2014
Phase 1 Study of Bortezomib and Romidepsin in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, Peripheral T-Cell Lymphoma, or Cutaneous T-Cell Lymphoma: Updated Results
Holkova B, Kmieciak M, Bose P, Ma S, Kimball A, Tombes M, Shrader E, Wan W, Weir-Wiggins C, Stoddert E, Singh A, Dean A, Conine S, Sankala H, Roberts J, Shea T, Grant S. Phase 1 Study of Bortezomib and Romidepsin in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, Peripheral T-Cell Lymphoma, or Cutaneous T-Cell Lymphoma: Updated Results. Blood 2014, 124: 3050. DOI: 10.1182/blood.v124.21.3050.3050.Peer-Reviewed Original ResearchCutaneous T-cell lymphomaPeripheral T-cell lymphomaDose level 2aIndolent B-cell lymphomaT-cell lymphomaSmall lymphocytic lymphomaRefractory CLL/small lymphocytic lymphomaB-cell lymphomaCLL/small lymphocytic lymphomaDose level 1Adverse eventsLymphocytic lymphomaChronic lymphocytic leukemia/small lymphocytic lymphomaGrade 2 adverse eventsGrade 3 adverse eventsLevel 2bLevel 2aGrade 3 fatigueGrade 3 vomitingReversible grade 2Cytokine release syndromeGrade 4 neutropeniaECOG performance scorePhase 1 studySoft tissue infections
2012
Phase I Study of Bortezomib and Romidepsin in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, or Peripheral T-Cell Lymphoma
Holkova B, Shea T, Bose P, Tombes M, Shrader E, Wan W, Weir-Wiggins C, Stoddert E, Sankala H, Kmieciak M, Roberts J, Grant S. Phase I Study of Bortezomib and Romidepsin in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Indolent B-Cell Lymphoma, or Peripheral T-Cell Lymphoma. Blood 2012, 120: 1794. DOI: 10.1182/blood.v120.21.1794.1794.Peer-Reviewed Original ResearchPeripheral T-cell lymphomaIndolent B-cell lymphomaDose level 2aSoft tissue infectionsCLL/SLLT-cell lymphomaAdverse eventsSmall lymphocytic lymphomaB-cell lymphomaTissue infectionsLymphocytic lymphomaGrade 3Grade 2 cytokine release syndromeChronic lymphocytic leukemia/small lymphocytic lymphomaRefractory CLL/SLLLevel 2bCTCAE version 4DLT-evaluable patientsReversible grade 2Cytokine release syndromeDose level 1Grade 4 neutropeniaNausea/vomitingSerious adverse eventsECOG performance scorePhase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory Indolent B-Cell Neoplasms - Update of the “Bolus” Infusion Schedule of Alvocidib.
Holkova B, Perkins E, Bose P, Sullivan D, Baz R, Tombes M, Shrader E, Ramakrishnan V, Wan W, Sankala H, Kmieciak M, Roberts J, Grant S. Phase I Trial of Bortezomib (PS-341; NSC 681239) and Alvocidib (Flavopiridol; NSC 649890) in Patients with Recurrent or Refractory Indolent B-Cell Neoplasms - Update of the “Bolus” Infusion Schedule of Alvocidib. Blood 2012, 120: 2959. DOI: 10.1182/blood.v120.21.2959.2959.Peer-Reviewed Original ResearchAdverse eventsInfusion scheduleMultiple myelomaI trialDose levelsAbsolute neutrophil count decreaseGrade 2 adverse eventsCTCAE version 4Grade 5 eventsIndolent B-cell neoplasmsNeutrophil count decreasePrior systemic therapyPhase II studyECOG performance scoreRefractory multiple myelomaTreatment of recurrentTumor lysis syndromePhase I trialSchedule of administrationCombination of bortezomibIndolent B-cellExpression of pJNKB-cell neoplasmsNF-κB DNA bindingMcl-1
2011
A Phase II Study of the MEK 1/2 Inhibitor AZD6244 (Selumetinib, ARRY-142866) in Relapsed or Refractory Multiple Myeloma
Holkova B, Badros A, Geller R, Voorhees P, Zingone A, Korde N, Lin H, Tombes M, Shrader E, Sankala H, Kmieciak M, Roberts J, Sullivan D, Landgren O, Grant S. A Phase II Study of the MEK 1/2 Inhibitor AZD6244 (Selumetinib, ARRY-142866) in Relapsed or Refractory Multiple Myeloma. Blood 2011, 118: 2931. DOI: 10.1182/blood.v118.21.2931.2931.Peer-Reviewed Original ResearchPhase II studyAspartate aminotransferaseRefractory MMII studyCommon treatment-related adverse eventsPresent phase II studyTreatment-related adverse eventsTwo-stage Simon designAcute kidney injuryCommon grade 3Objective partial responsePeripheral sensory neuropathyECOG performance scoreRefractory multiple myelomaFavorable clinical profilePre-clinical activityResponse/resistanceEffects of AZD6244Multiple myeloma cellsCompetitive small molecule inhibitorBone marrow microenvironmentPost-treatment expressionOrtho BiotechPrior regimensStable diseaseA Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-Cell Lymphoma
Holkova B, Perkins E, Sokol L, Richards K, Parekh S, Elstrom R, Badros A, Espinoza-Delgado I, Schell M, Kimball A, Tombes M, Shrader E, Sankala H, Coppola D, Kmieciak M, Sullivan D, Roberts J, Grant S. A Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-Cell Lymphoma. Blood 2011, 118: 779. DOI: 10.1182/blood.v118.21.779.779.Peer-Reviewed Original ResearchDiffuse large B-cell lymphomaRefractory diffuse large B-cell lymphomaMantle cell lymphomaLarge B-cell lymphomaB-cell lymphomaResponse rateCohort BCohort ACell lymphomaDay 1Common treatment-related adverse eventsPan-HDAC inhibitor vorinostatTreatment-related adverse eventsCommon grade 3Peripheral sensory neuropathyPhase II studySpeakers bureauECOG performance scorePhase II trialSchedule of administrationPhase I studiesCombination of bortezomibNumerous preclinical studiesB-cell malignanciesProteasome inhibitor bortezomib