TriangleNCT03054298 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- Full Range
- Time frame
- 7 years
What was measured
Progression is defined using RECIST V1.1 - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Analysis population: Cohort 4 was permanently closed.
Groups in this outcome
Cohort 1
Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 2
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 3
PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 4
PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 5
Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 6
Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
Cohort 7
Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
| Group | Source count |
|---|---|
| Cohort 1 | 3 |
| Cohort 2 | 3 |
| Cohort 3 | 2 |
| Cohort 4 | 0 |
| Cohort 5 | 2 |
| Cohort 6 | 6 |
| Cohort 7 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 8.1 | Not reported | 4.1 | 13.1 | Not reported |
| Cohort 2 | 7 | Not reported | 4 | 26 | Not reported |
| Cohort 3 | 7.6 | Not reported | 0.7 | 14.4 | Not reported |
| Cohort 5 | 13.5 | Not reported | 11 | 16 | Not reported |
| Cohort 6 | 14.1 | Not reported | 8.4 | 96 | Not reported |
| Cohort 7 | 12.3 | Not reported | 4 | 22.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.1
- upper Limit
- 13.1
- value
- 8.1
- group Id
- OG001
- lower Limit
- 4
- upper Limit
- 26
- value
- 7
- group Id
- OG002
- lower Limit
- 0.7
- upper Limit
- 14.4
- value
- 7.6
- group Id
- OG004
- lower Limit
- 11
- upper Limit
- 16
- value
- 13.5
- group Id
- OG005
- lower Limit
- 8.4
- upper Limit
- 96
- value
- 14.1
- group Id
- OG006
- lower Limit
- 4
- upper Limit
- 22.3
- value
- 12.3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 6
- group Id
- OG006
- value
- 6
- units
- Participants
- description
- Progression is defined using RECIST V1.1 - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
- dispersion Type
- Full Range
- groups
- description
- Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG000
- title
- Cohort 1
- description
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG001
- title
- Cohort 2
- description
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG002
- title
- Cohort 3
- description
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG003
- title
- Cohort 4
- description
- Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG004
- title
- Cohort 5
- description
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG005
- title
- Cohort 6
- description
- Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- id
- OG006
- title
- Cohort 7
- param Type
- MEDIAN
- population Description
- Cohort 4 was permanently closed.
- reporting Status
- POSTED
- time Frame
- 7 years
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice