TriangleNCT03590574 · OUTCOME
Evaluate Overall Survival (OS) Following Treatment With AUTO4.
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
- Up to 24 months
What was measured
OS was defined as the time from the first treatment of AUTO4 to death due to any cause. Patients who had not died prior to data cut-off or database finalization were censored at the last contact date. Patients who received SCT after AUTO4 infusion were ignored in the main analysis.
Analysis population: Data for OS were pooled for analysis because the number of patients was \<5 for all of the groups and the intended reverse Kaplan-Meier model cannot be built with such a small sample size
Groups in this outcome
All Treated Patients Evaluable for OS
All uncensored patients who received an infusion of AUTO4.
Phase I Dose Escalation - Cohort 1
Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation - Cohort 2
Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation - Cohort 3
Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation - Cohort 4
Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
| Group | Source count |
|---|---|
| All Treated Patients Evaluable for OS | 15 |
| Phase I Dose Escalation - Cohort 1 | 3 |
| Phase I Dose Escalation - Cohort 2 | 2 |
| Phase I Dose Escalation - Cohort 3 | 1 |
| Phase I Dose Escalation - Cohort 4 | 4 |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 1 |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 3 |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated Patients Evaluable for OS | NA | Not reported | NA | NA | The median and associated confidence intervals were not reached due to insufficient number of participants with events. |
| Phase I Dose Escalation - Cohort 1 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
| Phase I Dose Escalation - Cohort 2 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
| Phase I Dose Escalation - Cohort 3 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
| Phase I Dose Escalation - Cohort 4 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5 | NA | Not reported | NA | NA | The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and associated confidence intervals were not reached due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG006
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group with events.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 1
- units
- Participants
- description
- OS was defined as the time from the first treatment of AUTO4 to death due to any cause. Patients who had not died prior to data cut-off or database finalization were censored at the last contact date. Patients who received SCT after AUTO4 infusion were ignored in the main analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All uncensored patients who received an infusion of AUTO4.
- id
- OG000
- title
- All Treated Patients Evaluable for OS
- description
- Patients received 25x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG001
- title
- Phase I Dose Escalation - Cohort 1
- description
- Patients received 75x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG002
- title
- Phase I Dose Escalation - Cohort 2
- description
- Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG003
- title
- Phase I Dose Escalation - Cohort 3
- description
- Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG004
- title
- Phase I Dose Escalation - Cohort 4
- description
- Patients received 225x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG005
- title
- Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3
- description
- Patients received 450x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG006
- title
- Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4
- description
- Patients received 900x10\^6 RQR8/aTRBC1 CAR T-positive cells
- id
- OG007
- title
- Phase I Dose Escalation With Modified Manufacturing Process - Cohort 5
- param Type
- MEDIAN
- population Description
- Data for OS were pooled for analysis because the number of patients was \<5 for all of the groups and the intended reverse Kaplan-Meier model cannot be built with such a small sample size
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Evaluate Overall Survival (OS) Following Treatment With AUTO4.
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice