2020
Phase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome
Holkova B, Shafer D, Yazbeck V, Dave S, Bose P, Tombes MB, Shrader E, Wan W, Bandyopadhyay D, Weir C, Collins EB, Garnett A, Kmieciak M, Roberts JD, Garcia-Manero G, Grant S. Phase 1 study of belinostat (PXD-101) and bortezomib (Velcade, PS-341) in patients with relapsed or refractory acute leukemia and myelodysplastic syndrome. Leukemia & Lymphoma 2020, 62: 1187-1194. PMID: 33356689, PMCID: PMC8106643, DOI: 10.1080/10428194.2020.1861270.Peer-Reviewed Original ResearchConceptsStable diseaseAcute leukemiaDay 1Phase 1 dose-escalation studyRefractory acute leukemiaDose-escalation studyPhase 1 studyWhole-exome sequencingComplete pathologicKaryotypic responseAdult patientsQTc prolongationFirst patientMyelodysplastic syndromeTreatment strategiesBlast crisisPatientsExceptional responseKaryotypic aberrationsBelinostatGood responseBortezomibAMLLeukemiaFurther investigation
2017
A 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
Holkova B, Yazbeck V, Kmieciak M, Bose P, Ma S, Kimball A, Tombes MB, Shrader E, Wan W, Weir-Wiggins C, Singh A, Hogan KT, Conine S, Sankala H, Roberts JD, Shea TC, Grant S. A 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. Leukemia & Lymphoma 2017, 58: 1349-1357. PMID: 28103725, PMCID: PMC5817887, DOI: 10.1080/10428194.2016.1276287.Peer-Reviewed Original ResearchConceptsT-cell lymphomaMaximum-tolerated doseDose-limiting toxicityPhase 1 studyStable diseaseChronic lymphocytic leukemia/small lymphocytic lymphomaRefractory CLL/SLLPeripheral T-cell lymphomaCutaneous T-cell lymphomaIndolent B-cell lymphomaGrade 3 fatigueMedian treatment durationCLL/SLLSingle-agent bortezomibSmall lymphocytic lymphomaExpression of NFB-cell lymphomaRefractory CLLMedian durationPartial responseProgressive diseaseSafety profileLymphocytic lymphomaTreatment durationDay 1
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