TriangleNCT00075946 · OUTCOME
Time to Rituximab Failure (TTRF)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- years
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.
What was measured
TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).
Analysis population: Eligible patients who were randomized to one of the two arms for maintenance therapy.
Groups in this outcome
Rituximab Retreatment: Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Scheduled: Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Retreatment: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
Rituximab Scheduled: Non-Follicular Patients
Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
| Group | Source count |
|---|---|
| Rituximab Retreatment: Follicular Patients | 143 |
| Rituximab Scheduled: Follicular Patients | 146 |
| Rituximab Retreatment: Non-Follicular Patients | 23 |
| Rituximab Scheduled: Non-Follicular Patients | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Retreatment: Follicular Patients | 3.92 | Not reported | 3.09 | 4.93 | Not reported |
| Rituximab Scheduled: Follicular Patients | 4.32 | Not reported | 3.53 | 4.98 | Not reported |
| Rituximab Retreatment: Non-Follicular Patients | 1.39 | Not reported | 1.07 | NA | Upper boundary has not been reached |
| Rituximab Scheduled: Non-Follicular Patients | 4.83 | Not reported | 2.46 | NA | Upper boundary has not been reached |
Source statistical analyses
- ci Lower Limit
- 0.90
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.88
- estimate Comment
- Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.
- group Description
- The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.33
- param Type
- Hazard Ratio (HR)
- param Value
- 1.3
- statistical Method
- Log Rank
- ci Lower Limit
- 1.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.19
- estimate Comment
- Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.012
- param Type
- Hazard Ratio (HR)
- param Value
- 2.75
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.90
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.88
- estimate Comment
- Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in follicular patients.
- group Description
- The primary analysis is to compare the time to rituximab failure (TTRF) between the retreatment arm and the scheduled arm in follicular patients.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.33
- param Type
- Hazard Ratio (HR)
- param Value
- 1.3
- statistical Method
- Log Rank
- ci Lower Limit
- 1.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.19
- estimate Comment
- Hazard ratio is for Rituximab Retreatment Arm/Rituximab Scheduled Arm in non-follicular patients.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.012
- param Type
- Hazard Ratio (HR)
- param Value
- 2.75
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.09
- upper Limit
- 4.93
- value
- 3.92
- group Id
- OG001
- lower Limit
- 3.53
- upper Limit
- 4.98
- value
- 4.32
- comment
- Upper boundary has not been reached
- group Id
- OG002
- lower Limit
- 1.07
- upper Limit
- NA
- value
- 1.39
- comment
- Upper boundary has not been reached
- group Id
- OG003
- lower Limit
- 2.46
- upper Limit
- NA
- value
- 4.83
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 146
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 29
- units
- Participants
- description
- TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression \< 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
- id
- OG000
- title
- Rituximab Retreatment: Follicular Patients
- description
- Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
- id
- OG001
- title
- Rituximab Scheduled: Follicular Patients
- description
- Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
- id
- OG002
- title
- Rituximab Retreatment: Non-Follicular Patients
- description
- Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
- id
- OG003
- title
- Rituximab Scheduled: Non-Follicular Patients
- param Type
- MEDIAN
- population Description
- Eligible patients who were randomized to one of the two arms for maintenance therapy.
- reporting Status
- POSTED
- time Frame
- Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.
- title
- Time to Rituximab Failure (TTRF)
- type
- PRIMARY
- unit Of Measure
- years
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Preserved source evidence · Independent clinical review pending · Not medical advice