TriangleNCT02303821 · OUTCOME
Phase 2: 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
- Up to approximately 2 years
What was measured
OS was defined as time from initiation of therapy until death from any cause. Data was IPTW adjusted. Medians were estimated using the KM method.
Analysis population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
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) | 61 |
| Phase 2: T-cell (20/56 mg/m^2) | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: B-cell (20/56 mg/m^2) | 5.23 | Not reported | 2.93 | 9.24 | Not reported |
| Phase 2: T-cell (20/56 mg/m^2) | 4.51 | Not reported | 3.49 | 9.18 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- The objective of this endpoint was to compare the OS in study 20140106 with OS in an external control arm selected from an observational study (Amgen 20180065). The median OS in months for the B-Cell participants in the external control arm was 8.59 (95% CI: 5.26, 10.59) with a treatment difference hazard ratio of 1.245 (95% CI: 0.805, 1.927). For the T-Cell participants the median OS in months was 7.04 (95% CI: 7.04, NE) with a treatment difference hazard ratio of 1.040 (95% CI: 0.641, 1.688).
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.93
- upper Limit
- 9.24
- value
- 5.23
- group Id
- OG001
- lower Limit
- 3.49
- upper Limit
- 9.18
- value
- 4.51
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 44
- units
- Participants
- description
- OS was defined as time from initiation of therapy until death from any cause. Data was IPTW adjusted. Medians were estimated using the KM method.
- 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
- MEDIAN
- population Description
- Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years
- title
- Phase 2: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice