TriangleNCT03575351 · OUTCOME
Overall Survival (OS)
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 time of death due to any cause (Up to 36 months)
What was measured
Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.
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 | NA | Not reported | 18.2 | NA | Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates. |
| Liso-cel Arm | NA | Not reported | 42.8 | 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
- comment
- Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.
- group Id
- OG000
- lower Limit
- 18.2
- upper Limit
- NA
- value
- NA
- comment
- Median and upper limit not calculated due to insufficient number of events per Kaplan-Meier product-limit estimates.
- group Id
- OG001
- lower Limit
- 42.8
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 92
- group Id
- OG001
- value
- 92
- units
- Participants
- description
- Overall Survival (OS) is defined as the time from randomization to death due to any cause. Estimates of time to event are from Kaplan-Meier product-limit estimates.
- 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 time of death due to any cause (Up to 36 months)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice