TriangleNCT02303821 · OUTCOME
Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy
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 Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
What was measured
MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.
Analysis population: Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period.
Groups in this outcome
Phase 2: B-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
Phase 2: T-cell (20/56 mg/m^2)
Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
| Group | Source count |
|---|---|
| Phase 2: B-cell (20/56 mg/m^2) | 25 |
| Phase 2: T-cell (20/56 mg/m^2) | 20 |
Reported measurements
Percentage of Participants Achieving MRD <10-³ Cells
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: B-cell (20/56 mg/m^2) | 16.0 | Not reported | 4.5 | 36.1 | Not reported |
| Phase 2: T-cell (20/56 mg/m^2) | 20.0 | Not reported | 5.7 | 43.7 | Not reported |
Percentage of Participants Achieving MRD <10-⁴ Cells
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: B-cell (20/56 mg/m^2) | 16.0 | Not reported | 4.5 | 36.1 | Not reported |
| Phase 2: T-cell (20/56 mg/m^2) | 20.0 | Not reported | 5.7 | 43.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 36.1
- value
- 16.0
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- 43.7
- value
- 20.0
- title
- Percentage of Participants Achieving MRD <10-³ Cells
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 36.1
- value
- 16.0
- group Id
- OG001
- lower Limit
- 5.7
- upper Limit
- 43.7
- value
- 20.0
- title
- Percentage of Participants Achieving MRD <10-⁴ Cells
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- MRD was defined as the number of leukemia cells that remained in a participant's body after treatment. MRD was measured with NGS.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Eligible participants with relapsed or refractory ALL (B-cell, after having received a targeted B-cell therapy) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
- id
- OG000
- title
- Phase 2: B-cell (20/56 mg/m^2)
- description
- Eligible participants with relapsed or refractory ALL (T-cell) were treated with VXLD plus carfilzomib 20/56 mg/m\^2 for 1 cycle (induction), followed by assessment of treatment response. Participants who did not show progression during induction underwent a bone marrow and extramedullary disease evaluation after completion of induction therapy. Participants without disease progression after induction could at the investigator's discretion, be treated with 1 28-day consolidation cycle of BFM therapy (cyclophosphamide, cytarabine, 6-mercaptopurine, PEG-asparaginase, vincristine), and IT therapy plus carfilzomib.
- id
- OG001
- title
- Phase 2: T-cell (20/56 mg/m^2)
- param Type
- NUMBER
- population Description
- Phase 2 Consolidation Safety Analysis Set: All participants who started the consolidation cycle and received at least 1 dose of study treatment during the consolidation period.
- reporting Status
- POSTED
- time Frame
- Up to Day 100 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants] + 28-day cycle of consolidation therapy + + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
- title
- Phase 2: Percentage of Participants Achieving MRD Status of <10-³ and <10-⁴ Cells in Participants With CRi or Better Status After Consolidation Therapy
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice