TriangleNCT03912064 · OUTCOME
Incidence of Chronic GVHD Rates
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 92
What was measured
Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92.
Groups in this outcome
Dose Level: 0
1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
Dose Level: 1
3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
Dose Level: 2
10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
| Group | Source count |
|---|---|
| Dose Level: 0 | 18 |
| Dose Level: 1 | 6 |
| Dose Level: 2 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level: 0 | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Level: 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level: 2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 1
- units
- Participants
- description
- Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92.
- groups
- description
- 1 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
- id
- OG000
- title
- Dose Level: 0
- description
- 3 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
- id
- OG001
- title
- Dose Level: 1
- description
- 10 mg/kg of Ipilimumab and 3x10\^7 CD3+ cells/kg of CD25/Treg-depleted DLI will be administered intravenously over 90 ± 10 minutes after the DLI product observation period is completed, and dosing will continue in 3-week intervals for 4 cycles, unless unacceptable toxicity or symptomatic disease progression occurs.
- id
- OG002
- title
- Dose Level: 2
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Day 92
- title
- Incidence of Chronic GVHD Rates
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice