TriangleNCT03548207 · OUTCOME
Phase 1b and Phase 2: 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
- Pre dose (Day 1) up to 45.2 months
What was measured
Progression-free survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of first documented disease progression.
Analysis population: mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Groups in this outcome
Phase 1b (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
Phase 2 (US Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
Phase 2 (Japan Population)
Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
| Group | Source count |
|---|---|
| Phase 1b (US Population) | 29 |
| Phase 2 (US Population) | 68 |
| Phase 2 (Japan Population) | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b (US Population) | NA | Not reported | 16.79 | NA | Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
| Phase 2 (US Population) | NA | Not reported | 24.08 | NA | Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
| Phase 2 (Japan Population) | NA | Not reported | 11.17 | NA | Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 16.79
- upper Limit
- NA
- value
- NA
- comment
- Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 24.08
- upper Limit
- NA
- value
- NA
- comment
- Here, NA signifies that median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG002
- lower Limit
- 11.17
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 68
- group Id
- OG002
- value
- 8
- units
- Participants
- description
- Progression-free survival was defined as the time from the date of the initial infusion of JNJ-68284528 to the date of first documented disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received a conditioning regimen of cyclophosphamide 300 milligrams per meter square (mg/m\^2) intravenous (IV) infusion and fludarabine 30 mg/m\^2 as IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received target dose of JNJ-68284528 0.75\*10\^6 chimeric antigen receptor T (CAR-T) cells per kilogram (cells/kg) (range: 0.5-1.0\*10\^6 CAR-positive viable cells/kg) as IV infusion.
- id
- OG000
- title
- Phase 1b (US Population)
- description
- Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received recommended phase 2 dose (RP2D) dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG001
- title
- Phase 2 (US Population)
- description
- Participants received a conditioning regimen of cyclophosphamide 300 mg/m\^2 IV infusion and fludarabine 30 mg/m\^2 IV infusion daily for 3 days from Day -5 to Day -3. On Day 1, participants received RP2D dose of JNJ-68284528 0.75\*10\^6 CAR positive viable T cells/kg as IV infusion.
- id
- OG002
- title
- Phase 2 (Japan Population)
- param Type
- MEDIAN
- population Description
- mITT analysis set included all participants who received a JNJ-68284528 infusion at the targeted RP2D dose level. Here, N (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Pre dose (Day 1) up to 45.2 months
- title
- Phase 1b and Phase 2: Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice