillen U, Knoblauch P, Bhat G, Chawla S, Allen LF, Pohlman B. A Phase II trial of Belinostat (PXD101) in patients with relapsed or refractory peripheral or cutaneous T‐cell lymphoma. British Journal Of Haematology 2014, 168: 811-819. PMID: 25404094, DOI: 10.1111/bjh.13222.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic AgentsDrug Administration ScheduleFemaleHistone Deacetylase InhibitorsHumansHydroxamic AcidsInfusions, IntravenousLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm StagingRecurrenceSulfonamidesTreatment OutcomeYoung AdultConceptsCutaneous T-cell lymphomaPeripheral T-cell lymphomaObjective response rateT-cell lymphomaPrior systemic therapyStage IV diseaseSystemic therapyAdverse eventsTreatment-related serious adverse eventsRefractory peripheral T-cell lymphomaTreatment-related adverse eventsPan-histone deacetylase inhibitorInfusion site painSkin-directed therapiesGrade 4 thrombocytopeniaSerious adverse eventsPhase II trialJugular vein thrombosisAnti-angiogenic propertiesOpen labelII trialParalytic ileusPeripheral edemaPrimary endpointSite painTolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma
Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomarker Research 2014, 2: 16. PMID: 25279222, PMCID: PMC4181623, DOI: 10.1186/2050-7771-2-16.Peer-Reviewed Original ResearchMajority of discontinuationsCommon adverse eventsRefractory PTCLAdverse eventsT-cell lymphomaHematologic toxicityAE profileRomidepsin treatmentGreater incidencePoor bone marrow reserveCutaneous T-cell lymphomaRefractory T-cell lymphomaBone marrow reserveDose of romidepsinFrequent hematologic toxicityLeast stable diseaseSimilar AE profilesTreatment cycles 1Severe hematologic toxicityDurable clinical responsesRefractory aggressive lymphomaOverall clinical benefitCycle 1Overall AE profileNovel drug therapies
2013
A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study
Foss FM, Sjak-Shie N, Goy A, Jacobsen E, Advani R, Smith MR, Komrokji R, Pendergrass K, Bolejack V. A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study. Leukemia & Lymphoma 2013, 54: 1373-1379. PMID: 23278639, DOI: 10.3109/10428194.2012.742521.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaDenileukin diftitoxT-cell lymphomaAdverse eventsOverall survivalFrequent treatment-related adverse eventsUntreated peripheral T-cell lymphomaMedian progression-free survivalMost frequent adverse eventsMulticenter phase II trialTreatment-related adverse eventsTreatment-related deathsFrequent adverse eventsMedian overall survivalPhase II studyPhase II trialProgression-free survivalOverall survival rateOverall response rateITT populationSafety populationII trialII studyMedian durationLarge trials