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 rateZiftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1- m or KMT2A -r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007
Zeidan A, Wang E, Issa G, Erba H, Altman J, Balasubramanian S, Strickland S, Roboz G, Schiller G, McMahon C, Palmisiano N, Madanat Y, Rotta M, Nadiminti K, Wei H, Riches M, Corum D, Leoni M, Dale S, Fathi A. Ziftomenib Combined with Intensive Induction (7+3) in Newly Diagnosed NPM1- m or KMT2A -r Acute Myeloid Leukemia: Interim Phase 1a Results from KOMET-007. Blood 2024, 144: 214-214. DOI: 10.1182/blood-2024-198218.Peer-Reviewed Original ResearchDose-limiting toxicityMinimal residual diseaseAcute myeloid leukemiaMedian time to neutrophil recoveryDays to platelet recoveryMinimal residual disease negativityDecreased neutrophil countKMT2A-rDecreased platelet countNPM1 mutationsAdverse eventsCRC ratesDose levelsNeutrophil recoveryData cutoffQTc prolongationPlatelet recoveryPlatelet countMyeloid leukemiaNeutrophil countDifferentiation syndromeClinical activityCycle 1 day 8Persistent acute myeloid leukemiaStandard dose of cytarabine
2022
Clinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib
Perl AE, Hosono N, Montesinos P, Podoltsev N, Martinelli G, Panoskaltsis N, Recher C, Smith CC, Levis MJ, Strickland S, Röllig C, Groß-Langenhoff M, Chou WC, Lee JH, Yokoyama H, Hasabou N, Lu Q, Tiu RV, Altman JK. Clinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib. Blood Cancer Journal 2022, 12: 84. PMID: 35637252, PMCID: PMC9151663, DOI: 10.1038/s41408-022-00677-7.Peer-Reviewed Original ResearchConceptsAcute myeloid leukemiaFLT3-TKIRefractory FLT3TKI exposureSalvage chemotherapyClinical outcomesMyeloid leukemiaR AMLLonger median overall survivalComposite complete remissionHigher CRCS ratesMedian overall survivalTyrosine kinase inhibitor midostaurinKinase inhibitor midostaurinPotential clinical impactADMIRAL trialCRC ratesGilteritinib armPrior sorafenibComplete remissionRemission durationOverall survivalTKI therapyTKI useSurvival outcomesGilteritinib 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
2020
Gilteritinib Remains Clinically Active in Relapsed/Refractory FLT3 Mutated AML Previously Treated with FLT3 inhibitors
Numan Y, Rahman Z, Grenet J, Boisclair S, Bewersdorf J, Barth D, Zeidan A, Yilmaz M, Dinner S, Deutsch Y, Frankfurt O, Litzow M, Al-Kali A, Foran J, Sproat L, Jovanovic B, Daver N, Perl A, Altman J. Gilteritinib Remains Clinically Active in Relapsed/Refractory FLT3 Mutated AML Previously Treated with FLT3 inhibitors. Blood 2020, 136: 5-7. DOI: 10.1182/blood-2020-137251.Peer-Reviewed Original ResearchStem cell transplantMedian survivalFLT3 mutationsBristol-Myers SquibbDaiichi SankyoBoehringer IngelheimCRC ratesLymphoma SocietyCombination therapyPolymerase chain reactionFLT3-ITDSingle agentDrug resistanceAdvisory CommitteeBone marrow flow cytometryComposite complete remissionFLT3-D835 mutationsHigher CRCS ratesNon-transplanted patientsPoor median survivalKaplan-Meier curvesMulti-institutional analysisLog-rank testBayer HealthCare PharmaceuticalsMAPK pathwayRisk of Metachronous Colorectal Neoplasm after a Segmental Colectomy in Lynch Syndrome Patients According to Mismatch Repair Gene Status
Quezada-Diaz FF, Hameed I, von Mueffling A, Salo-Mullen EE, Catalano A, Smith JJ, Weiser MR, Garcia-Aguilar J, Stadler ZK, Guillem JG. Risk of Metachronous Colorectal Neoplasm after a Segmental Colectomy in Lynch Syndrome Patients According to Mismatch Repair Gene Status. Journal Of The American College Of Surgeons 2020, 230: 669-675. PMID: 32007537, PMCID: PMC7104918, DOI: 10.1016/j.jamcollsurg.2020.01.005.Peer-Reviewed Original ResearchConceptsLP/P variantsMetachronous colorectal cancerColorectal cancerTotal colectomySegmental resectionSegmental colectomyMMR genesLS patientsLynch syndromeMetachronous colorectal neoplasmsMismatch repair gene statusPrimary end pointRetrospective cohort studyMMR germline mutationsLynch syndrome patientsQuality of lifeMismatch repair genesCRC overallCRC ratesEarly colectomyIndex resectionMedian followMSH2 carriersCRC incidenceCohort study
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
2018
Updated 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. Updated 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 2018, 132: 564. DOI: 10.1182/blood-2018-99-110975.Peer-Reviewed Original ResearchAcute myeloid leukemiaClinical trial workSingle-agent maintenance therapyDose-expansion cohortsSafety/tolerabilityFMS-like tyrosine kinase 3Phase 1 studyMaintenance therapyAdverse eventsCRC ratesExpansion doseAstellas PharmaFebrile neutropeniaIntensive chemotherapyDay cohortDose escalationDay 1Serious drug-related adverse eventsDrug-related adverse eventsExperienced dose-limiting toxicityHigh-dose cytarabine consolidationMedian disease-free survivalRefractory acute myeloid leukemiaWhite blood cell countAdvisory Committee
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
2014
Comparison of colorectal cancer screening and diagnoses in HIV-positive and HIV-negative veterans
Guest JL, Rentsch CT, Rimland D. Comparison of colorectal cancer screening and diagnoses in HIV-positive and HIV-negative veterans. AIDS Care 2014, 26: 1490-1493. PMID: 25008192, DOI: 10.1080/09540121.2014.933768.Peer-Reviewed Original ResearchConceptsFecal occult blood testingHIV-positive patientsColorectal cancerYounger ageAtlanta VA Medical CenterHIV-negative veteransOccult blood testingHIV-negative controlsHIV-positive casesColorectal cancer screeningPercent of casesVA Medical CenterYears of ageCRC ratesCRC incidenceHIV statusBlood testingCancer screeningMedical CenterHigh incidenceScreening typeAverage ageHIVPatientsColon polyps
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