NCT03589326 · BASELINE

Baseline characteristics

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia · Source last updated 2025-11-26

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

denoms

counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants

groups

description
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
id
BG000
title
Cohort A: Ponatinib 30 mg
description
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
id
BG001
title
Cohort B: Imatinib 600 mg
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
16.09
value
51.2
group Id
BG001
spread
14.60
value
50.6
group Id
BG002
spread
15.59
value
51.0
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
90
group Id
BG001
value
43
group Id
BG002
value
133
title
Female
measurements
group Id
BG000
value
74
group Id
BG001
value
38
group Id
BG002
value
112
title
Male
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
20
group Id
BG001
value
11
group Id
BG002
value
31
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
Black or African American
measurements
group Id
BG000
value
104
group Id
BG001
value
62
group Id
BG002
value
166
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
28
group Id
BG001
value
2
group Id
BG002
value
30
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
20
group Id
BG002
value
59
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
105
group Id
BG001
value
56
group Id
BG002
value
161
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Non-Hispanic and Latino
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
4
group Id
BG002
value
19
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Not reported
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
8
group Id
BG002
value
22
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
China
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Korea, South
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Taiwan
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
1
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
France
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
10
group Id
BG002
value
38
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Poland
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Russia
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
9
group Id
BG002
value
25
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Turkey
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
9.980
value
167.24
group Id
BG001
spread
9.029
value
167.27
group Id
BG002
spread
9.662
value
167.25
denoms
counts
group Id
BG000
value
158
group Id
BG001
value
76
group Id
BG002
value
234
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed are the number of participants available for height at baseline.
title
Height
unit Of Measure
centimeters (cm)
classes
categories
measurements
group Id
BG000
spread
18.675
value
74.17
group Id
BG001
spread
18.565
value
76.23
group Id
BG002
spread
18.626
value
74.86
denoms
counts
group Id
BG000
value
163
group Id
BG001
value
81
group Id
BG002
value
244
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed are the number of participants available for weight at baseline.
title
Weight
unit Of Measure
kilograms (kg)
classes
categories
measurements
group Id
BG000
spread
0.261
value
1.84
group Id
BG001
spread
0.255
value
1.86
group Id
BG002
spread
0.258
value
1.85
denoms
counts
group Id
BG000
value
157
group Id
BG001
value
76
group Id
BG002
value
233
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed are the number of participants available for BSA at baseline.
title
Body Surface Area (BSA)
unit Of Measure
meters squared (m^2)

population Description

ITT analysis set was defined as all participants who were randomized.

Complete source fields

denoms

counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants

groups

description
Ponatinib 30 mg, tablets, orally, once daily (QD), with vincristine 1.4 mg/m\^2 (max 2 mg) intravenous (IV), on Days 1 and 14 and dexamethasone 40 mg (\<60 years \[yrs\]) and 20 mg (≥60 yrs), orally, once on Days 1 to 4, Days 11 to 14 for up to 3 cycles (each cycle=28 days) in induction phase (IP) (reduced dose of ponatinib 15 mg upon achievement of MRD-negative CR at end of induction) followed by ponatinib last induction phase dose with cytarabine, 1000 mg/m\^2 as 2-hour IV infusion (\<60 yrs) and 250 mg/m\^2 (≥60 yrs) every 12 hours, IV on Days 1, 3, 5 of Cycles 2,4,6 and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of cycles 1, 3, 5 in consolidation phase (CP) followed by ponatinib last consolidation phase dose with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg(≥70 yrs) on Days 1 to 5 for up to 11 cycles in maintenance phase (MP) up to data cut-off date: 12 August 2022.
id
BG000
title
Cohort A: Ponatinib 30 mg
description
Imatinib 600 mg, tablets, orally, QD, with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Days 1 and 14 and dexamethasone 40 mg (\<60 yrs) and 20 mg (≥60 yrs), orally, once on Days 1 to 4 and Days 11 to 14 in each 28-day cycle for up to 3 cycles in the induction phase followed by imatinib 600 mg, tablets, orally, QD, with cytarabine, 1000 mg/m\^2 every 12 hours as a 2-hour-IV infusion (\<60 yrs) and 250 mg/m\^2 every 12 hours (≥60 yrs), IV on Days 1, 3, and 5 of each 28-day even cycles (Cycles 2, 4, and 6), and methotrexate, 1000 mg/m\^2 (\<60 yrs) and 250 mg/m\^2 (≥60 yrs), IV infusion, on Day 1 of each 28-day odd cycles (Cycle 1, 3, and 5) in consolidation phase followed by imatinib 600 mg, tablets, orally, QD, along with vincristine 1.4 mg/m\^2 (max 2 mg), IV, on Day 1 and prednisone 200 mg (\<60 yrs), 100 mg (≥60-69 yrs) and 50 mg (≥70 yrs) on Days 1 through 5 in each 28-day cycle up to 11 cycles in maintenance phase up to data cut-off date: 12 August 2022.
id
BG001
title
Cohort B: Imatinib 600 mg
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
16.09
value
51.2
group Id
BG001
spread
14.60
value
50.6
group Id
BG002
spread
15.59
value
51.0
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
90
group Id
BG001
value
43
group Id
BG002
value
133
title
Female
measurements
group Id
BG000
value
74
group Id
BG001
value
38
group Id
BG002
value
112
title
Male
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
American Indian or Alaska Native
measurements
group Id
BG000
value
20
group Id
BG001
value
11
group Id
BG002
value
31
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
9
group Id
BG001
value
4
group Id
BG002
value
13
title
Black or African American
measurements
group Id
BG000
value
104
group Id
BG001
value
62
group Id
BG002
value
166
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
28
group Id
BG001
value
2
group Id
BG002
value
30
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
20
group Id
BG002
value
59
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
105
group Id
BG001
value
56
group Id
BG002
value
161
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Non-Hispanic and Latino
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
4
group Id
BG002
value
19
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Not reported
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Unknown
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Australia
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
8
group Id
BG002
value
22
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
China
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Korea, South
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Taiwan
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Austria
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
1
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
France
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
10
group Id
BG002
value
38
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Poland
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
6
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Russia
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
9
group Id
BG002
value
25
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
164
group Id
BG001
value
81
group Id
BG002
value
245
units
Participants
title
Turkey
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
9.980
value
167.24
group Id
BG001
spread
9.029
value
167.27
group Id
BG002
spread
9.662
value
167.25
denoms
counts
group Id
BG000
value
158
group Id
BG001
value
76
group Id
BG002
value
234
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed are the number of participants available for height at baseline.
title
Height
unit Of Measure
centimeters (cm)
classes
categories
measurements
group Id
BG000
spread
18.675
value
74.17
group Id
BG001
spread
18.565
value
76.23
group Id
BG002
spread
18.626
value
74.86
denoms
counts
group Id
BG000
value
163
group Id
BG001
value
81
group Id
BG002
value
244
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed are the number of participants available for weight at baseline.
title
Weight
unit Of Measure
kilograms (kg)
classes
categories
measurements
group Id
BG000
spread
0.261
value
1.84
group Id
BG001
spread
0.255
value
1.86
group Id
BG002
spread
0.258
value
1.85
denoms
counts
group Id
BG000
value
157
group Id
BG001
value
76
group Id
BG002
value
233
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed are the number of participants available for BSA at baseline.
title
Body Surface Area (BSA)
unit Of Measure
meters squared (m^2)

population Description

ITT analysis set was defined as all participants who were randomized.

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

Preserved source evidence · Not medical advice