TriangleNCT03575351 · OUTCOME
Progression-free Survival (PFS)
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
- From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
What was measured
Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
Analysis population: All randomized participants
Groups in this outcome
Standard of Care Arm
3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
Liso-cel Arm
\[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
| Group | Source count |
|---|---|
| Standard of Care Arm | 92 |
| Liso-cel Arm | 92 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard of Care Arm | 6.2 | Not reported | 4.3 | 8.6 | Not reported |
| Liso-cel Arm | NA | Not reported | 12.6 | NA | Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.3
- upper Limit
- 8.6
- value
- 6.2
- comment
- Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.
- group Id
- OG001
- lower Limit
- 12.6
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- Progression-free survival is defined as the time from randomization to progressive disease (PD) or death from any cause, whichever occurs first. Estimates of time to event are from Kaplan-Meier product-limit estimates. PD: LDi \> 1.5 cm, increase by ≥ 50% from PPD nadir, an increase in LDi or SDi from nadir, 0.5 cm for lesions ≤ 2 cm, 1.0 cm for lesions \> 2 cm. Progressive metabolic disease: Score 4 or 5 with an increase in the intensity of uptake from baseline and/or new FDG-avid.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 3 cycles of standard of care (SOC) salvage therapy (R-DHAP, R-ICE and R-GDP) per physician's choice. Participants responding to SOC are expected to undergo high dose chemotherapy (HDCT) and hematopoietic stem cell transplant (HSCT). If requested by the investigator, participants may be allowed to receive JCAR017 upon meeting progression, relapse, or suboptimal response. 1 cycle = 3 weeks
- id
- OG000
- title
- Standard of Care Arm
- description
- \[Lymphodepleting chemotherapy (LDC)\] Fludarabine IV (30 mg/m\^2/day for 3 days) and cyclophosphamide IV (300 mg/m\^2/day for 3 days) followed by JCAR017 IV infusion at a dose of 100 x 10\^6 JCAR017-positive viable transduced T cells (CAR+ T cells) on Day 29 (2 to 7 days after completion of LD chemotherapy)
- id
- OG001
- title
- Liso-cel Arm
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to progression, or death from any cause, whichever occurs first (Up to 36 months)
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice