Gilteritinib

Generic Name: Gilteritinib

Brand Names: Xospata

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₄₄N_₈O_₃

CAS Number: 1254053-43-4

Unique Ingredient Identifier: 66D92MGC8M

Background: Gilteritinib, also known as ASP2215, is a small molecule part of the FLT3 tyrosine kinase inhibitors that presented a greater selectivity and potency when compared with other agents from this group. It is a pyrazinecarboxamide derivative that showed high selectivity to FLT3 preventing the c-Kit -driven myelosuppression observed in other therapies. Gilteritin...

Indication: Gilteritinib is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation detected by an FDA-approved test. This indication was expanded for a companion diagnostic to include use with gilteritinib such as the LeukoStrat CDx FLT3 Mutation Assay.
...

Associated Conditions: Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

Associated Therapies: -

Clinical Trials

GilteRInf 2022 Study (Gilteritinib Related Infections)

Active, not recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib

First Posted Date: 2023-03-30

Last Posted Date: 2023-03-30

Lead Sponsor: University of Rome Tor Vergata

Target Recruit Count: 78

Registration Number: NCT05791890

Locations: 🇮🇹
Maria Ilaria Del Principe, Roma, RM, Italy

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

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Gilteritinib
Drug: Ivosidenib
Drug: Enasidenib

First Posted Date: 2023-03-06

Last Posted Date: 2024-11-12

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 36

Registration Number: NCT05756777

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 4 locations

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

Phase 2

Recruiting

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Procedure: Biospecimen Collection
Drug: Azacitidine
Procedure: Mutation Carrier Screening
Other: Best Practice
Procedure: Bone Marrow Aspiration
Procedure: Biopsy
Drug: Decitabine and Cedazuridine
Procedure: Bone Marrow Biopsy
Drug: Cytarabine
Drug: Enasidenib
Drug: Gilteritinib
Drug: Daunorubicin Hydrochloride
Procedure: Echocardiography
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Drug: Venetoclax
Procedure: Multigated Acquisition Scan

First Posted Date: 2022-10-03

Last Posted Date: 2024-12-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2000

Registration Number: NCT05564390

Locations: 🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸
Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States
🇺🇸
Marshfield Medical Center - Weston, Weston, Wisconsin, United States

and more 184 locations

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

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)
FLT3-mutated Acute Myeloid Leukemia

Interventions: Drug: Gilteritinib
Drug: Venetoclax
Drug: Azacitidine

First Posted Date: 2022-08-30

Last Posted Date: 2024-12-17

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 70

Registration Number: NCT05520567

Locations: 🇺🇸
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 16 locations

Real World Outcomes Using Novel Agents for AML in the UK

Recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Venetoclax
Drug: Gilteritinib

First Posted Date: 2022-04-05

Last Posted Date: 2023-03-02

Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Target Recruit Count: 1000

Registration Number: NCT05312112

Locations: 🇬🇧
Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom

A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies

Phase 1

Withdrawn

Conditions: Acute Myeloid Leukemia

Interventions: Drug: ERAS-007
Drug: ERAS-601
Drug: Gilteritinib

First Posted Date: 2022-03-15

Last Posted Date: 2022-06-15

Lead Sponsor: Erasca, Inc.

Registration Number: NCT05279859

Locations: 🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸
Texas Oncology, Dallas, Texas, United States
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

and more 1 locations

Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML

Phase 3

Active, not recruiting

Conditions: AML, Adult
Chemotherapy Effect

Interventions: Drug: Venetoclax
Drug: Cytarabine
Drug: Decitabine for Injection
Drug: Idarubicin
Drug: Gilteritinib

First Posted Date: 2022-01-05

Last Posted Date: 2024-10-03

Lead Sponsor: Chen Suning

Target Recruit Count: 188

Registration Number: NCT05177731

Locations: 🇨🇳
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou, Jiangsu, China

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

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia
Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Interventions: Drug: Lanraplenib
Drug: Gilteritinib

First Posted Date: 2021-08-31

Last Posted Date: 2024-08-07

Lead Sponsor: Kronos Bio

Target Recruit Count: 24

Registration Number: NCT05028751

Locations: 🇪🇸
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, Spain
🇺🇸
The Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 14 locations