2024
Phase 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
EPOCH Is a Safe and Effective Treatment Option for Aggressive T-Cell Lymphomas
Sethi T, Gerstein R, Schiffer M, Amin K, Agarwal S, Foss F. EPOCH Is a Safe and Effective Treatment Option for Aggressive T-Cell Lymphomas. Blood 2021, 138: 4547. DOI: 10.1182/blood-2021-151238.Peer-Reviewed Original ResearchAggressive T-cell lymphomaCutaneous T-cell lymphomaT-cell lymphomaAnaplastic large cell lymphomaSubcutaneous panniculitis-like T-cell lymphomaAngioimmunoblastic T-cell lymphomaAdult T-cell leukemia/lymphomaProgression-free survivalOverall response rateNon-Hodgkin lymphomaResponse rateR settingOverall survivalCR rateAdverse effectsPanniculitis-like T-cell lymphomaGrade 3 adverse effectsGrade 4 adverse effectsMedian progression-free survivalAllogeneic stem cell transplantPeripheral T-cell lymphomaT-cell leukemia/lymphomaYale-New Haven HospitalFirst lineEfficacy of etoposide
2019
Randomized 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
2018
Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study
Flinn IW, Patel M, Oki Y, Horwitz S, Foss FF, Allen K, Douglas M, Stern H, Sweeney J, Kharidia J, Kelly P, Kelly VM, Kahl B. Duvelisib, an oral dual PI3K‐δ, γ inhibitor, shows clinical activity in indolent non‐Hodgkin lymphoma in a phase 1 study. American Journal Of Hematology 2018, 93: 1311-1317. PMID: 30033575, PMCID: PMC6220789, DOI: 10.1002/ajh.25228.Peer-Reviewed Original ResearchConceptsIndolent non-Hodgkin lymphomaDose-limiting toxicityNon-Hodgkin lymphomaClinical activityINHL patientsHematologic malignanciesClinical developmentGrade 3 transaminase elevationMedian progression-free survivalOral dual inhibitorAcute respiratory failureE. coli sepsisElevated liver enzymesOpen-label studyAcceptable safety profileAdvanced hematologic malignanciesDose-escalation phaseGrade 3 rashProgression-free survivalSevere adverse eventsPhase 1 studyDuration of responseFavorable clinical activityFurther clinical developmentBID cohort
2014
Romidepsin 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
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
2012
Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study
Foss F, Horwitz SM, Coiffier B, Bartlett N, Popplewell L, Pro B, Pinter-Brown LC, Shustov A, Furman RR, Haioun C, Koutsoukos T, O'Connor OA. Pralatrexate Is an Effective Treatment for Relapsed or Refractory Transformed Mycosis Fungoides: A Subgroup Efficacy Analysis From the PROPEL Study. Clinical Lymphoma Myeloma & Leukemia 2012, 12: 238-243. PMID: 22542448, DOI: 10.1016/j.clml.2012.01.010.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalToxicity-related discontinuationProgression-free survivalIndependent central reviewMedian survivalInvestigator assessmentMycosis fungoidesCentral reviewMedian durationAggressive diseaseRetrospective analysisGrade 4 adverse eventsPrior systemic therapySubgroup efficacy analysesObjective response rateTransformed Mycosis FungoidesPROPEL StudyAdverse eventsObjective responseSystemic therapyCutaneous lesionsEfficacy analysisPoor prognosisTreatment optionsMedian number
2002
A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96
Bailey HH, Levy D, Harris LS, Schink JC, Foss F, Beatty P, Wadler S. A Phase II Trial of Daily Perillyl Alcohol in Patients with Advanced Ovarian Cancer: Eastern Cooperative Oncology Group Study E2E96. Gynecologic Oncology 2002, 85: 464-468. PMID: 12051875, DOI: 10.1006/gyno.2002.6647.Peer-Reviewed Original ResearchConceptsProgression-free rateAdvanced ovarian cancerOvarian cancerPerillyl alcoholMedian progression-free survivalPrior platinum-based therapyAdvanced ovarian carcinomaMedian overall survivalObjective response ratePhase II studyPhase II trialProgression-free survivalLDL cholesterol levelsPlatinum-based therapyGastrointestinal toxicityII trialPrimary endpointRecurrent diseaseUnacceptable toxicityII studyOverall survivalPartial responseHistoric controlsCholesterol levelsOvarian carcinoma