2024
TCL-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 age
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 pain
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
2006
A phase II open-label study of recombinant human interleukin-12 in patients with stage IA, IB, or IIA mycosis fungoides
Duvic M, Sherman ML, Wood GS, Kuzel TM, Olsen E, Foss F, Laliberté RJ, Ryan JL, Zonno K, Rook AH. A phase II open-label study of recombinant human interleukin-12 in patients with stage IA, IB, or IIA mycosis fungoides. Journal Of The American Academy Of Dermatology 2006, 55: 807-813. PMID: 17052486, DOI: 10.1016/j.jaad.2006.06.038.Peer-Reviewed Original ResearchConceptsSeverity-weighted assessment toolMonths of therapyPartial responseRhIL-12Mycosis fungoidesAdverse eventsInterleukin-12Phase II open-label studyDuration of PROpen-label clinical trialTreatment-related adverse eventsRecombinant human IL-12Recombinant human interleukin-12Early-stage MFIIA mycosis fungoidesRhIL-12 treatmentOpen-label studyAlanine aminotransferase levelsLabel clinical trialInjection site reactionsNatural killer cellsT cell activityEarly mycosis fungoidesT helper cellsHuman IL-12