NCT03391466 · BASELINE

Baseline characteristics

Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma · Source last updated 2025-12-01

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

denoms

counts
group Id
BG000
value
180
group Id
BG001
value
179
group Id
BG002
value
359
units
Participants

groups

description
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg on Day 0.
id
BG000
title
Axicabtagene Ciloleucel
description
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
id
BG001
title
Standard of Care Therapy
description
Total of all reporting groups
id
BG002
title
Total

measures

calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
129
group Id
BG001
value
121
group Id
BG002
value
250
title
Between 18 and 65 years
measurements
group Id
BG000
value
51
group Id
BG001
value
58
group Id
BG002
value
109
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
12.0
value
57.1
group Id
BG001
spread
12.2
value
57.4
group Id
BG002
spread
12.1
value
57.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
70
group Id
BG001
value
52
group Id
BG002
value
122
title
Female
measurements
group Id
BG000
value
110
group Id
BG001
value
127
group Id
BG002
value
237
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
18
title
Hispanic or Latino
measurements
group Id
BG000
value
167
group Id
BG001
value
169
group Id
BG002
value
336
title
Not Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
12
group Id
BG001
value
10
group Id
BG002
value
22
title
Asian
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
11
group Id
BG001
value
7
group Id
BG002
value
18
title
Black or African American
measurements
group Id
BG000
value
145
group Id
BG001
value
152
group Id
BG002
value
297
title
White
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
18
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
130
group Id
BG001
value
120
group Id
BG002
value
250
title
United States
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
8
group Id
BG002
value
12
title
United Kingdom
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Switzerland
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
9
group Id
BG002
value
15
title
Spain
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
20
title
Canada
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
7
title
Belgium
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
Netherlands
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Sweden
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Italy
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Israel
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Australia
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
France
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

The Full Analysis Set (FAS) consisted of all randomized participants.

Complete source fields

denoms

counts
group Id
BG000
value
180
group Id
BG001
value
179
group Id
BG002
value
359
units
Participants

groups

description
Participants received cyclophosphamide 500 mg/m\^2/day IV infusion and fludarabine 30 mg/m\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-CD 19 CAR transduced autologous T cells/kg on Day 0.
id
BG000
title
Axicabtagene Ciloleucel
description
Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen: * R-ICE: rituximab 375mg/m\^2 before chemotherapy, ifosfamide 5g/m\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\^2/day on Days 1-3; * R-ESHAP: rituximab 375mg/m\^2 Day 1, etoposide 40mg/m\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\^2/day CI Days 1-4, cytarabine 2g/m\^2 on Day 5; * R-GDP: rituximab 375mg/m\^2 Day 1 (or Day 8), gemcitabine 1g/m\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\^2 Day 1 or carboplatin AUC=5; or * R-DHAP: rituximab 375mg/m\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\^2. Participants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.
id
BG001
title
Standard of Care Therapy
description
Total of all reporting groups
id
BG002
title
Total

measures

calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
129
group Id
BG001
value
121
group Id
BG002
value
250
title
Between 18 and 65 years
measurements
group Id
BG000
value
51
group Id
BG001
value
58
group Id
BG002
value
109
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
12.0
value
57.1
group Id
BG001
spread
12.2
value
57.4
group Id
BG002
spread
12.1
value
57.2
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
70
group Id
BG001
value
52
group Id
BG002
value
122
title
Female
measurements
group Id
BG000
value
110
group Id
BG001
value
127
group Id
BG002
value
237
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
18
title
Hispanic or Latino
measurements
group Id
BG000
value
167
group Id
BG001
value
169
group Id
BG002
value
336
title
Not Hispanic or Latino
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
12
group Id
BG001
value
10
group Id
BG002
value
22
title
Asian
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
11
group Id
BG001
value
7
group Id
BG002
value
18
title
Black or African American
measurements
group Id
BG000
value
145
group Id
BG001
value
152
group Id
BG002
value
297
title
White
measurements
group Id
BG000
value
10
group Id
BG001
value
8
group Id
BG002
value
18
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
calculate Pct
false
classes
categories
measurements
group Id
BG000
value
130
group Id
BG001
value
120
group Id
BG002
value
250
title
United States
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
8
group Id
BG002
value
12
title
United Kingdom
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Switzerland
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
9
group Id
BG002
value
15
title
Spain
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
10
group Id
BG002
value
20
title
Canada
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
7
title
Belgium
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
title
Netherlands
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Sweden
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
title
Italy
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Israel
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Australia
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
France
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants

population Description

The Full Analysis Set (FAS) consisted of all randomized participants.

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

Preserved source evidence · Not medical advice