Table 1.
Clinical trials of gilteritinib 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 |
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