TriangleNCT02663518 · OUTCOME
Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
What was measured
ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL).
Analysis population: Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 2: Aggressive B-cell Lymphoma (ABCL)
Participants with ABCL who received study drug in Part 2.
Part 2: Hodgkin Lymphoma (HL)
Participants with HL who received study drug in Part 2.
Part 2: Indolent B-cell Lymphoma (IBCL)
Participants with IBCL who received study drug in Part 2.
Part 2: Classical Hodgkin's Lymphoma (cHL)
Participants with cHL who received nivolumab combination in Part 2.
Part 2: CD20-positive Malignancies
Participants with CD20-positive malignancies who received rituximab combination in Part 2.
Parts 2 and 3: Peripheral T-cell Lymphoma (PTCL)
Participants with PTCL who received study drug in Parts 2 and 3.
Parts 2 and 3: T-cell Lymphoma (TCL)
Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
| Group | Source count |
|---|---|
| Part 2: Aggressive B-cell Lymphoma (ABCL) | 5 |
| Part 2: Hodgkin Lymphoma (HL) | 13 |
| Part 2: Indolent B-cell Lymphoma (IBCL) | 5 |
| Part 2: Classical Hodgkin's Lymphoma (cHL) | 11 |
| Part 2: CD20-positive Malignancies | 40 |
| Parts 2 and 3: Peripheral T-cell Lymphoma (PTCL) | 21 |
| Parts 2 and 3: T-cell Lymphoma (TCL) | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: Aggressive B-cell Lymphoma (ABCL) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Hodgkin Lymphoma (HL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Indolent B-cell Lymphoma (IBCL) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Classical Hodgkin's Lymphoma (cHL) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2: CD20-positive Malignancies | 9 | Not reported | Not reported | Not reported | Not reported |
| Parts 2 and 3: Peripheral T-cell Lymphoma (PTCL) | 3 | Not reported | Not reported | Not reported | Not reported |
| Parts 2 and 3: T-cell Lymphoma (TCL) | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 40
- group Id
- OG005
- value
- 21
- group Id
- OG006
- value
- 11
- units
- Participants
- description
- ORR is presented in this outcome measure as number of responders. Responders were those who had complete remission and partial remission. Lugano classification (Cheson et al., 2014) and refinement (Cheson et al., 2016) were used for tumor response assessment for lymphomas by computed tomography (CT)-based criteria and complete metabolic response (CMR) or partial metabolic response (PMR) by positron emission tomography (PET-CT) based criteria were used for evaluation. Lymphomas evaluated by Lugano Classification include aggressive B-cell lymphoma (ABCL), Hodgkin's lymphoma (HL), Non-Hodgkin's lymphoma, indolent B-cell lymphoma (IBCL), peripheral T-cell lymphoma (PTCL), and part of T-cell lymphoma (TCL).
- groups
- description
- Participants with ABCL who received study drug in Part 2.
- id
- OG000
- title
- Part 2: Aggressive B-cell Lymphoma (ABCL)
- description
- Participants with HL who received study drug in Part 2.
- id
- OG001
- title
- Part 2: Hodgkin Lymphoma (HL)
- description
- Participants with IBCL who received study drug in Part 2.
- id
- OG002
- title
- Part 2: Indolent B-cell Lymphoma (IBCL)
- description
- Participants with cHL who received nivolumab combination in Part 2.
- id
- OG003
- title
- Part 2: Classical Hodgkin's Lymphoma (cHL)
- description
- Participants with CD20-positive malignancies who received rituximab combination in Part 2.
- id
- OG004
- title
- Part 2: CD20-positive Malignancies
- description
- Participants with PTCL who received study drug in Parts 2 and 3.
- id
- OG005
- title
- Parts 2 and 3: Peripheral T-cell Lymphoma (PTCL)
- description
- Participants with TCL who received study drug and response assessment by Lugano Classification (Cheson 2014/2016) in Parts 2 and 3.
- id
- OG006
- title
- Parts 2 and 3: T-cell Lymphoma (TCL)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Full analysis set included all participants who received at least 1 dose of study treatment. "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From first dose of study till the progressive disease/ death or withdrawal (maximum observation 6 years 10 months)
- title
- Part 2 and 3: Overall Response Rate (ORR) - Lugano Classification (Cheson 2014) and Refinement (Cheson 2016) Disease Indications and Nivolumab/Rituximab Combinations
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice