TriangleNCT02303821 · OUTCOME
Phase 2: Duration of Remission (DOR)
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
DOR was defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause. CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp) or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count \< 100 000/µL. CRh was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL.
Analysis population: Phase 2: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib. Only participants who achieved CRi or a better remission status were included in the analysis. Data was IPTW adjusted. Medians were estimated using the KM method.
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) | 26 |
| Phase 2: T-cell (20/56 mg/m^2) | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: B-cell (20/56 mg/m^2) | 7.55 | Not reported | 3.42 | 22.20 | Not reported |
| Phase 2: T-cell (20/56 mg/m^2) | 9.01 | Not reported | 2.57 | NA | Upper CI limit not evaluable due to insufficient observations occurring above the median. |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- The DOR in study 20140106 was estimated relative to the DOR in an external control arm selected from an observational study (Amgen 20180065). The median DOR in months in the external control arm was 8.72 (95% CI: 5.07, 32.24) in B-Cell participants. For T-Cell participants the median DOR in months was 5.82 (95% CI: 1.22, 19.80).
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.42
- upper Limit
- 22.20
- value
- 7.55
- comment
- Upper CI limit not evaluable due to insufficient observations occurring above the median.
- group Id
- OG001
- lower Limit
- 2.57
- upper Limit
- NA
- value
- 9.01
- denoms
- counts
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 14
- units
- Participants
- description
- DOR was defined as time from earliest of CR, CRp, CRh, or CRi to relapse or death from any cause. CR was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease. b. Recovery of peripheral counts: - ANC ≥ 1000/µL - Platelet count ≥ 100 000/µL. CRi was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. ANC and platelet counts not fulfilling criteria for CRh, CRp) or CR. CRp was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 1000/µL ii. Platelet count \< 100 000/µL. CRh was defined as: a. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease b. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL.
- 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. Only participants who achieved CRi or a better remission status were included in the analysis. Data was IPTW adjusted. Medians were estimated using the KM method.
- reporting Status
- POSTED
- time Frame
- Up to approximately 2 years
- title
- Phase 2: Duration of Remission (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice