Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
Foss F, Kim Y, Prince H, Akilov O, Querfeld C, Seminario-Vidal L, Fisher D, Kuzel T, Yannakou C, Geskin L, Feldman T, Sokol L, Allen P, Dang N, Cabanillas F, Wong H, Ooi C, Xing D, Sauter N, Singh P, Czuczman M, Duvic M. Efficacy and Safety of Denileukin Diftitox-Cxdl, an Improved Purity Formulation of Denileukin Diftitox, in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma. Journal Of Clinical Oncology 2024, 43: 1198-1209. PMID: 39700456, PMCID: PMC11949209, DOI: 10.1200/jco-24-01549.Peer-Reviewed Original ResearchConceptsCutaneous T-cell lymphomaTreatment-emergent adverse eventsTime to responseT-cell lymphomaTumor burdenRefractory cutaneous T-cell lymphomaEnd pointsEfficacy end pointCapillary leak syndromePrimary efficacy analysisSecondary end pointsHuman interleukin-2Unmet medical needMedian DoRSystemic therapyInfusion reactionsOpen-labelDenileukin diftitoxEfficacy analysisAdverse eventsInterleukin-2Safety resultsQ1-Q3PatientsResponse rateSafety 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, 26: 110-122. 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
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