Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

Draft scope assessment: unclear. Attached because the study's own record names FLT3. The study record does not state mutation, so it may describe a different alteration of the same gene. 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

Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

Source null

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secondary · POSTED

Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.

Source null

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secondary · POSTED

DFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.

Source null

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secondary · POSTED

Relapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.

Source null

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secondary · POSTED

Overall survival was defined as the time from transplant to death due to any cause.

Source null

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secondary · POSTED

Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease

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-xospata-bab9e68c
nct id: NCT01883362
trial label: Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
applicability: unclear
applicability note: Attached because the study's own record names FLT3. The study record does not state mutation, so it may describe a different alteration of the same gene. 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: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0000
source section id
NCT01883362-om-0000
source outcome index
0
endpoint
Proportion of Participants With Relapse Free Survival (RFS) up to 18 Months Post Transplant (Full Analysis Set) by Kaplan-Meier Analysis
endpoint definition
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
time origin
date of transplant up to 18 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-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0001
source section id
NCT01883362-om-0001
source outcome index
1
endpoint
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 18 Months (Full Analysis Set) by Kaplan-Meier Analysis
endpoint definition
Relapse-free survival assesses the clinical benefit of remaining in remission free from relapse or death due to the disease. It was defined as the time from transplant to relapse or death due to the disease. Relapse following complete response was defined as reappearance of leukemic blasts in the peripheral blood or finding more than 5% blasts in the bone marrow.
time origin
Randomization to 18 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-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0002
source section id
NCT01883362-om-0002
source outcome index
2
endpoint
Proportion of Participants With Relapse Free Survival (RFS) - Time From Randomization up to 24 Months(Full Analysis Set) by Kaplan-Meier Analysis
endpoint definition
DFS was defined as the time from transplant to relapse or death due to any cause. If a patient had more than 1 event (e.g., relapse then death) then the earliest date was taken into account.
time origin
date of transplant up to 24 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-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0003
source section id
NCT01883362-om-0003
source outcome index
3
endpoint
Proportion of Participants With Relapse Free Survival (RFS) - Time From Transplant (Full Analysis Set) by Kaplan-Meier Analysis
endpoint definition
Relapse-free survival was defined as the time from transplant to relapse or death due to the disease 24 months post-transplant. If a patient had more than one event (e.g., relapse then death) then the earliest date was taken into account.
time origin
date of transplant up to 24 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-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0004
source section id
NCT01883362-om-0004
source outcome index
4
endpoint
Probability of Overall Survival - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
endpoint definition
Overall survival was defined as the time from transplant to death due to any cause.
time origin
date of transplant up to 24 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-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0005
source section id
NCT01883362-om-0005
source outcome index
5
endpoint
Probability of Non-relapse Mortality (NRM) - Date of Transplant up to 24 Months (Full Analysis Set) by Kaplan-Meier Analysis
endpoint definition
Non-relapse mortality (NRM) was defined as the time from transplant to death due to reasons other than relapse/progressive disease
time origin
date of transplant up to 24 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

arms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0000
arm key
OG000
arm label
Standard of Care With Midostaurin
regimen
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0000
arm key
OG001
arm label
Standard of Care
regimen
Patients received standard of care alone in the post SCT setting
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0001
arm key
OG000
arm label
Standard of Care With Midostaurin
regimen
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0001
arm key
OG001
arm label
Standard of Care
regimen
Patients received standard of care alone in the post SCT setting
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0002
arm key
OG000
arm label
Standard of Care With Midostaurin
regimen
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0002
arm key
OG001
arm label
Standard of Care
regimen
Patients received standard of care alone in the post SCT setting
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0003
arm key
OG000
arm label
Standard of Care With Midostaurin
regimen
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0003
arm key
OG001
arm label
Standard of Care
regimen
Patients received standard of care alone in the post SCT setting
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0004
arm key
OG000
arm label
Standard of Care With Midostaurin
regimen
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0004
arm key
OG001
arm label
Standard of Care
regimen
Patients received standard of care alone in the post SCT setting
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0004#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0005
arm key
OG000
arm label
Standard of Care With Midostaurin
regimen
Patients received standard of care in the post stem cell transplant (SCT) setting in addition to Midostaurin 50mg twice a day for 12 months (cycles).
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0005#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
outcome key
om-0005
arm key
OG001
arm label
Standard of Care
regimen
Patients received standard of care alone in the post SCT setting
analyzed count
30
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01883362-om-0005#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-xospata-bab9e68c
nct id
NCT01883362
harm key
EG000
source section id
NCT01883362-ae
event group key
EG000
event group label
Standard of Care With Midostaurin
serious affected
9
serious at risk
30
other affected
28
other at risk
30
frequency threshold
5
collection period
Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
event definition
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
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-xospata-bab9e68c
nct id
NCT01883362
harm key
EG001
source section id
NCT01883362-ae
event group key
EG001
event group label
Standard of Care
serious affected
15
serious at risk
30
other affected
26
other at risk
30
frequency threshold
5
collection period
Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
event definition
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
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-xospata-bab9e68c
nct id
NCT01883362
harm key
EG002
source section id
NCT01883362-ae
event group key
EG002
event group label
ALL Patients
serious affected
24
serious at risk
60
other affected
54
other at risk
60
frequency threshold
5
collection period
Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 12.5 months (treatment duration ranged from 0.2 to 11.5 months).
event definition
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
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