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gilteritinib

Generic: GILTERITINIB FUMARATE·Brand: XOSPATA, Xospata

gilteritinib: 12 clinical trials tracked.

gilteritinib evidence translation

What we can confirm

12 tracked trials

No verified listed developer

What it means

AI will separate confirmed drug evidence from unknown company context.

What to watch

Watch trial status, endpoints, and the next source-backed update.
BioSniper AIPage evidence connected

Prepared research question

What is verified about gilteritinib, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 6 study sponsors
Clinical Trials (12)showing 10 most recent

Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia

NCT07548710·Phase 2
Recruiting

Primary endpoint: Composite Complete Remission

Interventionalopen205 targetStarted 2026-05Completion 2028-121 site · ChinaRuijin Hospital

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

NCT07032727·Phase 2
Recruiting

Primary endpoint: Safety and adverse events (AEs)

Interventionalopen68 targetStarted 2025-09Completion 2029-061 site · United StatesM.D. Anderson Cancer Center

A Comparison Between Gilteritinib in Phase 3 Trials Versus Real-World External Comparator Cohort of Relapsed/Refractory (R/R) FLT3m+ Acute Myeloid Leukemia (AML) Patients After Hematopoietic Stem Cell Transplantation (HSCT)

Completed

Primary endpoint: Relapse Free Survival (RFS)

Observational114 enrolledStarted 2025-01Completion 2025-0718 sites · Australia, Brazil, China, Hong Kong…Astellas Pharma Singapore Pte. Ltd.

A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Treatment Trial

NCT06317649·Phase 2·MRUS
Recruiting

Primary endpoint: Rate of measured residual disease (MRD) negative complete remission (CR)

InterventionalRandomizedopen147 targetStarted 2024-09Completion 2029-0550 sites · United StatesNational Cancer Institute (NCI)

Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials

NCT05564390·Phase 2·MRUS
Recruiting

Primary endpoint: Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

Interventionalopen2,000 targetStarted 2024-06Completion 2029-0550 sites · United StatesNational Cancer Institute (NCI)

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

NCT06001788·Phase 1·KURA
Recruiting

Primary endpoint: Rate of dose limiting toxicities (DLTs) per dose level

Interventionalopen171 targetStarted 2024-02Completion 2027-0845 sites · Italy, Spain, United StatesKura Oncology, Inc.

A Collaboration Phase 2 Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia

NCT05955261·Phase 2·GHRS
Suspended

Primary endpoint: Minimal residual disease (MRD)-negativity rate

Interventionalopen70 targetStarted 2023-07Completion 2034-0310 sites · United StatesSt. Jude Children's Research Hospital

A Phase 1 Study of Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated Acute Myeloid Leukemia

NCT05024552·Phase 1·JAZZ
Recruiting

Primary endpoint: Maximum Tolerated Dose (MTD)

Interventionalopen22 targetStarted 2022-02Completion 2027-031 site · United StatesH. Lee Moffitt Cancer Center and Research Institute

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

NCT04293562·Phase 3
Recruiting

Primary endpoint: Event-free survival (EFS)

InterventionalRandomizedopen1,186 targetStarted 2020-07Completion 2029-0650 sites · United StatesChildren's Oncology Group

A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

NCT03625505·Phase 1·ABBV
Completed

Primary endpoint: Recommended Phase 2 Dose (RPTD) of Co-administered Study Drugs

Interventionalopen61 enrolledStarted 2018-10Completion 2021-0811 sites · United StatesAbbVie