NCT01011920 · BASELINE

Baseline characteristics

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma · Source last updated 2026-03-19

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

denoms

counts
group Id
BG000
value
75
group Id
BG001
value
69
group Id
BG002
value
75
group Id
BG003
value
219
units
Participants

groups

description
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
id
BG000
title
MTX + AraC
description
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
id
BG001
title
MTX + Ara-C + Rituximab
description
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
id
BG002
title
MTX + Ara-C + Rituximab+Thiotepa
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
<=18 years
measurements
group Id
BG000
value
75
group Id
BG001
value
69
group Id
BG002
value
75
group Id
BG003
value
219
title
Between 18 and 65 years
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
50
upper Limit
64
value
58
group Id
BG001
lower Limit
53
upper Limit
63
value
57
group Id
BG002
lower Limit
53
upper Limit
62
value
57
group Id
BG003
lower Limit
50
upper Limit
64
value
57
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
25
group Id
BG002
value
29
group Id
BG003
value
83
title
Female
measurements
group Id
BG000
value
46
group Id
BG001
value
44
group Id
BG002
value
46
group Id
BG003
value
136
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
0
group Id
BG002
value
5
group Id
BG003
value
11
title
Denmark
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
29
group Id
BG002
value
34
group Id
BG003
value
92
title
Italy
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
18
group Id
BG002
value
14
group Id
BG003
value
39
title
United Kingdom
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
2
title
Switzerland
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
21
group Id
BG002
value
22
group Id
BG003
value
75
title
Germany
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
46
group Id
BG002
value
51
group Id
BG003
value
145
title
ECOG 0-1
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
23
group Id
BG002
value
24
group Id
BG003
value
74
title
ECOG>1
description
Patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability graded as follows: 0\. Fully active, able to carry on all pre-disease performance without restriction; 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; 3. Capable of only limited selfcare; 4. Completely disabled; totally confined to bed or chair; 5. Dead
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
26
group Id
BG002
value
25
group Id
BG003
value
88
title
Increased LDH
measurements
group Id
BG000
value
38
group Id
BG001
value
43
group Id
BG002
value
50
group Id
BG003
value
131
title
No increased LDH
description
Increased serum lactate dehydrogenase concentration
param Type
COUNT_OF_PARTICIPANTS
title
Increased LDH
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
58
group Id
BG001
value
52
group Id
BG002
value
64
group Id
BG003
value
174
title
Deep lesions
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
11
group Id
BG003
value
45
title
No deep lesions
param Type
COUNT_OF_PARTICIPANTS
title
Deep lesions
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
33
group Id
BG002
value
35
group Id
BG003
value
101
title
Increased CSF protein
measurements
group Id
BG000
value
23
group Id
BG001
value
20
group Id
BG002
value
18
group Id
BG003
value
61
title
No increased CSF protein
measurements
group Id
BG000
value
19
group Id
BG001
value
16
group Id
BG002
value
22
group Id
BG003
value
57
title
Not recorded
param Type
COUNT_OF_PARTICIPANTS
title
Increased cerebrospinal fluid (CSF) protein
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
12
group Id
BG002
value
13
group Id
BG003
value
39
title
Low Risk
measurements
group Id
BG000
value
47
group Id
BG001
value
44
group Id
BG002
value
47
group Id
BG003
value
138
title
Intermediate Risk
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
15
group Id
BG003
value
42
title
High Risk
description
IELSG risk score is a widely used, 5-point prognostic model for primary central nervous system lymphoma (PCNSL) that predicts overall survival (OS) based on age (\>60), performance status (ECOG \>1), high serum LDH, high CSF protein, and deep brain involvement. Low risk: 80% 2 years OS; Intermediate risk: 48% 2 years OS; High risk: 15% 2 years OS.
param Type
COUNT_OF_PARTICIPANTS
title
International Extranodal Lymphoma Study Group (IELSG) risk score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
7
title
Intraocular disease
measurements
group Id
BG000
value
70
group Id
BG001
value
68
group Id
BG002
value
74
group Id
BG003
value
212
title
No intraocular disease
param Type
COUNT_OF_PARTICIPANTS
title
Intraocular disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
10
group Id
BG002
value
13
group Id
BG003
value
34
title
Meningeal involvement
measurements
group Id
BG000
value
45
group Id
BG001
value
43
group Id
BG002
value
40
group Id
BG003
value
128
title
No meningeal involvement
measurements
group Id
BG000
value
19
group Id
BG001
value
16
group Id
BG002
value
22
group Id
BG003
value
57
title
Not recorded
param Type
COUNT_OF_PARTICIPANTS
title
Meningeal involvement
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
45
group Id
BG001
value
40
group Id
BG002
value
41
group Id
BG003
value
126
title
Multiple lesions
measurements
group Id
BG000
value
30
group Id
BG001
value
29
group Id
BG002
value
34
group Id
BG003
value
93
title
No multiple lesions
param Type
COUNT_OF_PARTICIPANTS
title
Multiple lesions
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
75
group Id
BG001
value
69
group Id
BG002
value
75
group Id
BG003
value
219
units
Participants

groups

description
Arm A Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses
id
BG000
title
MTX + AraC
description
Arm B Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles
id
BG001
title
MTX + Ara-C + Rituximab
description
Arm C Rituximab 375 mg/m2 conventional infusion d -5 \& 0 Methotrexate 3.5 g/m2 0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion d 1 Cytarabine 2 g/m2 1 hr infusion, twice a day (every 12 hs.) d 2 - 3 Thiotepa 30 mg/m2 30 min. Infusion d 4 Methotrexate: Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min. + 3 g/m2 in 3-hr infusion) on day 1, every 3 weeks for a maximum of 4 courses. Ara-C: Cytarabine 2 g/m2 (1 hr infusion, twice a day every 12 hours), on d 2 - 3 every 3 weeks for a maximum of 4 courses Rituximab: Rituximab 375 mg/m2 conventional infusion on day - 5 \& 0 every 3 weeks for a maximum of 4 cycles Thiotepa: ARM C: Thiotepa 30 mg/m2 (30 min. Infusion) on day 4 every 3 weeks for a maximum of 4 courses ARM E: Thiotepa 5 mg/kg in 250 ml saline sol 2-hr inf. every 12 hrs days -5 \& -4
id
BG002
title
MTX + Ara-C + Rituximab+Thiotepa
description
Total of all reporting groups
id
BG003
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
<=18 years
measurements
group Id
BG000
value
75
group Id
BG001
value
69
group Id
BG002
value
75
group Id
BG003
value
219
title
Between 18 and 65 years
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
group Id
BG003
value
0
title
>=65 years
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
50
upper Limit
64
value
58
group Id
BG001
lower Limit
53
upper Limit
63
value
57
group Id
BG002
lower Limit
53
upper Limit
62
value
57
group Id
BG003
lower Limit
50
upper Limit
64
value
57
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
25
group Id
BG002
value
29
group Id
BG003
value
83
title
Female
measurements
group Id
BG000
value
46
group Id
BG001
value
44
group Id
BG002
value
46
group Id
BG003
value
136
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
0
group Id
BG002
value
5
group Id
BG003
value
11
title
Denmark
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
29
group Id
BG002
value
34
group Id
BG003
value
92
title
Italy
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
18
group Id
BG002
value
14
group Id
BG003
value
39
title
United Kingdom
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
2
title
Switzerland
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
21
group Id
BG002
value
22
group Id
BG003
value
75
title
Germany
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
46
group Id
BG002
value
51
group Id
BG003
value
145
title
ECOG 0-1
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
23
group Id
BG002
value
24
group Id
BG003
value
74
title
ECOG>1
description
Patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability graded as follows: 0\. Fully active, able to carry on all pre-disease performance without restriction; 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; 3. Capable of only limited selfcare; 4. Completely disabled; totally confined to bed or chair; 5. Dead
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
26
group Id
BG002
value
25
group Id
BG003
value
88
title
Increased LDH
measurements
group Id
BG000
value
38
group Id
BG001
value
43
group Id
BG002
value
50
group Id
BG003
value
131
title
No increased LDH
description
Increased serum lactate dehydrogenase concentration
param Type
COUNT_OF_PARTICIPANTS
title
Increased LDH
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
58
group Id
BG001
value
52
group Id
BG002
value
64
group Id
BG003
value
174
title
Deep lesions
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
11
group Id
BG003
value
45
title
No deep lesions
param Type
COUNT_OF_PARTICIPANTS
title
Deep lesions
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
33
group Id
BG002
value
35
group Id
BG003
value
101
title
Increased CSF protein
measurements
group Id
BG000
value
23
group Id
BG001
value
20
group Id
BG002
value
18
group Id
BG003
value
61
title
No increased CSF protein
measurements
group Id
BG000
value
19
group Id
BG001
value
16
group Id
BG002
value
22
group Id
BG003
value
57
title
Not recorded
param Type
COUNT_OF_PARTICIPANTS
title
Increased cerebrospinal fluid (CSF) protein
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
12
group Id
BG002
value
13
group Id
BG003
value
39
title
Low Risk
measurements
group Id
BG000
value
47
group Id
BG001
value
44
group Id
BG002
value
47
group Id
BG003
value
138
title
Intermediate Risk
measurements
group Id
BG000
value
14
group Id
BG001
value
13
group Id
BG002
value
15
group Id
BG003
value
42
title
High Risk
description
IELSG risk score is a widely used, 5-point prognostic model for primary central nervous system lymphoma (PCNSL) that predicts overall survival (OS) based on age (\>60), performance status (ECOG \>1), high serum LDH, high CSF protein, and deep brain involvement. Low risk: 80% 2 years OS; Intermediate risk: 48% 2 years OS; High risk: 15% 2 years OS.
param Type
COUNT_OF_PARTICIPANTS
title
International Extranodal Lymphoma Study Group (IELSG) risk score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
1
group Id
BG002
value
1
group Id
BG003
value
7
title
Intraocular disease
measurements
group Id
BG000
value
70
group Id
BG001
value
68
group Id
BG002
value
74
group Id
BG003
value
212
title
No intraocular disease
param Type
COUNT_OF_PARTICIPANTS
title
Intraocular disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
10
group Id
BG002
value
13
group Id
BG003
value
34
title
Meningeal involvement
measurements
group Id
BG000
value
45
group Id
BG001
value
43
group Id
BG002
value
40
group Id
BG003
value
128
title
No meningeal involvement
measurements
group Id
BG000
value
19
group Id
BG001
value
16
group Id
BG002
value
22
group Id
BG003
value
57
title
Not recorded
param Type
COUNT_OF_PARTICIPANTS
title
Meningeal involvement
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
45
group Id
BG001
value
40
group Id
BG002
value
41
group Id
BG003
value
126
title
Multiple lesions
measurements
group Id
BG000
value
30
group Id
BG001
value
29
group Id
BG002
value
34
group Id
BG003
value
93
title
No multiple lesions
param Type
COUNT_OF_PARTICIPANTS
title
Multiple lesions
unit Of Measure
Participants

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Preserved source evidence · Not medical advice