TriangleNCT04569032 · OUTCOME
ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment
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
- At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
What was measured
ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses.
Analysis population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
Groups in this outcome
CD30 <1% [Central Laboratory Assessment]
Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
CD30 1% to <10% [Central Laboratory Assessment]
Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
| Group | Source count |
|---|---|
| CD30 <1% [Central Laboratory Assessment] | 23 |
| CD30 1% to <10% [Central Laboratory Assessment] | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CD30 <1% [Central Laboratory Assessment] | 57 | Not reported | 34.5 | 76.8 | Not reported |
| CD30 1% to <10% [Central Laboratory Assessment] | 77 | Not reported | 58.9 | 90.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.5
- upper Limit
- 76.8
- value
- 57
- group Id
- OG001
- lower Limit
- 58.9
- upper Limit
- 90.4
- value
- 77
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 31
- units
- Participants
- description
- ORR was defined as the percentage of participants with CR or PR following the completion of study treatment (at EOT) according to the modified Lugano criteria (Cheson 2014). Complete response was defined as complete disappearance of radiologic evidence of disease and PR was defined as at least a 50% decrease in SPD of up to six of the largest dominant nodes or nodal masses.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with \<1% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- OG000
- title
- CD30 <1% [Central Laboratory Assessment]
- description
- Participants with 1% to \<10% CD30 expression (per central laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle. Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
- id
- OG001
- title
- CD30 1% to <10% [Central Laboratory Assessment]
- param Type
- NUMBER
- population Description
- FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Analyses as planned was based on the participants classified based on central laboratory assessment for CD30 expression.
- reporting Status
- POSTED
- time Frame
- At EOT or the first assessment after the last dose of study treatment (prior to long term follow-up or initiation of subsequent anti-cancer therapies); up to 41.91 months
- title
- ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice