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 searchTrialsAcute myeloid leukemia (AML) with chromosome 3 inversion: biology, management, and clinical outcome
Alhajahjeh A, Bewersdorf J, Bystrom R, Zeidan A, Shimony S, Stahl M. Acute myeloid leukemia (AML) with chromosome 3 inversion: biology, management, and clinical outcome. Leukemia & Lymphoma 2024, ahead-of-print: 1-11. PMID: 38962996, DOI: 10.1080/10428194.2024.2367040.Peer-Reviewed Original ResearchAcute myeloid leukemiaIntensive chemotherapyHypomethylating agentsMyeloid leukemiaAllogeneic stem cell transplantationAcute myeloid leukemia casesAcute myeloid leukemia subtypesStem cell transplantationComplex hematological malignancyCurrent treatment modalitiesRare genetic anomalyCell transplantationHematologic malignanciesTreatment modalitiesClinical outcomesTreatment responseInv(3Genetic alterationsLeukemia developmentTreatment strategiesCellular processesGenetic anomaliesLeukemiaFusion geneClinical implications
2023
Are We Ready For “Triplet” Therapy in Higher-Risk MDS?
Brunner A, Platzbecker U, DeZern A, Zeidan A. Are We Ready For “Triplet” Therapy in Higher-Risk MDS? Clinical Hematology International 2023, 5: 23-32. PMID: 37933301, PMCID: PMC10625655, DOI: 10.46989/001c.88301.Peer-Reviewed Original ResearchAcute myeloid leukemiaCombination chemotherapyPatient populationOnly disease-modifying therapyNovel combination chemotherapyOngoing therapeutic challengeOlder patient populationUnique patient populationDisease-modifying therapiesCurrent treatment paradigmsTherapeutic challengeTreatment paradigmEffective therapyMyeloid leukemiaNew therapiesAppropriate endpointsTherapyChemotherapyComorbiditiesPatientsTransplantNeoplasmsLeukemiaPopulationDecitabineStandardising acute myeloid leukaemia classification systems: a perspective from a panel of international experts
Shallis R, Daver N, Altman J, Komrokji R, Pollyea D, Badar T, Bewersdorf J, Bhatt V, de Botton S, de la Fuente Burguera A, Carraway H, Desai P, Dillon R, Duployez N, El Chaer F, Fathi A, Freeman S, Gojo I, Grunwald M, Jonas B, Konopleva M, Lin T, Mannis G, Mascarenhas J, Michaelis L, Mims A, Montesinos P, Pozdnyakova O, Pratz K, Schuh A, Sekeres M, Smith C, Stahl M, Subklewe M, Uy G, Voso M, Walter R, Wang E, Zeidner J, Žučenka A, Zeidan A. Standardising acute myeloid leukaemia classification systems: a perspective from a panel of international experts. The Lancet Haematology 2023, 10: e767-e776. PMID: 37572683, DOI: 10.1016/s2352-3026(23)00159-x.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaMyeloid leukemiaClinical trial eligibilityInternational consensus classificationHeath care providersHealth care providersTrial eligibilityClassification systemResponse assessmentDisease definitionConsensus classificationPatientsDrug developmentLeukemiaConsistent management strategiesInternational expertsRegulatory pathwaysProvidersHematopathologistsCliniciansDiagnosisWhat’s Next after Hypomethylating Agents Failure in Myeloid Neoplasms? A Rational Approach
Awada H, Gurnari C, Xie Z, Bewersdorf J, Zeidan A. What’s Next after Hypomethylating Agents Failure in Myeloid Neoplasms? A Rational Approach. Cancers 2023, 15: 2248. PMID: 37190176, PMCID: PMC10137017, DOI: 10.3390/cancers15082248.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsAcute myeloid leukemiaMDS/AML patientsEarly clinical trialsPotential therapeutic agentAML patientsMultidrug combinationsClinical trialsMyeloid leukemiaMyeloid neoplasmsRational approachSingle agentCurrent managementTherapeutic potentialStandardized guidelinesTherapeutic agentsMutational characteristicsPatientsNeoplasmsLatest findingsGenomic factorsCellular adaptationAgentsHMA resistanceFailureLeukemia
2022
Prognostic implications of mono-hit and multi-hit TP53 alterations in patients with acute myeloid leukemia and higher risk myelodysplastic syndromes treated with azacitidine-based therapy
Zeidan A, Bewersdorf J, Hasle V, Shallis R, Thompson E, de Menezes D, Rose S, Boss I, Halene S, Haferlach T, Fox B. Prognostic implications of mono-hit and multi-hit TP53 alterations in patients with acute myeloid leukemia and higher risk myelodysplastic syndromes treated with azacitidine-based therapy. Leukemia 2022, 37: 240-243. PMID: 36437356, DOI: 10.1038/s41375-022-01766-z.Peer-Reviewed Original ResearchTP53‐altered acute myeloid leukemia and myelodysplastic syndrome with excess blasts should be approached as a single entity
Shallis R, Daver N, Altman J, Hasserjian R, Kantarjian H, Platzbecker U, Santini V, Wei A, Sallman D, Zeidan A. TP53‐altered acute myeloid leukemia and myelodysplastic syndrome with excess blasts should be approached as a single entity. Cancer 2022, 129: 175-180. PMID: 36397669, DOI: 10.1002/cncr.34535.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsCost-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 ResearchReal-World Treatment Patterns and Transfusion Burden Among Newly Diagnosed Older Adults with Acute Myeloid Leukemia
Zeidan A, Cheng W, Kamalakar R, Miller C, Bui C, Montez M, Yee T, Wu Z, Huntington S. Real-World Treatment Patterns and Transfusion Burden Among Newly Diagnosed Older Adults with Acute Myeloid Leukemia. Blood 2022, 140: 3282-3283. DOI: 10.1182/blood-2022-160002.Peer-Reviewed Original ResearchStreamline - Retrospective Cohort Study of FLT3-mutated Acute Myeloid Leukemia (AML): Real-World Treatment Patterns and Clinical Outcomes after First Relapse or Refractory (R/R) Diagnosis
Zeidan A, Gautam S, Yu R, Lan Z, Grinblatt D, ElSouda D, Spalding J, Block A, Touya M, Pandya B. Streamline - Retrospective Cohort Study of FLT3-mutated Acute Myeloid Leukemia (AML): Real-World Treatment Patterns and Clinical Outcomes after First Relapse or Refractory (R/R) Diagnosis. Blood 2022, 140: 8124-8126. DOI: 10.1182/blood-2022-166692.Peer-Reviewed Original ResearchHow Many Stratification Factors Are Reasonable and Can There be Too Many? Evaluation of Analysis Strategies in the Context of a Randomized Phase 2 Trial in Acute Myeloid Leukemia within the Myelomatch Platform
Moseley A, Freidlin B, Shallis R, Zeidan A, Sallman D, Little R, Erba H, Leblanc M, Othus M. How Many Stratification Factors Are Reasonable and Can There be Too Many? Evaluation of Analysis Strategies in the Context of a Randomized Phase 2 Trial in Acute Myeloid Leukemia within the Myelomatch Platform. Blood 2022, 140: 8932-8933. DOI: 10.1182/blood-2022-170376.Peer-Reviewed Original ResearchTP53-altered higher-risk myelodysplastic syndromes/neoplasms and acute myeloid leukemia: a distinct genetic entity with unique unmet needs
Ball S, Loghavi S, Zeidan A. TP53-altered higher-risk myelodysplastic syndromes/neoplasms and acute myeloid leukemia: a distinct genetic entity with unique unmet needs. Leukemia & Lymphoma 2022, 64: 540-550. PMID: 36323304, DOI: 10.1080/10428194.2022.2136969.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaMyelodysplastic syndromeVariant allele frequencyMyeloid leukemiaMDS/acute myeloid leukemiaIndependent poor prognostic factorBCL2 inhibitor venetoclaxPoor prognostic factorDisease-modifying therapiesIntensive chemotherapyBlast countClinical coursePrognostic factorsInvestigational agentsDisease entityClinical studiesInhibitor venetoclaxMyeloid neoplasmsResponse ratePathogenic alterationsNeoplasmsDistinct genetic entitiesLeukemiaGenetic characteristicsAllele frequenciesPoster: AML-484 First Results of a Phase II Study (STIMULUS-AML1) Investigating Sabatolimab + Azacitidine + Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (ND AML)
Zeidan A, Westermann J, Kovacsovics T, Assouline S, Schuh A, Kim H, Macias G, Sanford D, Luskin M, Stein E, Malek K, Lyu J, Stegert M, Esteve J. Poster: AML-484 First Results of a Phase II Study (STIMULUS-AML1) Investigating Sabatolimab + Azacitidine + Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (ND AML). Clinical Lymphoma Myeloma & Leukemia 2022, 22: s125. DOI: 10.1016/s2152-2650(22)00747-9.Peer-Reviewed Original ResearchPoster: AML-055 Outcomes Based on Sequential Use of Venetoclax Based Therapy and Targeted Therapy in Acute Myeloid Leukemia (AML)
Stahl M, Shallis R, Derkach A, Goldberg A, Stein A, Stein E, Marcucci G, Zeidan A, Shimony S, DeAngelo D, Stone R, Aldoss I, Ball B, Bewersdorf J. Poster: AML-055 Outcomes Based on Sequential Use of Venetoclax Based Therapy and Targeted Therapy in Acute Myeloid Leukemia (AML). Clinical Lymphoma Myeloma & Leukemia 2022, 22: s128. DOI: 10.1016/s2152-2650(22)00761-3.Peer-Reviewed Original ResearchP570: REAL-WORLD EFFICACY OUTCOMES OF VENETOCLAX PLUS AZACITIDINE VS INTENSIVE CHEMOTHERAPY FOR INDUCTION THERAPY IN ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA
Zeidan A, Pollyea D, Borate U, Vasconcelos A, Potluri R, Rotter D, Kiendrebeogo Z, Gaugler L, Bonifacio G, Prebet T, Chen C. P570: REAL-WORLD EFFICACY OUTCOMES OF VENETOCLAX PLUS AZACITIDINE VS INTENSIVE CHEMOTHERAPY FOR INDUCTION THERAPY IN ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA. HemaSphere 2022, 6: 469-470. DOI: 10.1097/01.hs9.0000845168.01159.c0.Peer-Reviewed Original ResearchP582: FIRST RESULTS OF A PHASE II STUDY (STIMULUS‐AML1) INVESTIGATING SABATOLIMAB + AZACITIDINE + VENETOCLAX IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA
Zeidan A, Westermann J, Kovacsovics T, Assouline S, Schuh A, Kim H, Macias G, Sanford D, Luskin M, Stein E, Malek K, Lyu J, Stegert M, Esteve J. P582: FIRST RESULTS OF A PHASE II STUDY (STIMULUS‐AML1) INVESTIGATING SABATOLIMAB + AZACITIDINE + VENETOCLAX IN PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA. HemaSphere 2022, 6: 481-482. DOI: 10.1097/01.hs9.0000845216.33320.a2.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
The Current Understanding of and Treatment Paradigm for Newly-Diagnosed TP53-Mutated Acute Myeloid Leukemia
Shallis R, Stahl M, Bewersdorf J, Zeidan A. The Current Understanding of and Treatment Paradigm for Newly-Diagnosed TP53-Mutated Acute Myeloid Leukemia. Hemato 2021, 2: 748-763. DOI: 10.3390/hemato2040051.Peer-Reviewed Original ResearchAcute myeloid leukemiaMyeloid leukemiaTherapy-related acute myeloid leukemiaMeasurable residual disease statusHematopoietic stem cell transplantationMedian overall survivalResidual disease statusStem cell transplantationCurrent treatment approachesIntensive chemotherapyIntensive regimensRemission rateCytogenetic riskOverall survivalWorse prognosisCell transplantationConditioning intensityTreatment paradigmTreatment approachesTP53 mutationsDisease statusBiological subsetsPatientsPrognosisLeukemiaGilteritinib vs salvage chemotherapy in FLT3-mutated acute myeloid leukemia: number needed to treat for clinical outcomes per a secondary analysis of the ADMIRAL trial
Zeidan AM, Qi CZ, Yang H, Garnham A, Shah MV, Pandya BJ. Gilteritinib vs salvage chemotherapy in FLT3-mutated acute myeloid leukemia: number needed to treat for clinical outcomes per a secondary analysis of the ADMIRAL trial. Leukemia & Lymphoma 2021, 63: 762-764. PMID: 34749571, DOI: 10.1080/10428194.2021.2001467.Peer-Reviewed Original Research