Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

Draft scope assessment: unclear. Attached because the study's own record names FLT3. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

FLT3 mutation negative (evaluated by polymerase chain reaction \[PCR\]) Composite Complete Response (CRc) \[includes CR and CRi\] rate after induction treatment and complete MRD assessment. The cut points used for FLT3 mutation negative are 1% (equivalent to 10-2) for FLT3-TKD and 10-4 for FLT3-ITD.

Source null

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secondary · POSTED

CR evaluated by FLT3 testing after Induction

Source null

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secondary · POSTED

MRD- CRc evaluated by flow cytometry after Induction

Source null

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secondary · POSTED

CRc assessed in accordance with 2017 European LeukemiaNet (ELN)

Source null

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secondary · NOT_POSTED

EFS assessed in accordance with 2017 ELN

Source null

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secondary · NOT_POSTED

OS assessed in accordance with 2017 ELN

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id: NCT03836209
trial label: Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
applicability: unclear
applicability note: Attached because the study's own record names FLT3. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0000
source section id
NCT03836209-om-0000
source outcome index
0
endpoint
FLT3 Mutation Negative Composite Complete Response (CRc) [Includes Complete Response (CR) or CR With Incomplete Hematologic Recovery (CRi)] at End of Induction
endpoint definition
FLT3 mutation negative (evaluated by polymerase chain reaction \[PCR\]) Composite Complete Response (CRc) \[includes CR and CRi\] rate after induction treatment and complete MRD assessment. The cut points used for FLT3 mutation negative are 1% (equivalent to 10-2) for FLT3-TKD and 10-4 for FLT3-ITD.
time origin
3 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0001
source section id
NCT03836209-om-0001
source outcome index
1
endpoint
FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction
endpoint definition
CR evaluated by FLT3 testing after Induction
time origin
3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0002
source section id
NCT03836209-om-0002
source outcome index
2
endpoint
Minimal Residual Disease (MRD)- CRc Rate at End of Induction
endpoint definition
MRD- CRc evaluated by flow cytometry after Induction
time origin
3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0003
source section id
NCT03836209-om-0003
source outcome index
3
endpoint
CRc (CR or CRi) Rate at End of Induction
endpoint definition
CRc assessed in accordance with 2017 European LeukemiaNet (ELN)
time origin
3 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0004
source section id
NCT03836209-om-0004
source outcome index
4
endpoint
Event Free Survival (EFS)
endpoint definition
EFS assessed in accordance with 2017 ELN
time origin
68 months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0005
source section id
NCT03836209-om-0005
source outcome index
5
endpoint
Overall Survival (OS)
endpoint definition
OS assessed in accordance with 2017 ELN
time origin
68 months
analysis role
secondary
reporting status
NOT_POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0000
arm key
OG000
arm label
Arm A
regimen
Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0000
arm key
OG001
arm label
Arm B
regimen
Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0001
arm key
OG000
arm label
Arm A
regimen
Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0001
arm key
OG001
arm label
Arm B
regimen
Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0002
arm key
OG000
arm label
Arm A
regimen
Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0002
arm key
OG001
arm label
Arm B
regimen
Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0003
arm key
OG000
arm label
Arm A
regimen
Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and gilteritinib. Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8 Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
90
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
outcome key
om-0003
arm key
OG001
arm label
Arm B
regimen
Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given. Consolidation: High-dose cytarabine and midostaurin. Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8 Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles) Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3 Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3 Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1 Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles
analyzed count
87
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03836209-om-0003#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
harm key
EG000
source section id
NCT03836209-ae
event group key
EG000
event group label
Arm A
serious affected
48
serious at risk
90
other affected
83
other at risk
90
frequency threshold
5
collection period
Adverse events (AEs) are monitored during the 9 month treatment period for each patient, and for 30 days post-final dose, until resolution to ≤ grade 1 or stabilization, for a total of 10 months.
event definition
A serious adverse event (SAE) is any untoward medical occurrence after study treatment initiation that results in death, is life-threatening, requires or prolongs hospitalization, causes disability/incapacity, is a congenital anomaly, or, based on medical judgment, may jeopardize the patient or require intervention to prevent serious outcomes.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-vanflyta-dab15417
nct id
NCT03836209
harm key
EG001
source section id
NCT03836209-ae
event group key
EG001
event group label
Arm B
serious affected
39
serious at risk
87
other affected
81
other at risk
87
frequency threshold
5
collection period
Adverse events (AEs) are monitored during the 9 month treatment period for each patient, and for 30 days post-final dose, until resolution to ≤ grade 1 or stabilization, for a total of 10 months.
event definition
A serious adverse event (SAE) is any untoward medical occurrence after study treatment initiation that results in death, is life-threatening, requires or prolongs hospitalization, causes disability/incapacity, is a congenital anomaly, or, based on medical judgment, may jeopardize the patient or require intervention to prevent serious outcomes.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice