2018
Duvelisib, an oral dual PI3K‐δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a phase 1 study
O'Brien S, Patel M, Kahl BS, Horwitz SM, Foss FM, Porcu P, Jones J, Burger J, Jain N, Allen K, Faia K, Douglas M, Stern HM, Sweeney J, Kelly P, Kelly V, Flinn I. Duvelisib, an oral dual PI3K‐δ,γ inhibitor, shows clinical and pharmacodynamic activity in chronic lymphocytic leukemia and small lymphocytic lymphoma in a phase 1 study. American Journal Of Hematology 2018, 93: 1318-1326. PMID: 30094870, PMCID: PMC8260004, DOI: 10.1002/ajh.25243.Peer-Reviewed Original ResearchConceptsChronic lymphocytic leukemiaPhase 1 studyTN patientsRR patientsLymphocytic lymphomaLymphocytic leukemiaRefractory chronic lymphocytic leukemiaMedian response durationAdvanced hematologic malignanciesPhase 3 studyOverall response rateCLL/SLLSmall lymphocytic lymphomaPatient's diarrheaExpansion cohortTransaminase elevationHematologic malignanciesPharmacodynamic activityResponse durationPatientsResponse rateΓ inhibitorDuvelisibDual inhibitorLymphoma
2016
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, 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
2012
Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma
Horwitz SM, Kim YH, Foss F, Zain JM, Myskowski PL, Lechowicz MJ, Fisher DC, Shustov AR, Bartlett NL, Delioukina ML, Koutsoukos T, Saunders ME, O'Connor OA, Duvic M. Identification of an active, well-tolerated dose of pralatrexate in patients with relapsed or refractory cutaneous T-cell lymphoma. Blood 2012, 119: 4115-4122. PMID: 22394596, DOI: 10.1182/blood-2011-11-390211.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAminopterinAntimetabolites, AntineoplasticDisease ProgressionDose-Response Relationship, DrugDrug Administration ScheduleDrug EruptionsFatigueFemaleGastrointestinal DiseasesHumansLymphoma, T-Cell, CutaneousMaleMiddle AgedMucositisNeutropeniaSalvage TherapySkin NeoplasmsThrombocytopeniaConceptsCutaneous T-cell lymphomaRefractory cutaneous T-cell lymphomaT-cell lymphomaAdverse eventsSystemic therapyPrimary cutaneous anaplastic large cell lymphomaCommon grade 3 adverse eventsOnly grade 4 adverse eventCutaneous anaplastic large cell lymphomaGrade 3 adverse eventsGrade 4 adverse eventsAnaplastic large cell lymphomaPrior systemic therapyAcceptable toxicity profileLong-term dosingLarge cell lymphomaFolate carrier 1De-escalation strategiesAcceptable toxicityExpansion cohortStarting doseSézary syndromeSystemic treatmentDosing regimenMycosis fungoides