NCT01200758 · OUTCOME
Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27
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
- Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
What was measured
Depletion is defined as a cluster of differentiation (CD) 19 value \<80 cells per cubic millimeter (cells/mm\^3).
Analysis population: ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.
Groups in this outcome
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
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 |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 188 |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 180 |
|---|
Reported measurements
Cycle 1 Day 1 - Baseline (n=188, 168)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 51.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 54.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 0 (n=183, 180)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 95.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 95.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1 (n=175, 175)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 99.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 99.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 4 Day 1 (n=178, 180)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 99.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1 (n=179, 176)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 6 Day 1 (n=173, 175)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 7 Day 1 (n=178, 173)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Cycle 8 Day 1 (n=175, 174)
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 100.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 51.6
- group Id
- OG001
- value
- 54.8
- title
- Cycle 1 Day 1 - Baseline (n=188, 168)
- categories
- measurements
- group Id
- OG000
- value
- 95.1
- group Id
- OG001
- value
- 95.0
- title
- Cycle 2 Day 0 (n=183, 180)
- categories
- measurements
- group Id
- OG000
- value
- 99.4
- group Id
- OG001
- value
- 99.4
- title
- Cycle 3 Day 1 (n=175, 175)
- categories
- measurements
- group Id
- OG000
- value
- 99.4
- group Id
- OG001
- value
- 100.0
- title
- Cycle 4 Day 1 (n=178, 180)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- title
- Cycle 5 Day 1 (n=179, 176)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- title
- Cycle 6 Day 1 (n=173, 175)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- title
- Cycle 7 Day 1 (n=178, 173)
- categories
- measurements
- group Id
- OG000
- value
- 100.0
- group Id
- OG001
- value
- 100.0
- title
- Cycle 8 Day 1 (n=175, 174)
- denoms
- counts
- group Id
- OG000
- value
- 188
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- Depletion is defined as a cluster of differentiation (CD) 19 value \<80 cells per cubic millimeter (cells/mm\^3).
- groups
- description
- Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
- id
- OG000
- title
- Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
- description
- First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
- id
- OG001
- title
- Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
- param Type
- NUMBER
- population Description
- ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.
- reporting Status
- POSTED
- time Frame
- Stage I and II (induction): for rituximab IV - D1 of Cy 1 to 8 (1 Cy=3 weeks); for rituximab SC - D1 of Cy 1 and Cy 3 to 8, D0 of Cy 2
- title
- Percentage of Participants With B-Cell Depletion by Cycle for Induction Phase
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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