TriangleNCT02445248 · OUTCOME
Pharmacokinetics (Pk): T1/2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- days
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 60 months
What was measured
T1/2 is the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve in peripheral blood. T1/2, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame of 60 months reflects the maximum duration up to which the transgene levels were collected to measure the half life.
Analysis population: Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
Groups in this outcome
Tisagenlecleucel - Main Cohort: CR/PR
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
Tisagenlecleucel - Main Cohort: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
Tisagenlecleucel - Cohort A: CR/PR
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
Tisagenlecleucel - Cohort A: SD/PD/UNK
Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
| Group | Source count |
|---|---|
| Tisagenlecleucel - Main Cohort: CR/PR | 28 |
| Tisagenlecleucel - Main Cohort: SD/PD/UNK | 40 |
| Tisagenlecleucel - Cohort A: CR/PR | 3 |
| Tisagenlecleucel - Cohort A: SD/PD/UNK | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tisagenlecleucel - Main Cohort: CR/PR | 167 | 355.3 | Not reported | Not reported | Not reported |
| Tisagenlecleucel - Main Cohort: SD/PD/UNK | 10.9 | 205.4 | Not reported | Not reported | Not reported |
| Tisagenlecleucel - Cohort A: CR/PR | 59.4 | 30402.1 | Not reported | Not reported | Not reported |
| Tisagenlecleucel - Cohort A: SD/PD/UNK | 15.6 | 163.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 355.3
- value
- 167
- group Id
- OG001
- spread
- 205.4
- value
- 10.9
- group Id
- OG002
- spread
- 30402.1
- value
- 59.4
- group Id
- OG003
- spread
- 163.5
- value
- 15.6
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- units
- Participants
- description
- T1/2 is the half-life associated with the disposition phase slopes (alpha, beta, gamma etc.) of a semi logarithmic concentration-time curve in peripheral blood. T1/2, based on the transgene level data by qPCR, was summarized by Month 3 response, per Independent Review Committee assessment. This time frame of 60 months reflects the maximum duration up to which the transgene levels were collected to measure the half life.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
- id
- OG000
- title
- Tisagenlecleucel - Main Cohort: CR/PR
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
- id
- OG001
- title
- Tisagenlecleucel - Main Cohort: SD/PD/UNK
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
- id
- OG002
- title
- Tisagenlecleucel - Cohort A: CR/PR
- description
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
- id
- OG003
- title
- Tisagenlecleucel - Cohort A: SD/PD/UNK
- param Type
- GEOMETRIC_MEAN
- population Description
- Full Analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel with valid PK assessments.
- reporting Status
- POSTED
- time Frame
- 60 months
- title
- Pharmacokinetics (Pk): T1/2
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice