TriangleNCT03493451 · OUTCOME
Complete Response Rate (CRR)
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 approximately 3 years and 1 week
What was measured
CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
Analysis population: Safety analysis set includes all participants who received at least one dose of study drug
Groups in this outcome
Cohort 1: ENKTL
Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Cohort 2: PTCL-NOS, AITL, and ALCL
Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Cohort 3: MF and SS
Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
| Group | Source count |
|---|---|
| Cohort 1: ENKTL | 22 |
| Cohort 2: PTCL-NOS, AITL, and ALCL | 44 |
| Cohort 3: MF and SS | 11 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1: ENKTL | 18.2 | Not reported | 5.2 | 40.3 | Not reported |
| Cohort 2: PTCL-NOS, AITL, and ALCL | 9.1 | Not reported | 2.5 | 21.7 | Not reported |
| Cohort 3: MF and SS | 9.1 | Not reported | 0.2 | 41.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.2
- upper Limit
- 40.3
- value
- 18.2
- group Id
- OG001
- lower Limit
- 2.5
- upper Limit
- 21.7
- value
- 9.1
- group Id
- OG002
- lower Limit
- 0.2
- upper Limit
- 41.3
- value
- 9.1
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 44
- group Id
- OG002
- value
- 11
- units
- Participants
- description
- CRR is defined as the percentage of participants who achieve complete response or complete metabolic response as best overall response as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG000
- title
- Cohort 1: ENKTL
- description
- Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG001
- title
- Cohort 2: PTCL-NOS, AITL, and ALCL
- description
- Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
- id
- OG002
- title
- Cohort 3: MF and SS
- param Type
- NUMBER
- population Description
- Safety analysis set includes all participants who received at least one dose of study drug
- reporting Status
- POSTED
- time Frame
- Up to approximately 3 years and 1 week
- title
- Complete Response Rate (CRR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice