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Gilteritinib Clinical Trials

18 actively recruiting trials across 8 locations

No change since May 2026

Also known as: ASP 2215, ASP-2215, ASP2215, Xospata, Xospata Pill

Pipeline

Phase 1: 6Phase 2: 6Phase 3: 1Phase 1/2: 4

Top Sponsors

  • M.D. Anderson Cancer Center6
  • National Cancer Institute (NCI)2
  • University of Michigan Rogel Cancer Center1
  • Uma Borate1
  • The First Affiliated Hospital of Soochow University1

Indications

  • Cancer18
  • Acute Myeloid Leukemia8
  • Refractory Acute Myeloid Leukemia4
  • Recurrent Acute Myeloid Leukemia4
  • Myelodysplastic Syndrome3

Houston, Texas6 trials

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

MD Anderson Cancer Center

Phase 1/2
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

M D Anderson Cancer Center

Phase 1/2
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

M D Anderson Cancer Center

Phase 1/2
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia

M D Anderson Cancer Center

Phase 2
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission

M D Anderson Cancer Center

Phase 1
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations

MD Anderson Cancer Center

Phase 2

Other4 trials

Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
Phase 2
MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
Phase 3
MRD-positive AML Clinical Study
N/A
Study of SA+X in the Treatment of Newly Diagnosed AML
Phase 2

Birmingham, Alabama2 trials

MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)

University of Alabama at Birmingham Cancer Center

Phase 2
Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)

University of Alabama at Birmingham Cancer Center

Phase 2

Gilbert, Arizona1 trial

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

Banner MD Anderson Cancer Center

Phase 1

Los Angeles, California1 trial

Gilteritinib for the Treatment of ALK NSCLC

Cedars-Sinai Medical Center

Phase 1

Newport Beach, California1 trial

A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)

Hoag Family Cancer Center

Phase 1/2

Orange, California1 trial

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

University of California - Irvine

Phase 1

Basking Ridge, New Jersey1 trial

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

Memorial Sloan Kettering Basking Ridge

Phase 1

Chapel Hill, North Carolina1 trial

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

UNC Hospitals, University of North Carolina at Chapel Hill

Phase 1

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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