Clinical trials: Gilteritinib
AML, Leukaemia (Acute Myeloid)
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose…
- Trial name
- AGORA-1 (NCT05199051)
- Testing
- Gemtuzumab ozogamicine - Cytarabine - Gilteritinib
- Where
- 12 sites in France
- Volunteers
- 19 people
- Sponsor
- Centre Antoine Lacassagne
AML With FLT3 Mutation
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
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with…
- Trial name
- NCT03182244
- Testing
- Gilteritinib, Cytarabine, Mitoxantrone
- Where
- 49 sites in China, Malaysia and 3 more
- Volunteers
- 276 people
- Sponsor
- Astellas Pharma Inc
Leukemia, Myeloid, Acute
A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).
- Trial name
- NCT04336982
- Testing
- CC-90009, Venetoclax, Azacitidine
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 22 people
- Sponsor
- Celgene
Acute Myeloid Leukemia
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies.
- Trial name
- HERKULES-4 (NCT05279859)
- Testing
- ERAS-007, ERAS-601, Gilteritinib
- Where
- 4 sites in United States
- Sponsor
- Erasca, Inc.
Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the safety of lanraplenib (LANRA) in combination with the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib, in participants with relapsed or refractory (R/R) FLT3-mutated…
- Conditions
- Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT05028751
- Testing
- Lanraplenib, Gilteritinib
- Where
- 17 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Kronos Bio
Acute Myeloid Leukemia, FLT3-mutated Acute Myeloid Leukemia
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status…
- Trial name
- NCT02310321
- Testing
- Gilteritinib, Idarubicin, Cytarabine
- Where
- 55 sites in Japan, South Korea and 1 more
- Volunteers
- 97 people
- Sponsor
- Astellas Pharma Inc
AML (Acute Myeloid Leukemia)
FLT3-ITD Targeted Therapy in Fit AML Patients
This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction…
- Trial name
- FIT-AML (NCT07425808)
- Testing
- Gilteritinib, Venetoclax, Azacitidine (AZA)
- Volunteers
- 230 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Gilteritinib for the Treatment of ALK NSCLC
This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments.
- Trial name
- NCT06225427
- Testing
- Biopsy, Biospecimen Collection, Computed Tomography
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan Rogel Cancer Center
Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML).
- Trial name
- HOVON 156 AML (NCT04027309)
- Testing
- Gilteritinib, Midostaurin
- Where
- 193 sites in Australia, Austria and 11 more
- Volunteers
- 777 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
Healthy Volunteer
A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects
The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib…
- Trial name
- NCT03964038
- Testing
- gilteritinib, gilteritinib mini tablet
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Refractory AML, Relapsed Adult AML
A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed (R/R) FLT3 Mutated Acute MyEloid Leukemia (AML) Patients Treated With Gilteritinib in FrANCE
Gilteritinib is available in early access in France through Temporary Authorisation of Use (or ATU program) since March 2019. The ATU program reflects a real-life treatment situation and the related clinical data would help to…
- Conditions
- Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation, FLT3-ITD
- Trial name
- ELEGANCE (NCT05193448)
- Where
- 38 sites in France
- Volunteers
- 177 people
- Sponsor
- French Innovative Leukemia Organisation
Acute Myeloid Leukemia
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
Eligible untreated patients with FLT3 acute myeloid leukemia (AML) between the ages of 18 and 70 will be randomized to receive gilteritinib or midostaurin during induction and consolidation.
- Trial name
- NCT03836209
- Testing
- Gilteritinib, Midostaurin, Daunorubicin
- Where
- 44 sites in United States
- Volunteers
- 181 people
- Sponsor
- PrECOG, LLC.
Myeloid Leukemia
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
To learn the recommended dose of momelotinib that can be given in combination with gilteritinib to participants with AML.
- Trial name
- NCT06235801
- Testing
- Gilteritinib, Momelotinib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Acute Myeloid Leukemia, Myelodysplastic Syndrome
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
This phase I/II trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is…
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT05010122
- Testing
- Decitabine and Cedazuridine, Gilteritinib, Venetoclax
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- M.D. Anderson Cancer Center
AML, Adult, Refractory AML
Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia
Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group.
- Conditions
- AML, Adult, Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation
- Trial name
- OGILAR (NCT06022003)
- Testing
- AzaCITIDine Oral Tablet, Xospata
- Where
- 20 sites in France
- Volunteers
- 33 people
- Sponsor
- French Innovative Leukemia Organisation
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences Inc.
AML
Individual Patient Expanded Access Gilteritinib (ASP2215)
The purpose of this study is to provide expanded access to ASP2215 for a single subject with refractory FLT3-mutated AML without access to comparable or alternative therapy.
- Trial name
- NCT03315299
- Testing
- ASP2215
- Where
- United States
- Sponsor
- Etan Orgel
Acute Myeloid Leukemia (AML)
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations.
- Trial name
- NCT05756777
- Testing
- Gilteritinib, Ivosidenib, Enasidenib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Acute Myeloid Leukemia
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)
The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to…
- Trial name
- NCT02997202
- Testing
- gilteritinib
- Where
- 118 sites in United States, Australia and 14 more
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive
Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML
This clinical trial aims to evaluate whether molecular MRD-guided chemotherapy can effectively treat FLT3-ITD mutated AML and potentially replace allogeneic hematopoietic stem cell transplantation.
- Conditions
- Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia, Fit Patients
- Trial name
- GANCE (NCT07259707)
- Testing
- GVA + HDAC Consolidation & Gilteritinib Maintenance
- Where
- China
- Volunteers
- 25 people
- Sponsor
- First Affiliated Hospital of Zhejiang University