NCT01292603 · OUTCOME

Part 2: Percentage of Participants With Total B-Cell Depletion by Visit

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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 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

Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.

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 percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	0.0	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	0.0	Not reported	Not reported	Not reported	Not reported

Cycle 2 - Pre-dose (n=71, 74)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	23.9	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	31.1	Not reported	Not reported	Not reported	Not reported

Cycle 2 - Post-dose (n=65, 66)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	32.3	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	37.9	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 2 (n=54, 59)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	35.2	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	30.5	Not reported	Not reported	Not reported	Not reported

Cycle 2 Day 3 (n=48, 54)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	50.0	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	37.0	Not reported	Not reported	Not reported	Not reported

Cycle 3 Day 1 (n=67,68)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	73.1	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	76.5	Not reported	Not reported	Not reported	Not reported

Cycle 4 Day 1 (n=71,69)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	83.1	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	84.1	Not reported	Not reported	Not reported	Not reported

Cycle 5 Day 1 (n=68,67)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	88.2	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	89.6	Not reported	Not reported	Not reported	Not reported

Cycle 6 Day 1 (n=71,64)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	95.8	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	95.3	Not reported	Not reported	Not reported	Not reported

FU 28 Day Visit (n=66,64)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	95.5	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	96.9	Not reported	Not reported	Not reported	Not reported

FU 56 Day Visit (n=63,67)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	92.1	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	97.0	Not reported	Not reported	Not reported	Not reported

FU 3 Month Visit (n=67,67)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	95.5	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	92.5	Not reported	Not reported	Not reported	Not reported

FU 6 Month Visit (n=60,69)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	88.3	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	91.3	Not reported	Not reported	Not reported	Not reported

FU 9 Month Visit (n=65,64)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	66.2	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	70.3	Not reported	Not reported	Not reported	Not reported

FU 12 Month Visit (n=60,61)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	43.3	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	42.6	Not reported	Not reported	Not reported	Not reported

FU 15 Month Visit (n=59,60)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	33.9	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	30.0	Not reported	Not reported	Not reported	Not reported

FU 18 Month Visit (n=57,58)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	24.6	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	25.9	Not reported	Not reported	Not reported	Not reported

FU 21 Month Visit (n=55,52)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	14.5	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	19.2	Not reported	Not reported	Not reported	Not reported

FU 24 Month Visit (n=56,51)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	10.7	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	15.7	Not reported	Not reported	Not reported	Not reported

Withdrawn/Termination (n=17,15)

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2 : Rituximab IV 500 mg/m^2	41.2	Not reported	Not reported	Not reported	Not reported
Part 2: Rituximab SC 1600 mg	73.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
0.0
title
Cycle 1 - Baseline (n=80,80))
categories
measurements
group Id
OG000
value
23.9
group Id
OG001
value
31.1
title
Cycle 2 - Pre-dose (n=71, 74)
categories
measurements
group Id
OG000
value
32.3
group Id
OG001
value
37.9
title
Cycle 2 - Post-dose (n=65, 66)
categories
measurements
group Id
OG000
value
35.2
group Id
OG001
value
30.5
title
Cycle 2 Day 2 (n=54, 59)
categories
measurements
group Id
OG000
value
50.0
group Id
OG001
value
37.0
title
Cycle 2 Day 3 (n=48, 54)
categories
measurements
group Id
OG000
value
73.1
group Id
OG001
value
76.5
title
Cycle 3 Day 1 (n=67,68)
categories
measurements
group Id
OG000
value
83.1
group Id
OG001
value
84.1
title
Cycle 4 Day 1 (n=71,69)
categories
measurements
group Id
OG000
value
88.2
group Id
OG001
value
89.6
title
Cycle 5 Day 1 (n=68,67)
categories
measurements
group Id
OG000
value
95.8
group Id
OG001
value
95.3
title
Cycle 6 Day 1 (n=71,64)
categories
measurements
group Id
OG000
value
95.5
group Id
OG001
value
96.9
title
FU 28 Day Visit (n=66,64)
categories
measurements
group Id
OG000
value
92.1
group Id
OG001
value
97.0
title
FU 56 Day Visit (n=63,67)
categories
measurements
group Id
OG000
value
95.5
group Id
OG001
value
92.5
title
FU 3 Month Visit (n=67,67)

denoms

counts
group Id
OG000
value
89
group Id
OG001
value
85
units
Participants

description

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

NUMBER

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 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

title

Part 2: Percentage of Participants With Total B-Cell Depletion by Visit

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice