NCT01292603 · OUTCOME
Part 1: 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
- Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24
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 1 SAP; n = number of participants analyzed at the specified visit.
Groups in this outcome
Part 1: Rituximab SC 1400 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 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 1: Rituximab SC 1600 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 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 1: Rituximab SC 1870 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 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).
Rituximab SC 1000 mg
Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 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 1: No SC Dose Received
These participants were withdrawn prior to SC treatment.
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 1: Rituximab SC 1400 mg | 16 |
|---|
| Part 1: Rituximab SC 1600 mg | 17 |
|---|
| Part 1: Rituximab SC 1870 mg | 22 |
|---|
| Rituximab SC 1000 mg | 1 |
|---|
| Part 1: No SC Dose Received | 8 |
|---|
Reported measurements
Cycle 5 Day 1 (n=15,1319,1,2)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 93.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 92.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: No SC Dose Received | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 6 Day 1(n= 15,14,18,1,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 93.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 28 Day Visit (n=15,11,19,1,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 93.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 56 Day Visit (n=15,9,15,1,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 93.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 3 Month Visit (n=16,8,18,0,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 93.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 6 Month Visit (n=15,13,17,1,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 86.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 92.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 94.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 9 Month Visit (n=15,13,15,1,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 53.3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 84.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 60.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 12 Month Visit (n=14,14,20,0,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 28.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 85.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 45.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 15 Month Visit (n=14,11,15,0,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 35.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 54.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 40.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 18 Month Visit (n=13,14,15,0,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 30.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 26.7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 21 Month Visit (n=13,12,16,0,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 30.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 18.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
FU 24 Month Visit (n=12,14,16,0,0)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 1: Rituximab SC 1400 mg | 25.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1600 mg | 21.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1: Rituximab SC 1870 mg | 18.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Rituximab SC 1000 mg | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
| Part 1: No SC Dose Received | NA | Not reported | Not reported | Not reported | No participants were analyzed in this group. |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 93.3
- group Id
- OG001
- value
- 92.3
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 0.0
- group Id
- OG004
- value
- 100.0
- title
- Cycle 5 Day 1 (n=15,1319,1,2)
- categories
- measurements
- group Id
- OG000
- value
- 93.3
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- Cycle 6 Day 1(n= 15,14,18,1,0)
- categories
- measurements
- group Id
- OG000
- value
- 93.3
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 28 Day Visit (n=15,11,19,1,0)
- categories
- measurements
- group Id
- OG000
- value
- 93.3
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- group Id
- OG003
- value
- 100.0
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 56 Day Visit (n=15,9,15,1,0)
- categories
- measurements
- group Id
- OG000
- value
- 93.8
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 100.0
- comment
- No participants were analyzed in this group.
- group Id
- OG003
- value
- NA
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 3 Month Visit (n=16,8,18,0,0)
- categories
- measurements
- group Id
- OG000
- value
- 86.7
- group Id
- OG001
- value
- 92.3
- group Id
- OG002
- value
- 94.1
- group Id
- OG003
- value
- 100.0
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 6 Month Visit (n=15,13,17,1,0)
- categories
- measurements
- group Id
- OG000
- value
- 53.3
- group Id
- OG001
- value
- 84.6
- group Id
- OG002
- value
- 60.0
- group Id
- OG003
- value
- 100.0
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 9 Month Visit (n=15,13,15,1,0)
- categories
- measurements
- group Id
- OG000
- value
- 28.6
- group Id
- OG001
- value
- 85.7
- group Id
- OG002
- value
- 45.0
- comment
- No participants were analyzed in this group.
- group Id
- OG003
- value
- NA
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 12 Month Visit (n=14,14,20,0,0)
- categories
- measurements
- group Id
- OG000
- value
- 35.7
- group Id
- OG001
- value
- 54.5
- group Id
- OG002
- value
- 40.0
- comment
- No participants were analyzed in this group.
- group Id
- OG003
- value
- NA
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 15 Month Visit (n=14,11,15,0,0)
- categories
- measurements
- group Id
- OG000
- value
- 30.8
- group Id
- OG001
- value
- 50.0
- group Id
- OG002
- value
- 26.7
- comment
- No participants were analyzed in this group.
- group Id
- OG003
- value
- NA
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 18 Month Visit (n=13,14,15,0,0)
- categories
- measurements
- group Id
- OG000
- value
- 30.8
- group Id
- OG001
- value
- 50.0
- group Id
- OG002
- value
- 18.8
- comment
- No participants were analyzed in this group.
- group Id
- OG003
- value
- NA
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 21 Month Visit (n=13,12,16,0,0)
- categories
- measurements
- group Id
- OG000
- value
- 25.0
- group Id
- OG001
- value
- 21.4
- group Id
- OG002
- value
- 18.8
- comment
- No participants were analyzed in this group.
- group Id
- OG003
- value
- NA
- comment
- No participants were analyzed in this group.
- group Id
- OG004
- value
- NA
- title
- FU 24 Month Visit (n=12,14,16,0,0)
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 22
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 8
- units
- Participants
- description
- 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.
- groups
- description
- Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1400 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 1: Rituximab SC 1400 mg
- description
- Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1600 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 1: Rituximab SC 1600 mg
- description
- Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1870 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
- OG002
- title
- Part 1: Rituximab SC 1870 mg
- description
- Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m\^2 on Day 1 Cycle 6: SC rituximab 1000 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
- OG003
- title
- Rituximab SC 1000 mg
- description
- These participants were withdrawn prior to SC treatment.
- id
- OG004
- title
- Part 1: No SC Dose Received
- param Type
- NUMBER
- population Description
- Part 1 SAP; n = number of participants analyzed at the specified visit.
- reporting Status
- POSTED
- time Frame
- Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24
- title
- Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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