TriangleNCT02101853 · OUTCOME
Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
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
- 95% Confidence Interval
- Time frame
- Up to 3 years from date of randomization
What was measured
DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated.
Analysis population: LR patients randomized per protocol. This is the cohort of patients who were included in the primary analysis addressing the primary objective on LR patients. Of the total of 256 randomized LR patients, 1 patient was found to be ineligible and was excluded.
Groups in this outcome
Arm C (LR Control)
Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance. CNS3 patients receive chemoradiation post-Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.
Arm D (LR Blinatumomab)
Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance. CNS3 patients receive chemoradiation post Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.
| Group | Source count |
|---|---|
| Arm C (LR Control) | 128 |
| Arm D (LR Blinatumomab) | 127 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm C (LR Control) | 58.94 | Not reported | 49.08 | 67.53 | Not reported |
| Arm D (LR Blinatumomab) | 67.00 | Not reported | 57.36 | 74.94 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.08
- upper Limit
- 67.53
- value
- 58.94
- group Id
- OG001
- lower Limit
- 57.36
- upper Limit
- 74.94
- value
- 67.00
- denoms
- counts
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 127
- units
- Participants
- description
- DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8 weeks, Continuation 2 over 8 weeks, and then Maintenance. CNS3 patients receive chemoradiation post-Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.
- id
- OG000
- title
- Arm C (LR Control)
- description
- Patients receive Block 2 over 4 weeks, Blinatumomab Cycle 1 over 5 weeks, Continuation 1 over 8 weeks, Blinatumomab Cycle 2 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab Cycle 3 over 5 weeks, and then Maintenance. CNS3 patients receive chemoradiation post Maintenance Cycle 1. Patients with persistent testicular involvement after Block 1 receive testicular radiation during Block 2.
- id
- OG001
- title
- Arm D (LR Blinatumomab)
- param Type
- NUMBER
- population Description
- LR patients randomized per protocol. This is the cohort of patients who were included in the primary analysis addressing the primary objective on LR patients. Of the total of 256 randomized LR patients, 1 patient was found to be ineligible and was excluded.
- reporting Status
- POSTED
- time Frame
- Up to 3 years from date of randomization
- title
- Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice