Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia
Montesinos P, Cheong J, Daver N, Fathi A, Levis M, Luger S, Miyamoto T, Oliva E, Perl A, Récher C, Schlenk R, Wang J, Zeidan A, Liu L, Duong Y, Imadalou K, Alexis K, Nahar A, Burns K, Erba H. Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia. Blood 2024, 144: 1504.3-1504.3. DOI: 10.1182/blood-2024-205101.Peer-Reviewed Original ResearchFMS-like tyrosine kinase 3Acute myeloid leukemiaRelapse-free survivalEvent-free survivalArm AOverall survivalEligible ptsFLT3-ITDMonotherapy maintenanceAllo-HSCTDouble-blindFLT3 mutationsArm CMyeloid leukemiaAssociated with significantly prolonged overall survivalFLT3 activationFms-like tyrosine kinase 3 ligandFMS-like tyrosine kinase 3-internal tandem duplicationAllogeneic hematopoietic stem cell transplantationFms-like tyrosine kinase 3-mutatedRelapsed/refractory acute myeloid leukemiaBone marrow blast countFms-like tyrosine kinase 3 expressionCases of acute myeloid leukemiaHematopoietic stem cell transplantationA first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.
Weiss D, Dinardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Carraway H, Frankel S, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A first-in-human, phase 1, dose escalation study of SGR-2921 as monotherapy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome. Journal Of Clinical Oncology 2024, 42: tps6590-tps6590. DOI: 10.1200/jco.2024.42.16_suppl.tps6590.Peer-Reviewed Original ResearchEastern Cooperative Oncology GroupCell line-derived xenograftsDose-escalation studyMaximum tolerated dosePatient-derived xenograftsHigh riskEscalation studyTreatment armsEffects of CYP3A4 inhibitionRecommended phase 2 doseRelapsed/refractory acute myeloid leukemiaPhase 2 doseAccelerated titration designMinichromosome maintenance protein 2Preliminary antitumor activityCooperative Oncology GroupFirst-in-humanAcute myeloid leukemiaGrade 2 eventsTreated patient populationTolerated dose levelsAML cell linesAnti-tumor activityInhibition of Cdc7Cancer cell death