Trial · NCT03493451
Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
NCT03493451, Phase 2, Completed, BeiGene; results first posted 2022-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms. Trials, record NCT03493451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03493451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms
- NCT number
- NCT03493451
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- BeiGene
- Conditions
Peripheral T Cell Lymphoma, PTCL, Extranodal NK/T-cell Lymphoma, Extranodal NK/T-cell Lymphoma, Nasal Type, Extranodal NK T Cell Lymphoma, Extranodal NK T Cell Lymphoma, Nasal, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Angioimmunoblastic T-Cell Lymphoma Recurrent, Angioimmunoblastic T-Cell Lymphoma Refractory, Peripheral T-cell Lymphoma NOS, Peripheral T-Cell Lymphoma, Not Otherwise Specified, Peripheral T-Cell Lymphoma Refractory, Anaplastic Large Cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Positive, Anaplastic Large Cell Lymphoma, ALK-negative, ALK-negative Anaplastic Large Cell Lymphoma, ALK-Positive Anaplastic Large Cell Lymphoma, Cutaneous T-cell Lymphoma
- Interventions
- Tislelizumab
- First posted
- 2018-04-10
- Last updated
- 2024-10-26
- Other registries' IDs
- eudract:2017-003700-44
- Results first posted
- 2022-05-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to approximately 3 years and 1 week | ORR is defined as the percentage of participants achieving a best overall response of complete response or partial response as determined by the investigator using Lugano criteria with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification for cohorts 1 and 2 and International Society for Cutaneous Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) guidelines for cohort 3. |
| Secondary | Duration of Response (DOR) | Up to approximately 3 years and 1 week | DOR defined as the time from the first determination of an objective response until progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3. |
| Secondary | Progression-free Survival (PFS) | Up to approximately 3 years and 1 week | PFS is defined as the time from first study drug administration to the date of disease progression or death, whichever occurs first, as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3. |
| Secondary | Overall Survival (OS) | Up to approximately 3 years and 1 week | OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2. |
| Secondary | Complete Response Rate (CRR) | Up to approximately 3 years and 1 week | 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. |
| Secondary | Time to Response (TTR) | Up to approximately 3 years and 1 week | Time to response defined as the time from first study drug administration to the time the response criteria (complete response or partial response) are first met as assessed by the investigator using Lugano criteria with LYRIC modification for cohorts 1 and 2 and ISCL/EORTC guidelines for cohort 3. |
| Secondary | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week) | Mean change from baseline at safety follow-up visit in EQ-5D-5L visual analogue score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' An increasing score indicates improvements from baseline. |
| Secondary | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week) | Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes global health status and quality of life questions related to their overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status. |
| Secondary | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week) | Mean change from baseline at safety follow-up visit in EORTC QLQ-C30 Fatigue score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients and includes questions related to fatigue symptoms in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Answers are converted to a score of 0 to 100, with a higher score indicating improved health status. |
| Secondary | Number of Participants With Adverse Events | Up to approximately 3 years and 1 week | Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically relevant changes in laboratory tests, physical examination, electrocardiogram, and vital signs |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug; Duration of response was summarized for responders (participants who achieved a partial or complete response). | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug | Months | MEDIAN |
| SECONDARY | Complete Response Rate (CRR) | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug | Percentage of participants | NUMBER |
| SECONDARY | Time to Response (TTR) | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug; Time to response was summarized for responders (participants who achieved a partial or complete response). | Months | MEDIAN |
| SECONDARY | Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score | Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week) | Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire. | Score on a scale | MEAN |
| SECONDARY | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score | Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week) | Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire. | Score on a scale | MEAN |
| SECONDARY | Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score | Baseline and on Day 1 in Cycles 5, 9, 13, 17, 21, 25, 29, and 33 (21 days per cycle) and safety follow-up visit (up to 30 days after end of treatment; up to approximately 3 years and 1 week) | Safety analysis set includes all participants who received at least one dose of study drug. The number analyzed represents participants who completed the questionnaire. | Score on a scale | MEAN |
| SECONDARY | Number of Participants With Adverse Events | Up to approximately 3 years and 1 week | Safety analysis set includes all participants who received at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | Cohort 1: ENKTL | 31.8 | 95% Confidence Interval 13.9 to 54.9 | Percentage of participants | |
| Overall Response Rate (ORR) | Cohort 2: PTCL-NOS, AITL, and ALCL | 20.5 | 95% Confidence Interval 9.8 to 35.3 | Percentage of participants | |
| Overall Response Rate (ORR) | Cohort 3: MF and SS | 45.5 | 95% Confidence Interval 16.7 to 76.6 | Percentage of participants | |
| Duration of Response (DOR) | Cohort 1: ENKTL | NA | 95% Confidence Interval 2.66 to NA | Months | |
| Duration of Response (DOR) | Cohort 2: PTCL-NOS, AITL, and ALCL | 8.2 | 95% Confidence Interval 2.50 to NA | Months | |
| Duration of Response (DOR) | Cohort 3: MF and SS | 11.3 | 95% Confidence Interval 2.76 to 11.30 | Months | |
| Progression-free Survival (PFS) | Cohort 1: ENKTL | 2.7 | 95% Confidence Interval 1.45 to 5.32 | Months | |
| Progression-free Survival (PFS) | Cohort 2: PTCL-NOS, AITL, and ALCL | 2.7 | 95% Confidence Interval 2.56 to 4.76 | Months | |
| Progression-free Survival (PFS) | Cohort 3: MF and SS | 16.8 | 95% Confidence Interval 2.60 to 16.82 | Months | |
| Overall Survival (OS) | Cohort 1: ENKTL | 8.8 | 95% Confidence Interval 3.25 to NA | Months |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: ENKTL | 22 | |
| Overall Study | STARTED | Cohort 2: PTCL-NOS, AITL, and ALCL | 44 | |
| Overall Study | STARTED | Cohort 3: MF and SS | 11 | |
| Overall Study | COMPLETED | Cohort 1: ENKTL | 0 | |
| Overall Study | COMPLETED | Cohort 2: PTCL-NOS, AITL, and ALCL | 0 | |
| Overall Study | COMPLETED | Cohort 3: MF and SS | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1: ENKTL | 22 | |
| Overall Study | NOT COMPLETED | Cohort 2: PTCL-NOS, AITL, and ALCL | 44 | |
| Overall Study | NOT COMPLETED | Cohort 3: MF and SS | 11 |
Source ClinicalTrials.gov
Adverse events609
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: ENKTL | 6 | 22 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: PTCL-NOS, AITL, and ALCL | 7 | 44 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3: MF and SS | 0 | 11 | 0 |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 1: ENKTL | 0 | 22 | 0 |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 2: PTCL-NOS, AITL, and ALCL | 2 | 44 | 4 |
| other | Lymph node pain | Blood and lymphatic system disorders | Cohort 3: MF and SS | 0 | 11 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 1: ENKTL | 0 | 22 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 2: PTCL-NOS, AITL, and ALCL | 2 | 44 | 4 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cohort 3: MF and SS | 0 | 11 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: ENKTL | 0 | 22 | 0 |
1 to 10 of 609Source ClinicalTrials.gov
See all 609 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: ENKTL | 11 | 22 |
| Total, all-cause mortality | Cohort 2: PTCL-NOS, AITL, and ALCL | 26 | 44 |
| Total, all-cause mortality | Cohort 3: MF and SS | 3 | 11 |
| Total, other adverse events | Cohort 1: ENKTL | 21 | 22 |
| Total, other adverse events | Cohort 2: PTCL-NOS, AITL, and ALCL | 39 | 44 |
| Total, other adverse events | Cohort 3: MF and SS | 10 | 11 |
| Total, serious adverse events | Cohort 1: ENKTL | 9 | 22 |
| Total, serious adverse events | Cohort 2: PTCL-NOS, AITL, and ALCL | 21 | 44 |
| Total, serious adverse events | Cohort 3: MF and SS | 5 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37276067 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03493451
GET https://conductscience.org/api/trials/v1/NCT03493451/results?page=2