TriangleNCT00002663 · OUTCOME
Time to Response (TTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From Day 1 through 251.1 months after Day 1 dose
What was measured
The TTR was defined as the time from the date of the first dose of tabelecleucel or EBV-CTLs to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR was defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs; and a PR was defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR was defined as clearance of EBV without subsequent development of EBV+ LPD; and PR was defined as at least a 10-fold decrease in EBV DNA levels.
Analysis population: Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Participants who achieved CR or PR were analyzed for this outcome measure. Results from arms with \<= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
Groups in this outcome
EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ LMS (Tab-cel Only)
Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
EBV+ Viremia (EBV-CTLs Only)
Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only) | 7 |
| EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only) | 2 |
| EBV+ LMS (Tab-cel Only) | 0 |
| EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only) | 10 |
| EBV+ Viremia (EBV-CTLs Only) | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only) | 1.18 | Not reported | 0.8 | 2.4 | Not reported |
| EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only) | 6.74 | Not reported | 3.1 | 10.4 | Not reported |
| EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only) | 1.45 | Not reported | 0.6 | 5.1 | Not reported |
| EBV+ Viremia (EBV-CTLs Only) | 1.22 | Not reported | 1.1 | 1.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- 2.4
- value
- 1.18
- group Id
- OG001
- lower Limit
- 3.1
- upper Limit
- 10.4
- value
- 6.74
- group Id
- OG003
- lower Limit
- 0.6
- upper Limit
- 5.1
- value
- 1.45
- group Id
- OG004
- lower Limit
- 1.1
- upper Limit
- 1.4
- value
- 1.22
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 4
- units
- Participants
- description
- The TTR was defined as the time from the date of the first dose of tabelecleucel or EBV-CTLs to the date of a PR or CR, whichever occurred first. For participants with clinically and/or radiologically evident EBV LPD or malignancies, CR was defined as complete resolution of all clinical and radiologic evidence of lymphoma, confirmed by biopsy of the affected tissues when indicated, lasting for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs; and a PR was defined as a 50 % or greater reduction in the size of all lymphomatous lesions as determined by CT or MRI scan measurements of tumor volume, which was maintained for at least 3 weeks following completion of a cycle of tabelecleucel or EBV-CTLs. For participants without clinically and/or radiologically evident tumors with increasing levels of EBV DNA, CR was defined as clearance of EBV without subsequent development of EBV+ LPD; and PR was defined as at least a 10-fold decrease in EBV DNA levels.
- dispersion Type
- Full Range
- groups
- description
- Participants with EBV+ PTLD following HCT who were R/R to rituximab received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- EBV+ PTLD-HCT R/R Rituximab (Tab-cel Only)
- description
- Participants with EBV+PTLD following SOT who were R/R to rituximab and chemotherapy received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- EBV+ PTLD-SOT R/R Rituximab + Chemo (Tab-cel Only)
- description
- Participants with EBV+ following LMS received IV infusion of tabelecleucel on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG002
- title
- EBV+ LMS (Tab-cel Only)
- description
- Participants with EBV+PTLD following HCT who were R/R to rituximab or rituximab naive received donor-derived EBV-CTL on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG003
- title
- EBV+ PTLD-HCT R/R Rituximab (EBV-CTLs Only)
- description
- Participants with EBV+ following viremia received donor-derived EBV-CTLs on Days 1, 8, and 15 and were observed for 3 weeks. After the observation period, additional courses (2 courses) may have been provided in the absence of disease progression or unacceptable toxicity.
- id
- OG004
- title
- EBV+ Viremia (EBV-CTLs Only)
- param Type
- MEDIAN
- population Description
- Full analysis set included all participants who received at least one dose of study treatment (tabelecleucel or EBV-CTLs). Participants who achieved CR or PR were analyzed for this outcome measure. Results from arms with \<= 3 participants (as shown in the participant flow) are excluded due to the low numbers of participants; these low numbers pose a risk for participant re-identification in these rare indications of this single center study.
- reporting Status
- POSTED
- time Frame
- From Day 1 through 251.1 months after Day 1 dose
- title
- Time to Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice