2024
Analyzing determinants of premature trial discontinuation in leukemia clinical trials
Rotter L, Alhajahjeh A, Stempel J, Grimshaw A, Bewersdorf J, Blaha O, Kewan T, Podoltsev N, Shallis R, Mendez L, Stahl M, Zeidan A. Analyzing determinants of premature trial discontinuation in leukemia clinical trials. Leukemia & Lymphoma 2024, ahead-of-print: 1-9. PMID: 39440622, DOI: 10.1080/10428194.2024.2416565.Peer-Reviewed Original ResearchClinical trialsSlow accrualLeukemia trialsEarly-phase trialsNon-randomized trialsAcademic-sponsored trialsImprove patient outcomesLeukemia clinical trialsSingle-centerTrial discontinuationSponsored trialsSmall trialsLeukemiaEarly terminationPatient outcomesLate-phaseIndependent reviewersTermination ratesComprehensive searchTrials
2022
Cost-Effectiveness of Azacitidine and Ivosidenib in Newly Diagnosed Older, Intensive Chemotherapy-Ineligible Patients with IDH1-Mutant Acute Myeloid Leukemia
Bewersdorf J, Patel K, Goshua G, Shallis R, Podoltsev N, Stahl M, Stempel J, Stein E, Huntington S, Zeidan A. Cost-Effectiveness of Azacitidine and Ivosidenib in Newly Diagnosed Older, Intensive Chemotherapy-Ineligible Patients with IDH1-Mutant Acute Myeloid Leukemia. Blood 2022, 140: 319-321. DOI: 10.1182/blood-2022-158465.Peer-Reviewed Original ResearchA Multi-Center Phase Ib Trial of the Histone Deactylase Inhibitor (HDACi) Entinostat in Combination with Anti-PD1 Antibody Pembrolizumab in Patients with Refractory/Relapsed Myelodysplastic Syndromes (RR-MDS) or Oligoblastic Acute Myeloid Leukemia (RR-AML) after Hypomethylating Agent (HMA) Failure
Bewersdorf J, Shallis R, Sharon E, Caldwell A, Wei W, Yacoub A, Madanat Y, Zeidner J, Altman J, Odenike O, Yerrabothala S, Kovacsovics T, Podoltsev N, Halene S, Little R, Piekarz R, Gore S, Kim T, Zeidan A. A Multi-Center Phase Ib Trial of the Histone Deactylase Inhibitor (HDACi) Entinostat in Combination with Anti-PD1 Antibody Pembrolizumab in Patients with Refractory/Relapsed Myelodysplastic Syndromes (RR-MDS) or Oligoblastic Acute Myeloid Leukemia (RR-AML) after Hypomethylating Agent (HMA) Failure. Blood 2022, 140: 9084-9086. DOI: 10.1182/blood-2022-158626.Peer-Reviewed Original ResearchCost-effectiveness of liposomal cytarabine/daunorubicin in patients with newly diagnosed acute myeloid leukemia
Bewersdorf JP, Patel KK, Goshua G, Shallis RM, Podoltsev NA, Huntington SF, Zeidan AM. Cost-effectiveness of liposomal cytarabine/daunorubicin in patients with newly diagnosed acute myeloid leukemia. Blood 2022, 139: 1766-1770. PMID: 35298594, PMCID: PMC8931513, DOI: 10.1182/blood.2021014401.Peer-Reviewed Original Research
2021
A Phase I dose‐escalation study of DCLL9718S, an antibody‐drug conjugate targeting C‐type lectin‐like molecule‐1 (CLL‐1) in patients with acute myeloid leukemia
Daver N, Salhotra A, Brandwein JM, Podoltsev NA, Pollyea DA, Jurcic JG, Assouline S, Yee K, Li M, Pourmohamad T, Samineni D, Sumiyoshi T, Vaze A, Dere RC, Ma C, Cooper J. A Phase I dose‐escalation study of DCLL9718S, an antibody‐drug conjugate targeting C‐type lectin‐like molecule‐1 (CLL‐1) in patients with acute myeloid leukemia. American Journal Of Hematology 2021, 96: e175-e179. PMID: 33617672, PMCID: PMC8252033, DOI: 10.1002/ajh.26136.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodiesAntineoplastic AgentsChemical and Drug Induced Liver InjuryDose-Response Relationship, DrugEarly Termination of Clinical TrialsFemaleHumansImmunoconjugatesLectins, C-TypeLeukemia, Myeloid, AcuteMaleMiddle AgedMutationNeoplasm ProteinsNeoplasms, Second PrimaryReceptors, MitogenYoung Adult
2020
Isolated trisomy 11 in patients with acute myeloid leukemia – is the prognosis not as grim as previously thought?*
Bewersdorf JP, Shallis RM, Diadamo A, Gowda L, Podoltsev NA, Siddon A, Zeidan AM. Isolated trisomy 11 in patients with acute myeloid leukemia – is the prognosis not as grim as previously thought?*. Leukemia & Lymphoma 2020, 61: 2254-2257. PMID: 32338096, PMCID: PMC7485109, DOI: 10.1080/10428194.2020.1755858.Peer-Reviewed Original ResearchPatterns of care and clinical outcomes of patients with newly diagnosed acute myeloid leukemia presenting with hyperleukocytosis who do not receive intensive chemotherapy
Shallis RM, Stahl M, Wei W, Montesinos P, Lengline E, Neukirchen J, Bhatt VR, Sekeres MA, Fathi AT, Konig H, Luger S, Khan I, Roboz GJ, Cluzeau T, Martínez-Cuadron D, Raffoux E, Germing U, Umakanthan JM, Mukhereje S, Brunner AM, Miller A, McMahon CM, Ritchie EK, Rodríguez-Veiga R, Itzykson R, Boluda B, Rabian F, Tormo M, Acuña-Cruz E, Rabinovich E, Yoo B, Cano I, Podoltsev NA, Bewersdorf JP, Gore S, Zeidan AM. Patterns of care and clinical outcomes of patients with newly diagnosed acute myeloid leukemia presenting with hyperleukocytosis who do not receive intensive chemotherapy. Leukemia & Lymphoma 2020, 61: 1220-1225. PMID: 32100599, PMCID: PMC8273667, DOI: 10.1080/10428194.2020.1728753.Peer-Reviewed Original Research
2018
A Phase 3 Study of CPX-351 versus Conventional 7+3 Cytarabine and Daunorubicin: Subanalysis of Patients with Secondary Acute Myeloid Leukemia (sAML) with Refractory Anemia with Excess of Blasts in Transformation (RAEB-t)
Lin T, Wieduwilt M, Newell L, Schiller G, Rubenstein S, Stock W, Warlick E, Bixby D, Podoltsev N, An Q, Faderl S, Louie A, Uy G. A Phase 3 Study of CPX-351 versus Conventional 7+3 Cytarabine and Daunorubicin: Subanalysis of Patients with Secondary Acute Myeloid Leukemia (sAML) with Refractory Anemia with Excess of Blasts in Transformation (RAEB-t). Clinical Lymphoma Myeloma & Leukemia 2018, 18: s208. DOI: 10.1016/j.clml.2018.07.063.Peer-Reviewed Original ResearchPerformance of the Medical Research Council (MRC) and the Leukemia Research Foundation (LRF) score in predicting survival benefit with hypomethylating agent use in patients with relapsed or refractory acute myeloid leukemia
Stahl M, DeVeaux M, Montesinos P, Itzykson R, Ritchie EK, Sekeres MA, Barnard J, Podoltsev NA, Brunner A, Komrokji RS, Bhatt VR, Al-Kali A, Cluzeau T, Santini V, Roboz GJ, Fenaux P, Litzow M, Fathi AT, Perreault S, Kim TK, Prebet T, Vey N, Verma V, Germing U, Bergua J, Serrano J, Gore SD, Zeidan AM. Performance of the Medical Research Council (MRC) and the Leukemia Research Foundation (LRF) score in predicting survival benefit with hypomethylating agent use in patients with relapsed or refractory acute myeloid leukemia. Leukemia & Lymphoma 2018, 60: 246-249. PMID: 29963936, DOI: 10.1080/10428194.2018.1468893.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDrug Resistance, NeoplasmFemaleHematopoietic Stem Cell TransplantationHumansLeukemia, Myeloid, AcuteMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisRetrospective StudiesRisk AssessmentRisk FactorsSurvival AnalysisTransplantation, HomologousTreatment OutcomeYoung Adult311 Subanalysis of Patients with Secondary Acute Myeloid Leukemia (sAML) with Refractory Anemia with Excess of Blasts in Transformation (RAEB-T) Enrolled in a Phase 3 Study of CPX-351 Versus Conventional 7 + 3 Cytarabine and Daunorubicin
Lin T, Uy G, Wieduwilt M, Newell L, Stuart R, Medeiros B, Schiller G, Rubenstein S, Stock W, Warlick E, Foster M, Bixby D, Podoltsev N, An Q, Faderl S, Louie A, Lancet J. 311 Subanalysis of Patients with Secondary Acute Myeloid Leukemia (sAML) with Refractory Anemia with Excess of Blasts in Transformation (RAEB-T) Enrolled in a Phase 3 Study of CPX-351 Versus Conventional 7 + 3 Cytarabine and Daunorubicin. Transplantation And Cellular Therapy 2018, 24: s228-s229. DOI: 10.1016/j.bbmt.2017.12.209.Peer-Reviewed Original Research
2017
Overall Survival (OS) and Stem Cell Transplant (SCT) in Patients with FLT3 Mutations Treated with CPX-351 versus 7+3: Subgroup Analysis of a Phase 3 Study of Older Adults with Newly Diagnosed, High-Risk Acute Myeloid Leukemia (AML)
Medeiros B, Hogge D, Newell L, Bixby D, Solomon S, Strickland S, Lin T, Erba H, Powell B, Podoltsev N, Ryan R, Chiarella M, Louie A, Lancet J. Overall Survival (OS) and Stem Cell Transplant (SCT) in Patients with FLT3 Mutations Treated with CPX-351 versus 7+3: Subgroup Analysis of a Phase 3 Study of Older Adults with Newly Diagnosed, High-Risk Acute Myeloid Leukemia (AML). Clinical Lymphoma Myeloma & Leukemia 2017, 17: s286. DOI: 10.1016/j.clml.2017.07.071.Peer-Reviewed Original Research32 Hypomethylating Agent Therapy use and Survival in Older Patients with Chronic Myelomonocytic Leukemia in USA: A Large Population-Based Study
Zeidan A, Hu X, Long J, Wang R, Ma X, Podoltsev N, Huntington S, Gore S, Davidoff A. 32 Hypomethylating Agent Therapy use and Survival in Older Patients with Chronic Myelomonocytic Leukemia in USA: A Large Population-Based Study. Leukemia Research 2017, 55: s20-s21. DOI: 10.1016/s0145-2126(17)30145-5.Peer-Reviewed Original Research
2016
Hypomethylating Agent Therapy and Survival Among Older Patients with Chronic Myelomonocytic Leukemia in the United States: A Large Population-Based Study
Zeidan A, Hu X, Long J, Wang R, Huntington S, Podoltsev N, Gore S, Ma X, Davidoff A. Hypomethylating Agent Therapy and Survival Among Older Patients with Chronic Myelomonocytic Leukemia in the United States: A Large Population-Based Study. Blood 2016, 128: 394. DOI: 10.1182/blood.v128.22.394.394.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaMyelodysplastic syndromeSurvival benefitHigh-risk myelodysplastic syndromeDemonstrated survival benefitRetrospective cohort studyRisk myelodysplastic syndromesUse of HMAsAgent azacitidineLack of evidenceCohort studyClinical entityMyelomonocytic leukemiaBiologic evidenceOlder adultsAzacitidineUnited StatesHMAsEnd resultPatientsSyndromeLeukemiaDecitabineEpidemiologySelecting initial treatment of acute myeloid leukaemia in older adults
Podoltsev NA, Stahl M, Zeidan AM, Gore SD. Selecting initial treatment of acute myeloid leukaemia in older adults. Blood Reviews 2016, 31: 43-62. PMID: 27745715, DOI: 10.1016/j.blre.2016.09.005.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaTreatment-related mortalityInduction chemotherapyComplete remissionInitial treatmentMyeloid leukemiaNovel agentsOlder adultsMedian overall survivalGroup of patientsPhase III developmentDisease-related characteristicsMechanism of actionCPX-351Overall survivalLow-intensity treatmentClinical trialsTreatment outcomesPatientsRemissionChemotherapyLeukemiaMortalityTreatmentAdultsSingle agent blinatumumab as frontline therapy for an 85-year-old patient with B cell precursor acute lymphoblastic leukemia
Kim TK, Xu ML, Podoltsev NA, Prebet T, Barbarotta L, Amin K, Kasberg S, Roche K, Stahl M, Gore SD, Zeidan AM. Single agent blinatumumab as frontline therapy for an 85-year-old patient with B cell precursor acute lymphoblastic leukemia. Annals Of Hematology 2016, 95: 1895-1898. PMID: 27468851, PMCID: PMC10955604, DOI: 10.1007/s00277-016-2761-4.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAged, 80 and overAntibodies, BispecificAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBone MarrowBreast NeoplasmsCarcinoma, Transitional CellCytarabineFemaleHumansLymphoma, B-CellMercaptopurineMethotrexateNeoplasms, Second PrimaryPrecursor B-Cell Lymphoblastic Leukemia-LymphomaPrednisoneRemission InductionSalvage TherapyUrinary Bladder NeoplasmsVincristine
2015
Patterns of Venous Thromboembolism Prophylaxis During Treatment of Acute Leukemia: Results of a North American Web-Based Survey
Lee EJ, Smith BD, Merrey JW, Lee AI, Podoltsev NA, Barbarotta L, Litzow MR, Prebet T, Luger SM, Gore S, Streiff MB, Zeidan AM. Patterns of Venous Thromboembolism Prophylaxis During Treatment of Acute Leukemia: Results of a North American Web-Based Survey. Clinical Lymphoma Myeloma & Leukemia 2015, 15: 766-770.e4. PMID: 26363982, PMCID: PMC4663156, DOI: 10.1016/j.clml.2015.07.637.Peer-Reviewed Original ResearchConceptsVenous thromboembolismAcute leukemiaVTE prophylaxisPrevention of VTEPharmacologic VTE prophylaxisVenous thromboembolism prophylaxisEvidence-based guidelinesHigh-quality studiesConsolidation therapyPharmacologic prophylaxisThromboembolism prophylaxisNorth American providersVTE preventionSignificant morbidityProspective studyPatient populationHigh riskProphylaxisLower riskResponse ratePatientsWeb-based surveyLeukemiaSpectrum of practicesAmerican providersPhase I/IIa trial of volasertib combined with decitabine in patients with acute myeloid leukemia (AML) ineligible for intensive therapy
Cortes J, Podoltsev N, Rajeswari S, Guo Z, Taube T, Uy G. Phase I/IIa trial of volasertib combined with decitabine in patients with acute myeloid leukemia (AML) ineligible for intensive therapy. Clinical Lymphoma Myeloma & Leukemia 2015, 15: s193. DOI: 10.1016/j.clml.2015.04.043.Peer-Reviewed Original ResearchUse of arsenic trioxide in a hemodialysis-dependent patient with relapsed acute promyelocytic leukemia
Perreault S, Moeller J, Patel K, Eyler R, Pham T, Russell K, Podoltsev N. Use of arsenic trioxide in a hemodialysis-dependent patient with relapsed acute promyelocytic leukemia. Journal Of Oncology Pharmacy Practice 2015, 22: 646-651. PMID: 25972392, DOI: 10.1177/1078155215586235.Peer-Reviewed Original ResearchConceptsHemodialysis-dependent patientsAcute promyelocytic leukemiaArsenic trioxidePromyelocytic leukemiaPre-existing cardiac conditionsRelapsed acute promyelocytic leukemiaSevere renal impairmentFront-line treatmentPaucity of dataRenal impairmentDialysis patientsDose adjustmentHemodialysis patientsCardiac conditionsPatientsThree timesLeukemiaRegimenDialysisImpairmentMarginal amount
2014
Enhanced skin toxicity associated with the combination of clofarabine plus cytarabine for the treatment of acute leukemia
Zhang B, Bolognia J, Marks P, Podoltsev N. Enhanced skin toxicity associated with the combination of clofarabine plus cytarabine for the treatment of acute leukemia. Cancer Chemotherapy And Pharmacology 2014, 74: 303-307. PMID: 24908437, DOI: 10.1007/s00280-014-2504-y.Peer-Reviewed Original ResearchConceptsAcute leukemiaSkin toxicityCombination of clofarabineInitiation of chemotherapyPalmar-plantar erythrodysesthesiaCutaneous side effectsTwo-drug combinationsDifferent chemotherapeutic agentsCytarabine chemotherapyCytarabine groupResultsTen patientsCutaneous toxicityToxic erythemaCutaneous reactionsSkin findingsMedical recordsInstitutional experienceSevere formSide effectsPatientsBody foldsClofarabineChemotherapeutic agentsChemotherapyLeukemia