Gilteritinib
Treatment for Acute Myeloid Leukemia
Typical Dosage: Gilteritinib 120 mg orally once daily
Effectiveness
70%
Safety Score
45%
Clinical Trials
58
Participants
700
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
45
DangerousModerateSafe
Treatment Details
Dosage Range
Gilteritinib 120 mg orally once daily
Time to Effect
1-2 months
Treatment Duration
Continuous until disease progression or unacceptable toxicity
Evidence Quality
HIGHNumber Needed to Treat (NNT)
6(Treat 6 patients to see 1 additional successful outcome)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$330,000
Monitoring:$50,000
Side Effect Mgmt:$25,000
Total Annual:$405,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$629,000/QALY
QALYs Gained
0.7
Outcome-Based Costs
Cost per Responder
$1,191,176
Cost per Remission
$1,191,176
Comparison vs Salvage Chemotherapy
Cost Difference
+$250,000/year
More expensive
QALY Difference
+0.28 QALYs
Better outcomes
Dominance
No dominance
Gilteritinib Outcomes
for Acute Myeloid Leukemia
Efficacy Outcomes
Overall Effectiveness
+70%
Response Rate
+34%
Remission Rate
+34%
Common Side Effects
Transaminitis
+45%
Myalgia/arthralgia
+35%
Fatigue
+35%
Diarrhea/Constipation
+35%
Febrile neutropenia
+35%
QT prolongation
+7%
Active Clinical Trials
6 active trials recruiting for Gilteritinib in Acute Myeloid Leukemia
A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML
NCT05199051ACTIVE NOT RECRUITINGPHASE2
19 participants
INTERVENTIONAL
Amiens, France +11 more
Started: Jun 3, 2023
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia
NCT06235801RECRUITINGPHASE1, PHASE2
20 participants
INTERVENTIONAL
Houston, United States
Started: May 22, 2024
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
NCT05520567RECRUITINGPHASE1, PHASE2
70 participants
INTERVENTIONAL
Duarte, United States +19 more
Started: Jan 31, 2023
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
NCT03836209ACTIVE NOT RECRUITINGPHASE2
181 participants
INTERVENTIONAL
Scottsdale, United States +43 more
Started: Dec 6, 2019
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
NCT05756777RECRUITINGPHASE1
36 participants
INTERVENTIONAL
Basking Ridge, United States +6 more
Started: Jun 26, 2023
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
NCT05546580RECRUITINGPHASE1
50 participants
INTERVENTIONAL
Gilbert, United States +12 more
Started: Nov 14, 2022
Completed Clinical Trials
9 completed trials for Gilteritinib in Acute Myeloid Leukemia
Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
NCT06734585COMPLETED
114 participants
OBSERVATIONAL
Melbourne, Australia +17 more
Started: Jan 9, 2025
Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02181660COMPLETEDPHASE1
24 participants
INTERVENTIONAL
Aichi, Japan +4 more
Started: Jun 16, 2014
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)
NCT02997202COMPLETEDPHASE3
356 participants
INTERVENTIONAL
Birmingham, United States +117 more
Started: Aug 16, 2017
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
NCT03625505COMPLETEDPHASE1
61 participants
INTERVENTIONAL
Los Angeles, United States +10 more
Started: Oct 18, 2018
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
NCT02310321COMPLETEDPHASE1, PHASE2
97 participants
INTERVENTIONAL
Anjo, Japan +54 more
Started: Feb 26, 2015
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT02014558COMPLETEDPHASE1, PHASE2
265 participants
INTERVENTIONAL
Birmingham, United States +25 more
Started: Oct 9, 2013
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT02236013COMPLETEDPHASE1
80 participants
INTERVENTIONAL
Los Angeles, United States +9 more
Started: Jan 7, 2015
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
NCT02561455COMPLETEDPHASE1, PHASE2
9 participants
INTERVENTIONAL
Phoenix, United States +6 more
Started: May 3, 2016
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)
NCT03730012COMPLETEDPHASE1, PHASE2
11 participants
INTERVENTIONAL
Los Angeles, United States +11 more
Started: Jun 19, 2019
Showing 20 of 60 total trials