TriangleNCT03225716 · 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
- Full Range
- Time frame
- Response and progression status evaluated at each cycle day 1, starting at Cycle 2 Day 1 through Cycle 48, and every 12 weeks during follow-up for up to 2 years after end of treatment
What was measured
Time in months until \>25% increase in serum IgM from nadir
Analysis population: Of the 13 participants enrolled, only 1 participant confirmed disease progression during the study period. Median PFS was not reached. The median follow-up time before participants follow-up was terminated for each participant is reported.
Groups in this outcome
Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
* Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
| Group | Source count |
|---|---|
| Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6 | 7 |
| Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6 | 3 |
| Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6 | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6 | 20 | Not reported | 3 | 45 | Not reported |
| Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6 | 43 | Not reported | 35 | 44 | Not reported |
| Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6 | 37 | Not reported | 15 | 42 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 45
- value
- 20
- group Id
- OG001
- lower Limit
- 35
- upper Limit
- 44
- value
- 43
- group Id
- OG002
- lower Limit
- 15
- upper Limit
- 42
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- units
- Participants
- description
- Time in months until \>25% increase in serum IgM from nadir
- dispersion Type
- Full Range
- groups
- description
- * Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
- id
- OG000
- title
- Phase 1 Dose Level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
- description
- * Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
- id
- OG001
- title
- Phase 1 Dose Level 2: Ibrutinib + Ulocuplumab 800 mg Cycle 1 and 1200mg Cycles 2-6
- description
- * Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
- id
- OG002
- title
- Phase 1 Dose Level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
- param Type
- MEDIAN
- population Description
- Of the 13 participants enrolled, only 1 participant confirmed disease progression during the study period. Median PFS was not reached. The median follow-up time before participants follow-up was terminated for each participant is reported.
- reporting Status
- POSTED
- time Frame
- Response and progression status evaluated at each cycle day 1, starting at Cycle 2 Day 1 through Cycle 48, and every 12 weeks during follow-up for up to 2 years after end of treatment
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice