Clinical Trials

MyeloidOther hematologic neoplasm

2,000 enrolled

Myelodysplastic Syndromes, Myeloproliferative Disorders, Leukemia, Myeloid, Acute

NCT06317649 2026-03-18

Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

147 enrolled

Leukemia, Myeloid, Acute

NCT06222580 2026-03-13

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

30 enrolled

Phase 3 Not yet recruiting

Leukemia, Myeloid, Acute

NCT07463651 2026-03-11

TROPHY-15

594 enrolled

Leukemia, Myeloid, Acute

NCT05756777 2026-03-05

A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)

36 enrolled

Phase 1/2 Active not recruiting

Leukemia, Myeloid, Acute

NCT05520567 2026-03-04

A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia

70 enrolled

Neoplasms, Leukemia, Myeloid, Acute

NCT07140016 2026-03-04

A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

Phase 3 Not yet recruiting

40 enrolled

Thoracic

Carcinoma, Non-Small-Cell Lung

NCT07407140 2026-03-02

VAG-3+7-G

300 enrolled

Leukemia, Myeloid, Acute

NCT04293562 2026-02-24

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

Phase 3 Recruiting

1,186 enrolled

Phase 3 Active not recruiting

Leukemia, Myeloid, Acute

NCT03182244 2026-02-06

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

276 enrolled 41 charts

Leukemia, Myeloid, Acute

NCT05010772 2026-01-14

Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

125 enrolled

Leukemia, Myeloid, Acute

NCT04240002 2026-01-05

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)

Phase 1/2 Terminated

9 enrolled 21 charts

Leukemia, Myeloid, Acute

NCT07032727 2025-12-15

Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

68 enrolled

Targeted Therapy

NCT05955261 2025-12-09

A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

Phase 2 Suspended

70 enrolled

MyeloidOther hematologic neoplasm

Leukemia, Myeloid, Acute

NCT04140487 2025-12-05

Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm

Phase 1/2 Recruiting

97 enrolled

Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Myelodysplastic-Myeloproliferative Diseases

NCT02421939 2025-12-04

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

Phase 3 Completed

371 enrolled 36 charts 2 FDA

Leukemia, Myeloid, Acute

NCT06001788 2025-12-03

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

171 enrolled

Leukemia, Leukemia, Myeloid, Neoplasms by Histologic Type, Leukemia, Myeloid, Acute, Hematologic Neoplasms

NCT06235801 2025-11-19

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

Phase 1/2 Recruiting

20 enrolled

Leukemia, Myeloid

NCT02752035 2025-09-12

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 Chemotherapy

Phase 3 Completed

183 enrolled 30 charts

Leukemia, Myeloid, Acute

NCT06734585 2025-09-12

Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant

Completed

114 enrolled

Recurrence, Leukemia, Myeloid, Acute

NCT02310321 2025-09-02

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.

Phase 1/2 Completed

97 enrolled 30 charts

Leukemia, Myeloid, Acute

NCT07131059 2025-08-20

MRD-positive AML Clinical Study

Phase NA Recruiting

120 enrolled

Phase NA Not yet recruiting

Leukemia, Myeloid, Acute, Neoplasm, Residual

NCT06992934 2025-08-03

TARGETALLO

10 enrolled

Phase 2 Active not recruiting

Hematologic Neoplasms

NCT03836209 2025-06-15

Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

181 enrolled 18 charts

Leukemia, Myeloid, Acute

NCT04691648 2025-05-31

A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation

Completed

33 enrolled

Recurrence, Leukemia, Myeloid, Acute

NCT06696183 2025-05-29

SEQUENCE

60 enrolled

LymphoidOther hematologic neoplasm

Leukemia, Myeloid, Acute

NCT04988555 2025-04-02

A Study of DSP-5336 in Relapsed/Refractory AML/ ALL With or Without MLL Rearrangement or NPM1 Mutation

Phase 1/2 Recruiting

362 enrolled

Recurrence, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma

NCT06022003 2025-03-24

OGILAR

33 enrolled

Phase 2 Not yet recruiting

Leukemia, Myeloid, Acute

NCT06667973 2025-03-12

Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia

80 enrolled

Disease, Leukemia, Myeloid, Acute

NCT02997202 2025-01-17

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)

Phase 3 Completed

356 enrolled 22 charts

Leukemia, Myeloid, Acute

NCT02014558 2024-12-03

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1/2 Completed

265 enrolled 80 charts

Leukemia, Myeloid, Acute

NCT03730012 2024-11-29

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)

Phase 1/2 Completed

11 enrolled 18 charts

Leukemia, Myeloid, Acute

NCT02495233 2024-11-27

A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Phase 1/2 Terminated

10 enrolled 18 charts

Thoracic

Carcinoma, Non-Small-Cell Lung

NCT02927262 2024-11-26

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 Remission

Phase 2 Completed

98 enrolled 17 charts

Leukemia, Myeloid, Acute

NCT02181660 2024-11-06

Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

24 enrolled

Leukemia, Myeloid, Acute

NCT02236013 2024-11-05

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

80 enrolled

Leukemia, Myeloid, Acute

NCT02456883 2024-11-05

Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors

6 enrolled

Other solid neoplasm

Advanced Solid Tumors

NCT06221683 2024-08-22

GMCAII

500 enrolled

Leukemia, Myeloid, Acute

NCT05028751 2024-08-07

A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)

Phase 1/2 Terminated

24 enrolled 19 charts

Leukemia, Myeloid, Acute

NCT04336982 2024-05-31

A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

Phase 1 Terminated

22 enrolled

Leukemia, Leukemia, Myeloid, Acute

NCT05330377 2023-04-25

GM-CLAG in Relapsed/Refractory FLT3-mutated AML

Phase 1 Withdrawn

Recurrence, Leukemia, Myeloid, Acute

NCT05791890 2023-03-30

GilteRInf

Unknown

78 enrolled

Infections, Leukemia, Myeloid, Acute

NCT05312112 2023-03-02

Real World Outcomes Using Novel Agents for AML in the UK

Unknown

1,000 enrolled

Leukemia, Myeloid, Acute

NCT05279859 2022-06-15

HERKULES-4

Phase 1/2 Withdrawn

Recurrence, Leukemia, Myeloid, Acute

NCT04655391 2022-06-09

Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation

Phase 1 Withdrawn

Leukemia, Myeloid, Acute

NCT03625505 2021-09-14

A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

61 enrolled

Neoplasms, Recurrence, Leukemia, Myeloid, Acute

NCT03070093 2021-04-20

Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

Approved for marketing

Leukemia, Myeloid, Acute

NCT03409081 2018-09-13

Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)

No longer available