TriangleNCT02303821 · OUTCOME
Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status
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 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
What was measured
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: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. ANC and platelet counts not fulfilling criteria for CR with partial hematologic recovery (CRh), CR without platelet recovery (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: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL. Data was IPTW adjusted.
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) | 42.6 | Not reported | 30.2 | 55.0 | Not reported |
| Phase 2: T-cell (20/56 mg/m^2) | 27.3 | Not reported | 14.1 | 40.4 | 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 rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- The objective of this endpoint was to compare the rate of CRi or better status against an external control arm selected from an observational study (Amgen 20180065). The rate of CRi or better status in the external control arm was 26.3% (95% CI: 15.1, 37.5) for B-Cell participants with treatment difference odds ratio of 2.082 (95% CI: 0.968, 4.477). For T-Cell participants the rate of CRi or better status was 18.6% (95% CI: 7.1, 30.0) with treatment difference odds ratio of 1.646 (95% CI: 0.639. 4.245).
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.2
- upper Limit
- 55.0
- value
- 42.6
- group Id
- OG001
- lower Limit
- 14.1
- upper Limit
- 40.4
- value
- 27.3
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 44
- units
- Participants
- description
- 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: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. ANC and platelet counts not fulfilling criteria for CR with partial hematologic recovery (CRh), CR without platelet recovery (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: 1. Attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease 2. Recovery of peripheral counts: i. ANC ≥ 500/µL but \< 1000/µL ii. Platelet count ≥ 50 000/µL but \< 100 000/µL. Data was IPTW adjusted.
- 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: Participants enrolled in 20140106, in the PAS, who received at least 1 dose of carfilzomib.
- reporting Status
- POSTED
- time Frame
- Up to Day 50 (28-day cycle of induction therapy + recovery window from Day 29 to Day 45 [up to Day 50 for infants])
- title
- Phase 2: Percentage of Participants With CR With Incomplete Hematologic Recovery (CRi) After Induction Therapy or Better Remission Status
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice