TriangleNCT02101853 · OUTCOME
Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) 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 2 years from date of randomization
What was measured
DFS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated.
Analysis population: HR and IR patients randomized per protocol prior to June 30, 2019. This is the cohort of patients who were included in the primary analysis addressing the primary objective on HR/IR patients. Of the total of 216 randomized HR/IR patients, 2 patients with randomization procedure errors and 6 patients randomized after June 30, 2019 were excluded.
Groups in this outcome
Arm A (HR and IR Control)
Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the Block 2.
Arm B (HR and IR Blinatumomab)
Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab.
| Group | Source count |
|---|---|
| Arm A (HR and IR Control) | 103 |
| Arm B (HR and IR Blinatumomab) | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (HR and IR Control) | 39.04 | Not reported | 29.13 | 48.81 | Not reported |
| Arm B (HR and IR Blinatumomab) | 54.44 | Not reported | 44.30 | 63.51 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.13
- upper Limit
- 48.81
- value
- 39.04
- group Id
- OG001
- lower Limit
- 44.30
- upper Limit
- 63.51
- value
- 54.44
- denoms
- counts
- group Id
- OG000
- value
- 103
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- DFS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). DFS is calculated as the time from randomization to date of first event (treatment failure, relapse, second malignancy, remission death) or date of last contact. Two-year DFS estimates will be calculated from date of randomization for both Arm A and Arm B. 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, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the Block 2.
- id
- OG000
- title
- Arm A (HR and IR Control)
- description
- Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks, and then undergo allogeneic HSCT if eligible. Patients with persistent testicular involvement after Block 1 receive testicular radiation during the first block of blinatumomab.
- id
- OG001
- title
- Arm B (HR and IR Blinatumomab)
- param Type
- NUMBER
- population Description
- HR and IR patients randomized per protocol prior to June 30, 2019. This is the cohort of patients who were included in the primary analysis addressing the primary objective on HR/IR patients. Of the total of 216 randomized HR/IR patients, 2 patients with randomization procedure errors and 6 patients randomized after June 30, 2019 were excluded.
- reporting Status
- POSTED
- time Frame
- Up to 2 years from date of randomization
- title
- Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice