TriangleNCT03905135 · OUTCOME
Mean Event-free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Days
- Interval / dispersion
- Standard Deviation
- Time frame
- From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.
What was measured
EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first, and was estimated using Kaplan-Meier curves along with a 95% confidence interval. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
Groups in this outcome
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
| Group | Source count |
|---|---|
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 6 |
| Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 176 | 140 | Not reported | Not reported | Not reported |
| Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 33.54 | 0.98 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 140
- value
- 176
- group Id
- OG001
- spread
- 0.98
- value
- 33.54
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first, and was estimated using Kaplan-Meier curves along with a 95% confidence interval. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
- dispersion Type
- Standard Deviation
- groups
- description
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- id
- OG000
- title
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- description
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- id
- OG001
- title
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.
- title
- Mean Event-free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice