NCT02421939 · BASELINE

Baseline characteristics

A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation · Source last updated 2025-12-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants

groups

description
Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
id
BG000
title
Gilteritinib
description
Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
id
BG001
title
Salvage Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
14.6
value
59
group Id
BG001
spread
14.8
value
57.6
group Id
BG002
spread
14.7
value
58.5
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
131
group Id
BG001
value
70
group Id
BG002
value
201
title
Female
measurements
group Id
BG000
value
116
group Id
BG001
value
54
group Id
BG002
value
170
title
Male
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
145
group Id
BG001
value
75
group Id
BG002
value
220
title
WHITE
measurements
group Id
BG000
value
69
group Id
BG001
value
33
group Id
BG002
value
102
title
ASIAN
measurements
group Id
BG000
value
14
group Id
BG001
value
7
group Id
BG002
value
21
title
BLACK OR AFRICAN AMERICAN
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
AMERICAN INDIAN OR ALASKA NATIVE
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
UNKNOWN
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
title
OTHER
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
MISSING
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
221
group Id
BG001
value
116
group Id
BG002
value
337
title
NOT HISPANIC OR LATINO
measurements
group Id
BG000
value
12
group Id
BG001
value
2
group Id
BG002
value
14
title
HISPANIC OR LATINO
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
UNKNOWN
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
MISSING
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
182
group Id
BG001
value
89
group Id
BG002
value
271
title
INTERMEDIATE
measurements
group Id
BG000
value
26
group Id
BG001
value
11
group Id
BG002
value
37
title
UNFAVORABLE
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
FAVORABLE
measurements
group Id
BG000
value
35
group Id
BG001
value
23
group Id
BG002
value
58
title
OTHER
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
description
The category of "Other" includes those with cytogenetic risk status that cannot be categorized as favorable, intermediate or unfavorable.
param Type
COUNT_OF_PARTICIPANTS
title
Cytogenic Risk Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
206
group Id
BG001
value
105
group Id
BG002
value
311
title
0-1
measurements
group Id
BG000
value
41
group Id
BG001
value
19
group Id
BG002
value
60
title
>=2
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
description
ECOG performance status is a scale used to assess impact on daily activities. It is based on the investigator assessment. Scores range from 0 to 5, with 0-signifying fully active participant; 1-restricted in physically strenuous activity; 2-ambulatory and capable of all self-care, unable to work; 3-capable of only limited self-care, confined to bed more than 50% of waking hours; 4-completely disabled and 5-dead. Negative numerical score indicates an improvement and positive numerical score indicates a decline in participant's daily activities, indicating disease progression.
param Type
COUNT_OF_PARTICIPANTS
title
Baseline Eastern Cooperative Oncology Group (ECOG)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
215
group Id
BG001
value
113
group Id
BG002
value
328
title
FLT3-ITD Alone
measurements
group Id
BG000
value
21
group Id
BG001
value
10
group Id
BG002
value
31
title
FLT3-TKD Alone
measurements
group Id
BG000
value
7
group Id
BG001
value
0
group Id
BG002
value
7
title
FLT3-ITD and FLT3-TKD
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Others (Unknown/Missing/Negative)
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
FLT3 Mutation Status by Central Testing by FLT3 CDx
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
215
group Id
BG001
value
110
group Id
BG002
value
325
title
No
measurements
group Id
BG000
value
32
group Id
BG001
value
14
group Id
BG002
value
46
title
Yes
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
description
Prior use of FLT3 inhibitor is defined as 'Yes' if participants received prior AML therapy of midostaurin, sorafenib or quizartinib; otherwise, prior use of FLT3 inhibitor is assigned as No.
param Type
COUNT_OF_PARTICIPANTS
title
Prior Use of FLT3 Inhibitor
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
114
group Id
BG001
value
52
group Id
BG002
value
166
title
NORTH AMERICA
measurements
group Id
BG000
value
68
group Id
BG001
value
43
group Id
BG002
value
111
title
EUROPE
measurements
group Id
BG000
value
65
group Id
BG001
value
29
group Id
BG002
value
94
title
ASIA
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Region
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
0.281
value
1.815
group Id
BG001
spread
0.257
value
1.777
group Id
BG002
spread
0.272
value
1.8
denoms
counts
group Id
BG000
value
199
group Id
BG001
value
122
group Id
BG002
value
321
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The analysis population was the ITT, with available data.
title
Baseline Body Surface Area (BSA)
unit Of Measure
m^2
classes
categories
measurements
group Id
BG000
spread
10.31
value
167.25
group Id
BG001
spread
10.63
value
166.39
group Id
BG002
spread
10.41
value
166.95
denoms
counts
group Id
BG000
value
234
group Id
BG001
value
123
group Id
BG002
value
357
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The analysis population was the ITT, with available data.
title
Baseline Height
unit Of Measure
centimeter (cm)
classes
categories
measurements
group Id
BG000
spread
20.47
value
72.79
group Id
BG001
spread
19.73
value
69.91
group Id
BG002
spread
20.25
value
71.82
denoms
counts
group Id
BG000
value
243
group Id
BG001
value
124
group Id
BG002
value
367
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The analysis population was the ITT, with available data.
title
Baseline Weight
unit Of Measure
kilogram (kg)

population Description

The analysis population was the Intention to Treatment (ITT), which consisted of all randomized participants.

Complete source fields

denoms

counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants

groups

description
Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
id
BG000
title
Gilteritinib
description
Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
id
BG001
title
Salvage Chemotherapy
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
14.6
value
59
group Id
BG001
spread
14.8
value
57.6
group Id
BG002
spread
14.7
value
58.5
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
131
group Id
BG001
value
70
group Id
BG002
value
201
title
Female
measurements
group Id
BG000
value
116
group Id
BG001
value
54
group Id
BG002
value
170
title
Male
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
145
group Id
BG001
value
75
group Id
BG002
value
220
title
WHITE
measurements
group Id
BG000
value
69
group Id
BG001
value
33
group Id
BG002
value
102
title
ASIAN
measurements
group Id
BG000
value
14
group Id
BG001
value
7
group Id
BG002
value
21
title
BLACK OR AFRICAN AMERICAN
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
AMERICAN INDIAN OR ALASKA NATIVE
measurements
group Id
BG000
value
4
group Id
BG001
value
4
group Id
BG002
value
8
title
UNKNOWN
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
title
OTHER
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
MISSING
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
221
group Id
BG001
value
116
group Id
BG002
value
337
title
NOT HISPANIC OR LATINO
measurements
group Id
BG000
value
12
group Id
BG001
value
2
group Id
BG002
value
14
title
HISPANIC OR LATINO
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
UNKNOWN
measurements
group Id
BG000
value
11
group Id
BG001
value
4
group Id
BG002
value
15
title
MISSING
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
182
group Id
BG001
value
89
group Id
BG002
value
271
title
INTERMEDIATE
measurements
group Id
BG000
value
26
group Id
BG001
value
11
group Id
BG002
value
37
title
UNFAVORABLE
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
FAVORABLE
measurements
group Id
BG000
value
35
group Id
BG001
value
23
group Id
BG002
value
58
title
OTHER
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
description
The category of "Other" includes those with cytogenetic risk status that cannot be categorized as favorable, intermediate or unfavorable.
param Type
COUNT_OF_PARTICIPANTS
title
Cytogenic Risk Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
206
group Id
BG001
value
105
group Id
BG002
value
311
title
0-1
measurements
group Id
BG000
value
41
group Id
BG001
value
19
group Id
BG002
value
60
title
>=2
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
description
ECOG performance status is a scale used to assess impact on daily activities. It is based on the investigator assessment. Scores range from 0 to 5, with 0-signifying fully active participant; 1-restricted in physically strenuous activity; 2-ambulatory and capable of all self-care, unable to work; 3-capable of only limited self-care, confined to bed more than 50% of waking hours; 4-completely disabled and 5-dead. Negative numerical score indicates an improvement and positive numerical score indicates a decline in participant's daily activities, indicating disease progression.
param Type
COUNT_OF_PARTICIPANTS
title
Baseline Eastern Cooperative Oncology Group (ECOG)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
215
group Id
BG001
value
113
group Id
BG002
value
328
title
FLT3-ITD Alone
measurements
group Id
BG000
value
21
group Id
BG001
value
10
group Id
BG002
value
31
title
FLT3-TKD Alone
measurements
group Id
BG000
value
7
group Id
BG001
value
0
group Id
BG002
value
7
title
FLT3-ITD and FLT3-TKD
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Others (Unknown/Missing/Negative)
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
FLT3 Mutation Status by Central Testing by FLT3 CDx
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
215
group Id
BG001
value
110
group Id
BG002
value
325
title
No
measurements
group Id
BG000
value
32
group Id
BG001
value
14
group Id
BG002
value
46
title
Yes
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
description
Prior use of FLT3 inhibitor is defined as 'Yes' if participants received prior AML therapy of midostaurin, sorafenib or quizartinib; otherwise, prior use of FLT3 inhibitor is assigned as No.
param Type
COUNT_OF_PARTICIPANTS
title
Prior Use of FLT3 Inhibitor
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
114
group Id
BG001
value
52
group Id
BG002
value
166
title
NORTH AMERICA
measurements
group Id
BG000
value
68
group Id
BG001
value
43
group Id
BG002
value
111
title
EUROPE
measurements
group Id
BG000
value
65
group Id
BG001
value
29
group Id
BG002
value
94
title
ASIA
denoms
counts
group Id
BG000
value
247
group Id
BG001
value
124
group Id
BG002
value
371
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Region
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
0.281
value
1.815
group Id
BG001
spread
0.257
value
1.777
group Id
BG002
spread
0.272
value
1.8
denoms
counts
group Id
BG000
value
199
group Id
BG001
value
122
group Id
BG002
value
321
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The analysis population was the ITT, with available data.
title
Baseline Body Surface Area (BSA)
unit Of Measure
m^2
classes
categories
measurements
group Id
BG000
spread
10.31
value
167.25
group Id
BG001
spread
10.63
value
166.39
group Id
BG002
spread
10.41
value
166.95
denoms
counts
group Id
BG000
value
234
group Id
BG001
value
123
group Id
BG002
value
357
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The analysis population was the ITT, with available data.
title
Baseline Height
unit Of Measure
centimeter (cm)
classes
categories
measurements
group Id
BG000
spread
20.47
value
72.79
group Id
BG001
spread
19.73
value
69.91
group Id
BG002
spread
20.25
value
71.82
denoms
counts
group Id
BG000
value
243
group Id
BG001
value
124
group Id
BG002
value
367
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
The analysis population was the ITT, with available data.
title
Baseline Weight
unit Of Measure
kilogram (kg)

population Description

The analysis population was the Intention to Treatment (ITT), which consisted of all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice