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
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
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 transplantBelinostat 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
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
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 3Randomized 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 therapy
2017
Erratum to: Romidepsin 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, Miles Prince H, Sokol L, Balser B, Wolfson J, Coiffier B. Erratum to: 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 2017, 10: 154. PMID: 28923081, PMCID: PMC5603163, DOI: 10.1186/s13045-017-0518-8.Peer-Reviewed Original ResearchRefractory peripheral T-cell lymphomaPeripheral T-cell lymphomaT-cell lymphomaStable diseasePivotal trialsClinical benefitCell lymphomaPatientsLymphomaDiseaseTrials
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 responseRomidepsin 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 responseRomidepsin 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 eventsUtility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma
Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of18fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Annals Of Oncology 2015, 26: 774-779. PMID: 25605745, PMCID: PMC4374388, DOI: 10.1093/annonc/mdv010.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaInternational Workshop CriteriaFDG-PET scansRefractory peripheral T-cell lymphomaBaseline FDG-PET scanCR/CRuT-cell lymphomaPositron emission tomographyConventional radiologyPET criteriaStable diseaseEnd pointFDG-PETConventional stagingPET statusResponse assessmentPivotal phase 2 trialEmission tomographyDeoxyglucose positron emission tomographyExploratory end pointsObjective response ratePET-positive diseasePrimary end pointProgression-free survivalPhase 2 study
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 painRomidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. Journal Of Hematology & Oncology 2014, 7: 11. PMID: 24456586, PMCID: PMC4016573, DOI: 10.1186/1756-8722-7-11.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibiotics, AntineoplasticCellulitisDepsipeptidesDisease-Free SurvivalDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansInfusions, IntravenousLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRemission InductionTime FactorsTreatment OutcomeVenous ThrombosisVomitingConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaCR/CRuDuration of responseObjective response rateT-cell lymphomaDurable responsesPrior therapySystemic therapyMedian DORMedian progression-free survivalCutaneous T-cell lymphomaReported safety profileProgression-free survivalUnconfirmed complete responseSubset of patientsLong-term responseIndependent review committeeTreatment of patientsSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsLack of responseHeavy pretreatmentStable diseasePrimary endpoint
2012
Pralatrexate: treatment of T-cell non-Hodgkins lymphoma
Parker T, Barbarotta L, Foss F. Pralatrexate: treatment of T-cell non-Hodgkins lymphoma. Future Oncology 2012, 9: 21-29. PMID: 23252560, DOI: 10.2217/fon.12.168.Peer-Reviewed Original ResearchConceptsRefractory peripheral T-cell lymphomaPeripheral T-cell lymphomaT-cell non-Hodgkin lymphomaVitamin B12 supplementationOverall response rateNon-Hodgkin lymphomaT-cell lymphomaPROPEL trialCommon toxicitiesB12 supplementationPatient populationClinical studiesResponse ratePralatrexateUS FDALymphomaMetabolic inhibitorsTreatmentToxicityNauseaThrombocytopeniaDoseTrialsSupplementationWeeksResults From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy
Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy. Journal Of Clinical Oncology 2012, 30: 631-636. PMID: 22271479, DOI: 10.1200/jco.2011.37.4223.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibiotics, AntineoplasticDepsipeptidesDiarrheaDisease-Free SurvivalDrug Administration ScheduleFemaleFollow-Up StudiesHumansKaplan-Meier EstimateLymphoma, T-Cell, PeripheralMaleMiddle AgedNeoplasm Recurrence, LocalPneumoniaTreatment OutcomeVascular DiseasesVomitingYoung AdultConceptsPeripheral T-cell lymphomaRefractory peripheral T-cell lymphomaPrior systemic therapyCR/CRuSystemic therapyT-cell lymphomaPrior therapyComplete response/unconfirmed complete responseResponse ratePrior stem cell transplantationEfficacy of romidepsinSingle-agent romidepsinObjective response ratePhase II studyPrimary end pointPhase II trialUnconfirmed complete responseStem cell transplantationIndependent review committeeDrug Administration approvalSelective histone deacetylase inhibitorsHistone deacetylase inhibitorsManageable toxicityII trialOpen label
2011
Evaluation of the pharmacokinetics, preclinical and clinical efficacy of pralatrexate for the treatment of T-cell lymphoma
Foss FM. Evaluation of the pharmacokinetics, preclinical and clinical efficacy of pralatrexate for the treatment of T-cell lymphoma. Expert Opinion On Drug Metabolism & Toxicology 2011, 7: 1141-1152. PMID: 21726160, DOI: 10.1517/17425255.2011.595404.Peer-Reviewed Original ResearchConceptsPeripheral T-cell lymphomaT-cell lymphomaRefractory peripheral T-cell lymphomaPhase I/II trialEarly phase I/II trialsCutaneous T-cell lymphomaAggressive T-cell lymphomaT-cell lymphoma subtypesFrequent adverse eventsStem cell transplantationT-cell neoplasmsII trialAdverse eventsMost patientsHodgkin's diseasePreclinical findingsClinical efficacyLymphoma trialsPoor outcomeConventional therapyHodgkin's lymphomaReversible thrombocytopeniaHematologic malignanciesClinical trialsClinical studies
2005
Activity of Gallium Nitrate in Refractory Peripheral T-Cell Lymphoma
Huang Z, Higgins B, Foss F. Activity of Gallium Nitrate in Refractory Peripheral T-Cell Lymphoma. Clinical Lymphoma Myeloma & Leukemia 2005, 6: 43-45. PMID: 15989706, DOI: 10.3816/clm.2005.n.026.Peer-Reviewed Original Research