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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