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
Phase 1 dose escalation trial of volasertib in combination with decitabine in patients with acute myeloid leukemia
Cortes J, Podoltsev N, Kantarjian H, Borthakur G, Zeidan AM, Stahl M, Taube T, Fagan N, Rajeswari S, Uy GL. Phase 1 dose escalation trial of volasertib in combination with decitabine in patients with acute myeloid leukemia. International Journal Of Hematology 2020, 113: 92-99. PMID: 32951163, DOI: 10.1007/s12185-020-02994-8.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntineoplastic Combined Chemotherapy ProtocolsCell Cycle ProteinsDecitabineDose-Response Relationship, DrugFebrile NeutropeniaFeeding and Eating DisordersFemaleGene ExpressionHumansLeukemia, Myeloid, AcuteMaleMolecular Targeted TherapyProtein Serine-Threonine KinasesProto-Oncogene ProteinsPteridinesTreatment OutcomeConceptsAcute myeloid leukemiaMyeloid leukemiaCommon treatment-emergent adverse eventsPhase 1 dose-escalation trialTreatment-emergent adverse eventsMTD of volasertibObjective response rateAdverse event profileDose-escalation trialPhase 1 trialAnti-leukemic activityPolo-like kinase 1Febrile neutropeniaEscalation trialAdverse eventsCell cycle kinase inhibitorsAML patientsEvent profilePoor prognosisResponse ratePatientsVolasertibDecitabineKinase inhibitorsNumerous cancers
2019
Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial
Garcia-Manero G, Roboz G, Walsh K, Kantarjian H, Ritchie E, Kropf P, O'Connell C, Tibes R, Lunin S, Rosenblat T, Yee K, Stock W, Griffiths E, Mace J, Podoltsev N, Berdeja J, Jabbour E, Issa JJ, Hao Y, Keer HN, Azab M, Savona MR. Guadecitabine (SGI-110) in patients with intermediate or high-risk myelodysplastic syndromes: phase 2 results from a multicentre, open-label, randomised, phase 1/2 trial. The Lancet Haematology 2019, 6: e317-e327. PMID: 31060979, PMCID: PMC9012213, DOI: 10.1016/s2352-3026(19)30029-8.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeMyelodysplastic syndromeRefractory cohortAdverse eventsRefractory diseaseHypomethylating agentEastern Cooperative Oncology Group performance statusNorth American medical centersInternational Prognostic Scoring SystemCommon grade 3Phase 2 partWorse adverse eventsOpen-label studyProportion of patientsPrognostic scoring systemOverall responseChronic myelomonocytic leukemiaNew therapeutic optionsAmerican medical centersEligible patientsFebrile neutropaeniaIntravenous decitabinePrimary endpointRefractory patientsStudy drug
2017
Guadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial
Kantarjian HM, Roboz GJ, Kropf PL, Yee KWL, O'Connell CL, Tibes R, Walsh KJ, Podoltsev NA, Griffiths EA, Jabbour E, Garcia-Manero G, Rizzieri D, Stock W, Savona MR, Rosenblat TL, Berdeja JG, Ravandi F, Rock EP, Hao Y, Azab M, Issa JJ. Guadecitabine (SGI-110) in treatment-naive patients with acute myeloid leukaemia: phase 2 results from a multicentre, randomised, phase 1/2 trial. The Lancet Oncology 2017, 18: 1317-1326. PMID: 28844816, PMCID: PMC5925750, DOI: 10.1016/s1470-2045(17)30576-4.Peer-Reviewed Original ResearchMeSH KeywordsAdultAge FactorsAgedAged, 80 and overAzacitidineDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleHumansInfusions, IntravenousKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaximum Tolerated DoseMiddle AgedNeoplasm InvasivenessNeoplasm StagingPatient SafetyPrognosisProspective StudiesRemission InductionRisk AssessmentSurvival AnalysisTreatment OutcomeConceptsAcute myeloid leukemiaComposite complete responseTreatment-naive patientsTreatment-naive acute myeloid leukaemiaAdverse eventsMyeloid leukemiaComplete responseFebrile neutropeniaIntensive chemotherapyMyelodysplastic syndromeTreatment cyclesCommon serious adverse eventsRefractory acute myeloid leukemiaPhase 2 resultsFrequent grade 3Worse adverse eventsSerious adverse eventsPhase 2 studyPhase 3 studyCohort of patientsPhase 1 studyComplete tumor responseStandard of careNumber of patientsEffective treatment schedule