TriangleNCT03912064 · OUTCOME
Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi)
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 43 (6 weeks)
What was measured
Complete remission will be evaluated for each disease, along with duration of complete remission. AML morphological complete remission can be found in Appendix E (E.1.1.), and Relapse from CR/CRi is in E.1.3. MDS/MPN complete remission criteria is found in Appendix F (F.1.1), and criteria for relapse is found in F.1.5.
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 | 8 | Not reported | Not reported | Not reported | Not reported |
| Dose Level: 1 | 4 | 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
- 8
- group Id
- OG001
- value
- 4
- 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
- Complete remission will be evaluated for each disease, along with duration of complete remission. AML morphological complete remission can be found in Appendix E (E.1.1.), and Relapse from CR/CRi is in E.1.3. MDS/MPN complete remission criteria is found in Appendix F (F.1.1), and criteria for relapse is found in F.1.5.
- 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 43 (6 weeks)
- title
- Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice