TriangleNCT03483103 · OUTCOME
Event-Free Survival (EFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)
What was measured
EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake \> mediastinum but ≤ liver; 4-uptake moderately \> liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
Analysis population: All participants with PET positive disease who received at least one infusion of JCAR017
Groups in this outcome
Lisocabtagene Maraleucel (JCAR017)
Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
| Group | Source count |
|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 61 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 7.23 | Not reported | 3.22 | 24.28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.22
- upper Limit
- 24.28
- value
- 7.23
- denoms
- counts
- group Id
- OG000
- value
- 61
- units
- Participants
- description
- EFS is defined as the time from JCAR017 infusion to the earliest of the following events: death from any cause, progressive disease (PD), or starting a new anticancer therapy. Kaplan-Meier (KM) methodology will be used to analyze EFS. PD = Score 4 or 5b on PET 5PS with an increase in intensity of uptake from baseline and/or new fluorodeoxyglucose-avid foci consistent with lymphoma at interim or end-of-treatment assessment. PET 5PS = 1-no uptake above background; 2-uptake ≤ mediastinum; 3-uptake \> mediastinum but ≤ liver; 4-uptake moderately \> liver; 5-uptake markedly higher than liver and/or new lesions; X- new areas of uptake unlikely to be related to lymphoma.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants underwent leukapheresis and may receive salvage low- dose chemotherapy or one cycle of non-curative standard of care antitumor therapy if required. Eligible participants then received lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by a single dose of JCAR017 (100×10\^6 CAR+ T cells) administered intravenously (IV) 2 to 7 days after completion of lymphodepleting chemotherapy.
- id
- OG000
- title
- Lisocabtagene Maraleucel (JCAR017)
- param Type
- MEDIAN
- population Description
- All participants with PET positive disease who received at least one infusion of JCAR017
- reporting Status
- POSTED
- time Frame
- From first dose to death from any cause, progressive disease (PD), or starting a new anticancer therapy (up to approximately 24 months)
- title
- Event-Free Survival (EFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice