Gilteritinib: all 43 studies that test it

Page 1 of 1. Open to participants first (21), then studies with results posted, then the rest; newest registration first within each.

• MRD-guided Maintenance Post-HCT: Gilteritini vs SorafenibRecruitingNCT07463651Phase 3
• FLT3-ITD Targeted Therapy in Fit AML PatientsNot yet recruitingNCT07425808Phase 2/3
• VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AMLNot yet recruitingNCT07407140Phase 3
• A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)RecruitingNCT07140016Phase 1
• MRD-positive AML Clinical StudyRecruitingNCT07131059Not applicable
• Immunological Impact of a Post Cell Therapy Treatment With FLT3 InhibitorsNot yet recruitingNCT06992934Not applicable
• Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive TreatmentRecruitingNCT06696183Phase 2
• Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid LeukemiaNot yet recruitingNCT06667973Phase 2
• The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 MutationRecruitingNCT06561880Phase 1/2
• Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid LeukemiaRecruitingNCT06265545Not applicable
• A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid LeukemiaRecruitingNCT06235801Phase 1/2
• Gilteritinib for the Treatment of ALK NSCLCRecruitingNCT06225427Phase 1
• SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 MutationRecruitingNCT06222580Phase 1
• Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid LeukemiaRecruitingNCT06022003Phase 2
• MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)RecruitingNCT05564390Phase 2
• Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AMLRecruitingNCT05024552Phase 1
• Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in RemissionRecruitingNCT05010772Phase 1
• ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic SyndromeRecruitingNCT05010122Phase 1/2
• A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 MutationsRecruitingNCT04293562Phase 3
• Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative NeoplasmRecruitingNCT04140487Phase 1/2
• Study of Biomarker-Based Treatment of Acute Myeloid LeukemiaRecruitingNCT03013998Phase 2/3
• A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)TerminatedNCT05028751Phase 1/2Results posted
• A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)TerminatedNCT04240002Phase 1/2Results posted
• Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid LeukemiaCompletedNCT03836209Phase 2Results posted
• A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)CompletedNCT03730012Phase 1/2Results posted
• A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) MutationCompletedNCT03182244Phase 3Results posted
• A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)CompletedNCT02997202Phase 3Results posted
• A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete RemissionCompletedNCT02927262Phase 2Results posted
• A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard ChemotherapyCompletedNCT02752035Phase 3Results posted
• Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 TrialCompletedNCT02561455Phase 1/2Results posted
• A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) MutationCompletedNCT02421939Phase 3Results posted
• A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.CompletedNCT02310321Phase 1/2Results posted
• Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)Active, not recruitingNCT05546580Phase 1
• A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid LeukemiaActive, not recruitingNCT05520567Phase 1/2
• GM-CLAG in Relapsed/Refractory FLT3-mutated AMLWithdrawnNCT05330377Phase 1
• A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal FunctionCompletedNCT04699877Phase 1
• A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid LeukemiaTerminatedNCT04336982Phase 1
• A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive ChemotherapyActive, not recruitingNCT04027309Phase 3
• A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy SubjectsCompletedNCT03964038Phase 1
• A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid LeukemiaCompletedNCT03625505Phase 1
• A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215CompletedNCT02571816Phase 1
• Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid TumorsCompletedNCT02456883Phase 1
• Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid LeukemiaCompletedNCT02181660Phase 1

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