2024
Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory NPM1 -m or KMT2A -r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Fathi A, Issa G, Wang E, Erba H, Altman J, Balasubramanian S, Roboz G, Schiller G, McMahon C, Palmisiano N, Juckett M, Madanat Y, Rotta M, Pratz K, Yaghmour G, Nadiminti K, Wei H, Riches M, Corum D, Leoni M, Dale S, Zeidan A. Ziftomenib Combined with Venetoclax/Azacitidine in Relapsed/Refractory NPM1 -m or KMT2A -r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007. Blood 2024, 144: 2880-2880. DOI: 10.1182/blood-2024-199170.Peer-Reviewed Original ResearchAcute myeloid leukemiaDecreased neutrophil countDecreased platelet countNPM1 mutationsKMT2A-rAdverse eventsCRC ratesClinical activityR/R patientsData cutoffQTc prolongationPlatelet countMyeloid leukemiaNucleophosmin 1Neutrophil countDifferentiation syndromeComposite complete remission rateCycle 1 day 8R/R acute myeloid leukemiaTreatment-emergent adverse eventsDose of venetoclaxInhibitor-naive patientsDose-escalation cohortsDose-expansion phaseComplete remission rateComparative Analysis of Outcomes with HMA Plus Venetoclax Vs Intensive Chemotherapy in AML Patients Harboring Very-High Risk Cytogenetics
Aguirre L, Bewersdorf J, Liu Y, Shallis R, Boussi L, Zucenka A, Garciaz S, Bystrom R, DeAngelo D, Stone R, Luskin M, Garcia J, Winer E, Ling K, Chen E, Wadleigh M, Stein E, Goldberg A, Zeidan A, Shimony S, Stahl M. Comparative Analysis of Outcomes with HMA Plus Venetoclax Vs Intensive Chemotherapy in AML Patients Harboring Very-High Risk Cytogenetics. Blood 2024, 144: 4267-4267. DOI: 10.1182/blood-2024-202744.Peer-Reviewed Original ResearchMorphologic leukemia-free stateComposite complete remissionTreated with ICIntensive chemotherapyMonosomal karyotypeComplex karyotypeProgressive diseaseSurvival outcomesTreatment strategiesAllogeneic hematopoietic stem cell transplantationComposite complete remission rateTreated with intensive chemotherapyHematopoietic stem cell transplantationComparative analysis of outcomesDismal survival outcomesConventional cytotoxic chemotherapyAggressive disease biologyMulticenter retrospective cohortStem cell transplantationAnalyze survival outcomesKaplan-Meier methodLog-rank testAnalysis of outcomesCK-AMLCPX-351
2022
Gilteritinib clinical activity in relapsed/refractory FLT3 mutated acute myeloid leukemia previously treated with FLT3 inhibitors
Numan Y, Rahman Z, Grenet J, Boisclair S, Bewersdorf JP, Collins C, Barth D, Fraga M, Bixby DL, Zeidan AM, Yilmaz M, Desai P, Mannis G, Deutsch YE, Abaza Y, Dinner S, Frankfurt O, Litzow M, Al‐Kali A, Foran JM, Sproat LZ, Jovanovic B, Daver N, Perl AE, Altman JK. Gilteritinib clinical activity in relapsed/refractory FLT3 mutated acute myeloid leukemia previously treated with FLT3 inhibitors. American Journal Of Hematology 2022, 97: 322-328. PMID: 34981560, DOI: 10.1002/ajh.26447.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaMyeloid leukemiaRelapsed/Refractory Acute Myeloid LeukemiaComposite complete remission rateRefractory acute myeloid leukemiaLower median overall survivalComplete remission rateMedian overall survivalStem cell transplantCRC ratesLower CRCRefractory FLT3Median survivalRemission rateIntensive inductionOverall survivalCell transplantCombination therapyFLT3 inhibitorsFLT3 mutationsClinical activityUS CentersRetrospective analysisADMIRAL studyMitogen-activated protein kinase pathway
2021
Venetoclax for the treatment of elderly or chemotherapy-ineligible patients with acute myeloid leukemia: a step in the right direction or a game changer?
Agarwal S, Kowalski A, Schiffer M, Zhao J, Bewersdorf JP, Zeidan AM. Venetoclax for the treatment of elderly or chemotherapy-ineligible patients with acute myeloid leukemia: a step in the right direction or a game changer? Expert Review Of Hematology 2021, 14: 199-210. PMID: 33459064, DOI: 10.1080/17474086.2021.1876559.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsConceptsAcute myeloid leukemiaIntensive chemotherapyAML patientsTherapeutic optionsMyeloid leukemiaComposite complete remission rateOral BCL-2 inhibitorChemotherapy-ineligible patientsNovel triplet combinationLow-dose cytarabineComplete remission rateDurability of responseAttractive therapeutic optionPubMed/MEDLINERemission rateElderly patientsTreatment landscapeAML treatmentPoor prognosisAggressive malignancyCombination therapyBcl-2 inhibitorsMechanisms of resistanceClinical dataToxicity profile
2019
PS1036 UPDATED RESULTS FROM A PHASE 1 STUDY OF GILTERITINIB IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED AML
Pratz K, Cherry M, Altman J, Cooper B, Cruz J, Jurcic J, Levis M, Lin T, Perl A, Podoltsev N, Schiller G, Liu C, Bahceci E. PS1036 UPDATED RESULTS FROM A PHASE 1 STUDY OF GILTERITINIB IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED AML. HemaSphere 2019, 3: 468. DOI: 10.1097/01.hs9.0000562440.81745.10.Peer-Reviewed Original ResearchPhase 1 studyMaintenance therapyAdverse eventsConsolidation chemotherapyExpansion doseFebrile neutropeniaSerious drug-related adverse eventsComposite complete remission rateSingle-agent maintenance therapyDrug-related adverse eventsWhite blood cell countMedian overall survivalSafety/tolerabilityComplete remission rateFront-line chemotherapyDose-limiting toxicitySmall intestinal obstructionBlood cell countCycles of inductionHigh response rateCRC ratesIdarubicin inductionDose expansionIntestinal obstructionOverall survival
2017
Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML)
Pratz K, Cherry M, Altman J, Cooper B, Cruz J, Jurcic J, Levis M, Lin T, Perl A, Podoltsev N, Schiller G, Liu C, Bahceci E. Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML). Blood 2017, 130: 722. DOI: 10.1182/blood.v130.suppl_1.722.722.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAcute myeloid leukemiaEvent-free survivalDisease-free survivalMedian event-free survivalMedian overall survivalFMS-like tyrosine kinase 3Phase 1 studyOverall survivalCRC ratesExpansion doseFebrile neutropeniaIntensive chemotherapyMaintenance therapyDose escalationDaiichi SankyoRefractory (R/R) AMLSerious drug-related treatment-emergent adverse eventsDrug-related treatment-emergent adverse eventsDay 1Response rateComposite complete remission rateHigh-dose cytarabine consolidationMedian disease-free survivalSafety/tolerability profile
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