NCT03483103 · OUTCOME
PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- day*copies/ug
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- From first dose to up to 24 months
What was measured
Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.
Analysis population: All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR
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) | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lisocabtagene Maraleucel (JCAR017) | 178631.0 | 228.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 228.3
- value
- 178631.0
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Pharmacokinetic (PK) analyses were based on quantitative polymerase chain reaction (qPCR). AUC (0-28) = Area under the curve for concentration.
- dispersion Type
- Geometric Coefficient of Variation
- 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
- GEOMETRIC_MEAN
- population Description
- All participants who received at least one infusion of JCAR017 who have baseline and on-study PK measurements assessed by qPCR
- reporting Status
- POSTED
- time Frame
- From first dose to up to 24 months
- title
- PK Parameters of JCAR017 in Blood as Assessed by qPCR: AUC (0-28)
- type
- SECONDARY
- unit Of Measure
- day*copies/ug
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle