TriangleNCT02303821 · OUTCOME
Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day29)
What was measured
MRD was defined as the quantification of residual lymphoblast in the blood. Assessed by next generation sequencing (NGS).
Analysis population: Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.
Groups in this outcome
Phase 1b: Dose Escalation 1 (20 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
| Group | Source count |
|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 5 |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 3 |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 7 |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 4 |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 10 |
Reported measurements
Achieved MRD status < 10^3 lymphoblasts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 14.3 | Not reported | 0.4 | 57.9 | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 25.0 | Not reported | 0.6 | 80.6 | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
Achieved MRD status < 10^4 lymphoblasts
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1b: Dose Escalation 1 (20 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
| Phase 1b: Dose Escalation 1 (20/27 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
| Phase 1b: Dose Escalation 2 (20/27 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
| Phase 1b: Dose Escalation 2 (20/36 mg/m^2) | 14.3 | Not reported | 0.4 | 57.9 | Not reported |
| Phase 1b: Dose Escalation 2 (20/45 mg/m^2) | 25.0 | Not reported | 0.6 | 80.6 | Not reported |
| Phase 1b: Dose Escalation 2 (20/56 mg/m^2) | 0 | Not reported | NA | NA | Dispersion was not estimable as 0 participants achieved MRD status |
Complete source fields
- classes
- categories
- measurements
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 57.9
- value
- 14.3
- group Id
- OG004
- lower Limit
- 0.6
- upper Limit
- 80.6
- value
- 25.0
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- title
- Achieved MRD status < 10^3 lymphoblasts
- categories
- measurements
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 57.9
- value
- 14.3
- group Id
- OG004
- lower Limit
- 0.6
- upper Limit
- 80.6
- value
- 25.0
- comment
- Dispersion was not estimable as 0 participants achieved MRD status
- group Id
- OG005
- lower Limit
- NA
- upper Limit
- NA
- value
- 0
- title
- Achieved MRD status < 10^4 lymphoblasts
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 10
- units
- Participants
- description
- MRD was defined as the quantification of residual lymphoblast in the blood. Assessed by next generation sequencing (NGS).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG000
- title
- Phase 1b: Dose Escalation 1 (20 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG001
- title
- Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG002
- title
- Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG003
- title
- Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG004
- title
- Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
- description
- Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
- id
- OG005
- title
- Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
- param Type
- NUMBER
- population Description
- Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.
- reporting Status
- POSTED
- time Frame
- Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day29)
- title
- Phase 1b: Percentage of Participants Achieving Minimal Residual Disease (MRD) Status of <10-³ and <10-⁴ Lymphoblasts at the End of Induction Cycle
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice