TriangleNCT03590574 · OUTCOME
Evaluate Duration of Response (DOR) 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
DOR was defined as the time from the first observed CR or partial response (PR) to documented disease progression or death due to any cause, for patients who were considered as responders. Patients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis. Patients who proceeded to stem cell transplantation (SCT) after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT). Patients who received new non-protocol anticancer therapies other than SCT were censored at the date of last adequate assessment prior to the new therapy. Patients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event. Data for DOR were pooled for analysis because the number of patients was \<5 for all of the groups and the intended model cannot be built with such a small sample size.
Analysis population: Patients who were considered as responders and were not censored were included in the analysis. Data for DOR 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. The intended reverse Kaplan-Meier model could not be built for 1 patient.
Groups in this outcome
All Treated Patients Evaluable for DOR
All patients who received an infusion of AUTO4 who were classified as responders and who were not censored.
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 DOR | 8 |
| Phase I Dose Escalation - Cohort 1 | 1 |
| Phase I Dose Escalation - Cohort 2 | 1 |
| Phase I Dose Escalation - Cohort 3 | 1 |
| Phase I Dose Escalation - Cohort 4 | 4 |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 3 | 0 |
| Phase I Dose Escalation With Modified Manufacturing Process - Cohort 4 | 0 |
| 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 DOR | 4.27 | Not reported | 0.99 | 25.07 | Not reported |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.99
- upper Limit
- 25.07
- value
- 4.27
- comment
- The intended reverse Kaplan-Meier model could not be built with so few patients in the group.
- 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.
- 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.
- 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.
- 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.
- group Id
- OG007
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- units
- Participants
- description
- DOR was defined as the time from the first observed CR or partial response (PR) to documented disease progression or death due to any cause, for patients who were considered as responders. Patients who received protocol specified anti-cancer treatment post AUTO4 infusion were ignored in the main analysis. Patients who proceeded to stem cell transplantation (SCT) after AUTO4 infusion were censored at the time of SCT (including the conditioning regimen for SCT). Patients who received new non-protocol anticancer therapies other than SCT were censored at the date of last adequate assessment prior to the new therapy. Patients who experienced event after missing two or more scheduled disease assessments were censored at the date of last adequate assessment prior to the event. Data for DOR were pooled for analysis because the number of patients was \<5 for all of the groups and the intended model cannot be built with such a small sample size.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients who received an infusion of AUTO4 who were classified as responders and who were not censored.
- id
- OG000
- title
- All Treated Patients Evaluable for DOR
- 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
- Patients who were considered as responders and were not censored were included in the analysis. Data for DOR 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. The intended reverse Kaplan-Meier model could not be built for 1 patient.
- reporting Status
- POSTED
- time Frame
- Up to 24 months
- title
- Evaluate Duration of Response (DOR) Following Treatment With AUTO4.
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice