A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia · Source last updated 2018-12-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEDIAN
Unit
cells/μL
Interval / dispersion
Full Range
Time frame
Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit
What was measured
CD 19 is a surface antigen (protein) present on B-lymphocytes.
Analysis population: Part 2 SAP; n = number of participants analyzed at the specified visit.
Groups in this outcome
Part 2 : Rituximab IV 500 mg/m^2
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 2 : Rituximab IV 500 mg/m^2
89
Part 2: Rituximab SC 1600 mg
85
Reported measurements
Cycle 1 - Baseline (n=80,80)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
68905
Not reported
3996
277645
Not reported
Part 2: Rituximab SC 1600 mg
50565
Not reported
640
453292
Not reported
Cycle 2 - Pre-dose (n=71,74)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
338
Not reported
2
38252
Not reported
Part 2: Rituximab SC 1600 mg
253
Not reported
1
92469
Not reported
Cycle 2 - Post-dose (n=65, 66)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
163
Not reported
3
13026
Not reported
Part 2: Rituximab SC 1600 mg
168
Not reported
1
32615
Not reported
Cycle 2 Day 2 (n=54, 59)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
154
Not reported
6
10416
Not reported
Part 2: Rituximab SC 1600 mg
266
Not reported
0
40815
Not reported
Cycle 2 Day 3 (n=48, 54)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
87
Not reported
0
14769
Not reported
Part 2: Rituximab SC 1600 mg
125
Not reported
0
13229
Not reported
Cycle 3 Day 1 (n=67,68)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
12
Not reported
0
13118
Not reported
Part 2: Rituximab SC 1600 mg
8
Not reported
1
22392
Not reported
Cycle 4 Day 1 (n=71,69)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
4
Not reported
0
17827
Not reported
Part 2: Rituximab SC 1600 mg
4
Not reported
0
18672
Not reported
Cycle 5 Day 1 (n=68,67)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
2
Not reported
0
7146
Not reported
Part 2: Rituximab SC 1600 mg
2
Not reported
0
8542
Not reported
Cycle 6 Day 1 (n=71,64)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
3
Not reported
0
3612
Not reported
Part 2: Rituximab SC 1600 mg
3
Not reported
0
4234
Not reported
FU 28 Day Visit (n=66,64)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
2
Not reported
0
1299
Not reported
Part 2: Rituximab SC 1600 mg
2
Not reported
0
2749
Not reported
FU 56 Day Visit (n=63,67)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
2
Not reported
0
14331
Not reported
Part 2: Rituximab SC 1600 mg
2
Not reported
0
3539
Not reported
FU 3 Month Visit (n=67,67)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
2
Not reported
0
39037
Not reported
Part 2: Rituximab SC 1600 mg
2
Not reported
0
16413
Not reported
FU 6 Month Visit (n=60,69)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
3
Not reported
0
1356
Not reported
Part 2: Rituximab SC 1600 mg
3
Not reported
0
22630
Not reported
FU 9 Month Visit (n=65,64)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
35
Not reported
1
3776
Not reported
Part 2: Rituximab SC 1600 mg
30
Not reported
0
890
Not reported
FU 12 Month Visit (n=60,61)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
91
Not reported
4
9372
Not reported
Part 2: Rituximab SC 1600 mg
104
Not reported
1
1770
Not reported
FU 15 Month Visit (n=59,60)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
135
Not reported
6
16328
Not reported
Part 2: Rituximab SC 1600 mg
171
Not reported
5
9431
Not reported
FU 18 Month Visit (n=57,58)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
134
Not reported
5
15404
Not reported
Part 2: Rituximab SC 1600 mg
223
Not reported
3
22363
Not reported
FU 21 Month Visit (n=55,52)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
171
Not reported
5
7901
Not reported
Part 2: Rituximab SC 1600 mg
277
Not reported
5
39435
Not reported
FU 24 Month Visit (n=56,51)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
214
Not reported
0
78010
Not reported
Part 2: Rituximab SC 1600 mg
256
Not reported
6
10482
Not reported
Withdrawn/Termination (n=17,15)
Values in cells/μL · Interval/dispersion: Full Range
Group
Value
Spread
Lower
Upper
Comment
Part 2 : Rituximab IV 500 mg/m^2
150
Not reported
2
90310
Not reported
Part 2: Rituximab SC 1600 mg
6
Not reported
0
35325
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
lower Limit
3996
upper Limit
277645
value
68905
group Id
OG001
lower Limit
640
upper Limit
453292
value
50565
title
Cycle 1 - Baseline (n=80,80)
categories
measurements
group Id
OG000
lower Limit
2
upper Limit
38252
value
338
group Id
OG001
lower Limit
1
upper Limit
92469
value
253
title
Cycle 2 - Pre-dose (n=71,74)
categories
measurements
group Id
OG000
lower Limit
3
upper Limit
13026
value
163
group Id
OG001
lower Limit
1
upper Limit
32615
value
168
title
Cycle 2 - Post-dose (n=65, 66)
categories
measurements
group Id
OG000
lower Limit
6
upper Limit
10416
value
154
group Id
OG001
lower Limit
0
upper Limit
40815
value
266
title
Cycle 2 Day 2 (n=54, 59)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
14769
value
87
group Id
OG001
lower Limit
0
upper Limit
13229
value
125
title
Cycle 2 Day 3 (n=48, 54)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
13118
value
12
group Id
OG001
lower Limit
1
upper Limit
22392
value
8
title
Cycle 3 Day 1 (n=67,68)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
17827
value
4
group Id
OG001
lower Limit
0
upper Limit
18672
value
4
title
Cycle 4 Day 1 (n=71,69)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
7146
value
2
group Id
OG001
lower Limit
0
upper Limit
8542
value
2
title
Cycle 5 Day 1 (n=68,67)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
3612
value
3
group Id
OG001
lower Limit
0
upper Limit
4234
value
3
title
Cycle 6 Day 1 (n=71,64)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
1299
value
2
group Id
OG001
lower Limit
0
upper Limit
2749
value
2
title
FU 28 Day Visit (n=66,64)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
14331
value
2
group Id
OG001
lower Limit
0
upper Limit
3539
value
2
title
FU 56 Day Visit (n=63,67)
categories
measurements
group Id
OG000
lower Limit
0
upper Limit
39037
value
2
group Id
OG001
lower Limit
0
upper Limit
16413
value
2
title
FU 3 Month Visit (n=67,67)
denoms
counts
group Id
OG000
value
89
group Id
OG001
value
85
units
Participants
description
CD 19 is a surface antigen (protein) present on B-lymphocytes.
dispersion Type
Full Range
groups
description
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
id
OG000
title
Part 2 : Rituximab IV 500 mg/m^2
description
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
id
OG001
title
Part 2: Rituximab SC 1600 mg
param Type
MEDIAN
population Description
Part 2 SAP; n = number of participants analyzed at the specified visit.
reporting Status
POSTED
time Frame
Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit
Triangle