2023
Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML
Pratz K, Cherry M, Altman J, Cooper B, Podoltsev N, Cruz J, Lin T, Schiller G, Jurcic J, Asch A, Wu R, Hill J, Gill S, James A, Rich E, Hasabou N, Perl A, Levis M. Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML. Journal Of Clinical Oncology 2023, 41: 4236-4246. PMID: 37379495, DOI: 10.1200/jco.22.02721.Peer-Reviewed Original ResearchConceptsPhase Ib studyMaintenance therapyConsolidation chemotherapyDose escalationFLT3 inhibitorsIb studyHigh-dose cytarabine consolidationMedian overall survival timeSingle-agent maintenance therapyComplete response rateHigher trough levelsOverall survival timeCytarabine consolidationChemotherapy regimenDose expansionAdult patientsIntensive inductionTrough levelsCount recoveryMedian timeRandomized trialsInduction cyclesSurvival timeDay 1Response rate
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