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Table 1 A selection of active studies evaluating FLT3 inhibitors in AML

From: Molecular targeting in acute myeloid leukemia

Protocol title NCT identifier
Agent: sorafenib
 Phase I/II study of combination of sorafenib, vorinostat, and bortezomib for the treatment of acute myeloid leukemia with complex- or poor-risk (monosomy 5/7) cytogenetics or FLT3–ITD positive genotype (Sponsors: Millennium Pharmaceuticals, Inc., Bayer, and Merck Sharp & Dohme Corp.) NCT01534260
 A pilot study of sorafenib in patients with acute myeloid leukemia as peri-transplant remission maintenance (Sponsor: National Cancer Institute) NCT01578109
 Phase I study of the combination of bortezomib and sorafenib followed by decitabine in patients with acute myeloid leukemia (Sponsor: National Cancer Institute) NCT01861314
Agent: midostaurin
 An open-labeled, multi-center, expanded treatment protocol (ETP) of midostaurin (PKC412) in patients 18 years of age or older with newly-diagnosed FLT3-mutated acute myeloid leukemia (AML) who are eligible for standard induction and consolidation chemotherapy (Sponsor: Novartis Pharmaceuticals) NCT03114228
 A phase II, randomized trial of standard of care, with or without midostaurin to prevent relapse following allogeneic hematopoietic stem cell transplantation in patients with FLT3–ITD mutated acute myeloid leukemia (Sponsor: Novartis Pharmaceuticals) NCT01883362
 A randomized phase II/III trial of “Novel Therapeutics” versus azacitidine in newly diagnosed patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), age 60 or older LEAP: Intergroup less-intense AML platform trial (Sponsor: National Cancer Institute) NCT03092674
Agent: quizartinib
 A phase 3 open-label randomized study of quizartinib (AC220) monotherapy versus salvage chemotherapy in subjects with tyrosine kinase 3—internal tandem duplication (FLT3–ITD) positive acute myeloid leukemia (AML) refractory to or relapsed after first-line treatment with or without hematopoietic stem cell transplantation (HSCT) consolidation (Sponsor: Daiichi Sankyo Inc.) NCT02039726
 A phase 3, double-blind, placebo-controlled study of quizartinib (AC220) administered in combination with induction and consolidation chemotherapy, and administered as maintenance therapy in subjects 18–75 years old with newly diagnosed FLT3–ITD (+) acute myeloid leukemia (Sponsor: Daiichi Sankyo Inc.) NCT02668653
 A phase II single-arm open-labeled study evaluating combination of quizartinib and omacetaxine mepesuccinate (QUIZOM) in newly diagnosed or relapsed/refractory AML carrying FLT3–ITD (Sponsor: The University of Hong Kong) NCT03135054
Agent: gilteritinib
 A multi-center, randomized, double-blind, placebo-controlled phase III trial of the FLT3 inhibitor gilteritinib administered as maintenance therapy following allogeneic transplant for patients with FLT3/ITD AML (Sponsor: Astellas Pharma Global Development, Inc.) NCT02997202
 A phase 3 multicenter, randomized, double-blind, placebo-controlled trial of the FLT3 inhibitor gilteritinib (ASP2215) administered as maintenance therapy following induction/consolidation therapy for subjects with FLT3/ITD AML in first complete remission (Sponsor: Astellas Pharma Global Development, Inc.) NCT02927262
 A phase 2/3 multicenter, open-label, 3-arm, 2-stage randomized study of ASP2215 (gilteritinib), combination of ASP2215 plus azacitidine and azacitidine alone in the treatment of newly diagnosed acute myeloid leukemia with FLT3 mutation in patients not eligible for intensive induction chemotherapy (Sponsor: Astellas Pharma Global Development, Inc.) NCT02752035
Agent: crenolanib
 Pilot study of crenolanib combined with standard salvage chemotherapy in subjects with relapsed/refractory acute myeloid leukemia (Sponsor: Arog Pharmaceuticals, Inc.) NCT02626338
 A phase II study of crenolanib besylate maintenance following allogeneic stem cell transplantation in patients with FLT3-positive acute myeloid leukemia (Sponsor: Arog Pharmaceuticals, Inc.) NCT02400255
 Phase I–II study of crenolanib combined with standard salvage chemotherapy, and crenolanib combined With 5-azacitidine in acute myeloid leukemia patients with FLT3 activating mutations (Sponsor: Arog Pharmaceuticals, Inc.) NCT02400281
Agent: others
 First in man study to evaluate the safety, tolerability and preliminary efficacy of the Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia patients with minimal residual disease (Sponsor: University Hospital Tuebingen) NCT02789254
 Phase I open-label, sequential dose escalation study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SKLB1028 when administered daily to patients with relapsed or refractory acute myeloid leukemia (Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd) NCT02859948
 A first-in-human phase 1/2a study to assess the safety, tolerability, efficacy, and pharmacokinetics of FF-10101-01 in subjects with relapsed or refractory acute myeloid leukemia (Sponsor: Fujifilm Pharmaceuticals U.S.A., Inc.) NCT03194685