TriangleNCT05787496 · OUTCOME
To Evaluate the Clinical Benefit of NC525 by Assessing 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
- Time until death, up to 23 months
What was measured
Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
Analysis population: Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK. The analysis population includes all participants who received at least one dose of NC525 in each dose cohort. All participants were included in the analysis regardless of whether they experienced the event (death). Overall survival was analyzed using the Kaplan-Meier method.
Groups in this outcome
2mg/kg NC525
Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
2.5mg/kg NC525
Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
4.5mg/kg NC525
Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
9mg/kg NC525
Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
13.5mg/kg NC525
Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
18mg/kg NC525
Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
| Group | Source count |
|---|---|
| 2mg/kg NC525 | 3 |
| 2.5mg/kg NC525 | 4 |
| 4.5mg/kg NC525 | 3 |
| 9mg/kg NC525 | 9 |
| 13.5mg/kg NC525 | 2 |
| 18mg/kg NC525 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 2mg/kg NC525 | 3.8 | Not reported | 3.6 | NA | The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit. |
| 2.5mg/kg NC525 | 6 | Not reported | 3.1 | NA | The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit. |
| 4.5mg/kg NC525 | 6.5 | Not reported | 2.5 | NA | The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit. |
| 9mg/kg NC525 | 4.1 | Not reported | 1.1 | 7.7 | Not reported |
| 13.5mg/kg NC525 | NA | Not reported | 1.5 | NA | The median overall survival and corresponding upper confidence interval could not be estimated due to the very small sample size and insufficient information to support Kaplan-Meier estimation. |
| 18mg/kg NC525 | 3.1 | Not reported | 2.6 | NA | The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
- group Id
- OG000
- lower Limit
- 3.6
- upper Limit
- NA
- value
- 3.8
- comment
- The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
- group Id
- OG001
- lower Limit
- 3.1
- upper Limit
- NA
- value
- 6
- comment
- The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
- group Id
- OG002
- lower Limit
- 2.5
- upper Limit
- NA
- value
- 6.5
- group Id
- OG003
- lower Limit
- 1.1
- upper Limit
- 7.7
- value
- 4.1
- comment
- The median overall survival and corresponding upper confidence interval could not be estimated due to the very small sample size and insufficient information to support Kaplan-Meier estimation.
- group Id
- OG004
- lower Limit
- 1.5
- upper Limit
- NA
- value
- NA
- comment
- The upper bound of the 95% confidence interval for the median overall survival could not be estimated due to the very small sample size and limited number of participants in this cohort. Although all participants experienced the event, the Kaplan-Meier variance estimate was insufficient to calculate an upper confidence limit.
- group Id
- OG005
- lower Limit
- 2.6
- upper Limit
- NA
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- Disease Assessments will be performed using the European Leukemia Net (ELN) Guidelines for the ELN Outcome Measures.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG000
- title
- 2mg/kg NC525
- description
- Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG001
- title
- 2.5mg/kg NC525
- description
- Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG002
- title
- 4.5mg/kg NC525
- description
- Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG003
- title
- 9mg/kg NC525
- description
- Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG004
- title
- 13.5mg/kg NC525
- description
- Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- OG005
- title
- 18mg/kg NC525
- param Type
- MEDIAN
- population Description
- Full Analysis Set (FAS): The FAS includes all subjects enrolled in the study who received at least one full dose of NC525. The FAS will be used for summaries and analyses of all data that are not safety or PK. The analysis population includes all participants who received at least one dose of NC525 in each dose cohort. All participants were included in the analysis regardless of whether they experienced the event (death). Overall survival was analyzed using the Kaplan-Meier method.
- reporting Status
- POSTED
- time Frame
- Time until death, up to 23 months
- title
- To Evaluate the Clinical Benefit of NC525 by Assessing Overall Survival (OS).
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice