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Table 1 Clinical trials of gilteritinib for acute myeloid leukemia

From: Gilteritinib: a novel FLT3 inhibitor for acute myeloid leukemia

No. AML status therapy Phase NCT Trial Status
1 R/R AML Gilteritinib Phase 1 02181660 Completed
2 R/R AML Gilteritinib Phase 1/2 02014558 Completed
3 Previously Untreated AML with FLT3 Mutation Gilteritinib Phase 1/2 03013998 Recruiting
4 Advanced Solid Tumors and AML Gilteritinib Phase 1/2 02561455 Enrolling by invitation
5 R/R AML with FLT3 Mutation or AML with FLT3 Mutation in CR with MRD Gilteritinib NA 03070093 Available
6 R/R AML with FLT3 Mutation or AML with FLT3 Mutation in CR with MRD Gilteritinib NA 03409081 No longer available
7 Pediatric R/R AML with FLT3 Mutation or AML with FLT3 Mutation in CR with MRD Gilteritinib NA 03315299 No longer available
8 R/R AML Gilteritinib + Venetoclax Phase 1 03625505 Recruiting
9 Newly Diagnosed AML Gilteritinib + Cytarabine + Idarubicin Phase 1 02310321 Active, not recruiting
10 Newly Diagnosed AML Gilteritinib + Cytarabine + Idarubicin or Gilteritinib + Cytarabine + Daunorubicin Phase 1 02236013 Recruiting
11 R/R AML with FLT3 Mutation Gilteritinib + Atezolizumab Phase 1/2 03730012 Recruiting
12 AML with FLT3/ITD Mutation in CR1 Gilteritinib vs Placebo Phase 2 02927262 Active, not recruiting
13 Untreated AML with FLT3 Mutation Gilteritinib + Daunorubicin + Cytarabine vs Midostaurin + Daunorubicin + Cytarabine Phase 2 03836209 Not yet recruiting
14 Newly Diagnosed AML With FLT3 Mutation Gilteritinib vs Gilteritinib + Azacitidine vs Azacitidine Phase 2/3 02752035 Recruiting
15 AML With FLT3/ITD Mutation in CR1 undergoing allo-HSCT Gilteritinib vs Placebo Phase 3 02997202 Recruiting
16 R/R AML with FLT3 Mutation Gilteritinib vs Salvage Chemotherapy Phase 3 03182244 Recruiting
17 R/R AML with FLT3 Mutation Gilteritinib vs Salvage Chemotherapy Phase 3 02421939 Active, not recruiting
18 Newly Diagnosed AML or MDS-EB2 with FLT3 mutation Gilteritinib vs Midostaurin in Combination With chemotherapy Phase 3 04027309 Not yet recruiting
  1. Abbreviations: R/R, Relapsed or Refractory; FLT3, FMS-like Tyrosine Kinase 3; ITD, Internal Tandem Duplication; CR, Complete Remission; MRD, Minimal Residual Disease; MDS-EB2, Myelodysplastic Syndromes with Excess Blasts-2; NA, Not Available; allo-HSCT, allogeneic Hematopoietic Stem Cell Transplant