TriangleNCT01235793 · OUTCOME
One-year Progression-free Survival and Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- (1) One Year (2) Until date of death from any cause, assessed up to 2 years
What was measured
Efficacy of the DRBEAT Regimen will be assessed by analysis of 1. one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression\*, or death, (\*Progression is defined as meeting the response criteria listed in Table 4: Response Criteria for Primary Central Nervous System Lymphoma according to Abrey LE, Batchelor TT, Ferreri AJM et al.) and 2. Overall survival, defined as the time interval between the date of transplant and the date of death from any cause.
Groups in this outcome
DRBEAT Regimen
Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m2 (cumulative total dose of 1250 mg/m2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
| Group | Source count |
|---|---|
| DRBEAT Regimen | 11 |
Reported measurements
Progression Free Survival
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DRBEAT Regimen | 132 | Not reported | 38 | NA | 95% confidence interval upper bound not obtained (insufficient number of participants with events) |
Overall Survival
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DRBEAT Regimen | 564 | Not reported | 71 | NA | 95% confidence interval upper bound not obtained (insufficient number of participants with events) |
Complete source fields
- classes
- categories
- measurements
- comment
- 95% confidence interval upper bound not obtained (insufficient number of participants with events)
- group Id
- OG000
- lower Limit
- 38
- upper Limit
- NA
- value
- 132
- title
- Progression Free Survival
- categories
- measurements
- comment
- 95% confidence interval upper bound not obtained (insufficient number of participants with events)
- group Id
- OG000
- lower Limit
- 71
- upper Limit
- NA
- value
- 564
- title
- Overall Survival
- denoms
- counts
- group Id
- OG000
- value
- 11
- units
- Participants
- description
- Efficacy of the DRBEAT Regimen will be assessed by analysis of 1. one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression\*, or death, (\*Progression is defined as meeting the response criteria listed in Table 4: Response Criteria for Primary Central Nervous System Lymphoma according to Abrey LE, Batchelor TT, Ferreri AJM et al.) and 2. Overall survival, defined as the time interval between the date of transplant and the date of death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Temozolomide: The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m2 (cumulative total dose of 1250 mg/m2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
- id
- OG000
- title
- DRBEAT Regimen
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- (1) One Year (2) Until date of death from any cause, assessed up to 2 years
- title
- One-year Progression-free Survival and Overall Survival
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice