A Phase 2 interventional study of Tislelizumab in Peripheral T Cell Lymphoma, PTCL and Extranodal NK/T-cell Lymphoma, sponsored by BeiGene. Completed at 24 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by BeiGene · Phase 2, Interventional, and Treatment
This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:
Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).
607 studies on the registry are indexed under Lymphoma, T-Cell, Peripheral; 133 are open to participants now.
This study's enrollment of 77 is above the median of 39 across 529 interventional studies indexed under Lymphoma, T-Cell, Peripheral.
Browse Lymphoma, T-Cell, Peripheral studies →BeiGene is the lead sponsor of 125 studies on the registry; 2 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 32 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Key Exclusion Criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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)
Drug: Tislelizumab
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)
Drug: Tislelizumab
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)
Drug: Tislelizumab
Administered intravenously
Also known as: BGB-A317
Overall Response Rate (ORR)
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.
Time frame: Up to approximately 3 years and 1 week
Duration of Response (DOR)
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.
Time frame: Up to approximately 3 years and 1 week
Progression-free Survival (PFS)
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.
Time frame: Up to approximately 3 years and 1 week
Overall Survival (OS)
OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
Time frame: Up to approximately 3 years and 1 week
Complete Response Rate (CRR)
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.
Time frame: Up to approximately 3 years and 1 week
Time to Response (TTR)
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.
Time frame: Up to approximately 3 years and 1 week
Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score
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.
Time frame: 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)
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score
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.
Time frame: 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)
Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
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.
Time frame: 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)
Number of Participants With Adverse Events
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
Time frame: Up to approximately 3 years and 1 week
Participants were enrolled from study centers in Canada, China, France, Italy, and Taiwan, China.
| Milestone | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Started | 22 | 44 | 11 |
| Completed | 0 | 0 | 0 |
| Not completed | 22 | 44 | 11 |
| Withdrew: Death | 11 | 26 | 3 |
| Withdrew: Lost to follow-up | 1 | 4 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 |
| Withdrew: Progressive disease | 1 | 0 | 0 |
| Withdrew: Transferred to long term extension study | 8 | 13 | 5 |
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.
| Percentage of participants | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Overall Response Rate (ORR) | 31.8 (13.9 to 54.9) | 20.5 (9.8 to 35.3) | 45.5 (16.7 to 76.6) |
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.
| Months | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Duration of Response (DOR) | NA (2.66 to NA) | 8.2 (2.50 to NA) | 11.3 (2.76 to 11.30) |
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.
| Months | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Progression-free Survival (PFS) | 2.7 (1.45 to 5.32) | 2.7 (2.56 to 4.76) | 16.8 (2.60 to 16.82) |
OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
| Months | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL |
|---|---|---|
| Overall Survival (OS) | 8.8 (3.25 to NA) | 13.3 (7.66 to 26.22) |
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.
| Percentage of participants | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Complete Response Rate (CRR) | 18.2 (5.2 to 40.3) | 9.1 (2.5 to 21.7) | 9.1 (0.2 to 41.3) |
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.
| Months | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Time to Response (TTR) | 5.75 (2.1 to 13.9) | 2.86 (2.1 to 5.5) | 6.83 (2.6 to 11.1) |
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.
| Score on a scale | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Cycle 5, Day 1 | 4.42 ± 10.273 | 1.11 ± 13.884 | 0.25 ± 22.276 |
| Cycle 9, Day 1 | 1.17 ± 4.916 | 5.56 ± 21.279 | -0.83 ± 17.713 |
| Cycle 13, Day 1 | -3.29 ± 16.650 | 15.00 ± 19.685 | 1.33 ± 21.398 |
| Cycle 17, Day 1 | 0.17 ± 9.326 | 10.00 ± 17.889 | 3.67 ± 23.551 |
| Cycle 21, Day 1 | 4.25 ± 10.905 | 8.33 ± 22.546 | 5.50 ± 18.285 |
| Cycle 25, Day 1 | 4.00 ± 14.422 | -2.50 ± 10.607 | 5.00 ± 7.071 |
| Cycle 29, Day 1 | -2.67 ± 4.619 | -5.00 ± 7.071 | — |
| Cycle 33, Day 1 | -3.00 ± NA | 0.00 ± NA | — |
| Safety Follow-up | -1.50 ± 8.546 | -9.52 ± 21.047 | 12.50 ± 3.536 |
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.
| Score on a scale | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Cycle 5, Day 1 | 7.64 ± 24.220 | 6.67 ± 19.041 | 10.42 ± 24.296 |
| Cycle 9, Day 1 | 8.33 ± 10.541 | 12.04 ± 28.294 | 1.39 ± 21.995 |
| Cycle 13, Day 1 | 4.76 ± 11.644 | -1.67 ± 19.003 | 2.78 ± 15.516 |
| Cycle 17, Day 1 | 2.78 ± 12.546 | 6.94 ± 30.008 | 4.17 ± 21.570 |
| Cycle 21, Day 1 | 12.50 ± 14.434 | 0.00 ± 33.333 | 0.00 ± 20.412 |
| Cycle 25, Day 1 | 14.58 ± 25.797 | -8.33 ± 11.785 | -4.17 ± 5.893 |
| Cycle 29, Day 1 | 16.67 ± 16.667 | -8.33 ± 11.785 | — |
| Cycle 33, Day 1 | 0.00 ± NA | 0.00 ± NA | — |
| Safety Follow-up | 7.74 ± 27.045 | -14.93 ± 26.917 | 20.83 ± 17.678 |
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.
| Score on a scale | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Cycle 5, Day 1 | -2.78 ± 14.312 | 7.02 ± 14.912 | 1.39 ± 41.335 |
| Cycle 9, Day 1 | 0.00 ± 12.172 | -1.39 ± 11.011 | -22.22 ± 41.574 |
| Cycle 13, Day 1 | -1.59 ± 11.878 | -6.67 ± 12.669 | -5.56 ± 18.257 |
| Cycle 17, Day 1 | 9.26 ± 16.355 | 1.85 ± 10.924 | -12.96 ± 16.355 |
| Cycle 21, Day 1 | 0.00 ± 12.830 | 11.11 ± 11.111 | -16.67 ± 14.344 |
| Cycle 25, Day 1 | 0.00 ± 15.713 | 27.78 ± 7.857 | -5.56 ± 7.857 |
| Cycle 29, Day 1 | 3.70 ± 27.962 | 22.22 ± 15.713 | — |
| Cycle 33, Day 1 | 11.11 ± NA | 33.33 ± NA | — |
| Safety Follow-up | -1.59 ± 19.903 | 7.87 ± 30.820 | -44.44 ± 31.427 |
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
| Participants | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| At least one TEAE | 22 | 41 | 10 |
| SAEs | 9 | 21 | 5 |
Collected over Up to approximately 3 years and 1 week. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: ENKTL | 11/22 (50%) | 9/22 (40.9%) | 21/22 (95.5%) |
| Cohort 2: PTCL-NOS, AITL, and ALCL | 26/44 (59.1%) | 21/44 (47.7%) | 39/44 (88.6%) |
| Cohort 3: MF and SS | 3/11 (27.3%) | 5/11 (45.5%) | 10/11 (90.9%) |
| Event | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| Cardiac failureCardiac disorders | 0/22 | 0/44 | 1/11 |
| PyrexiaGeneral disorders | 0/22 | 4/44 | 0/11 |
| Cellulitis staphylococcalInfections and infestations | 0/22 | 0/44 | 1/11 |
| PneumoniaInfections and infestations | 2/22 | 4/44 | 0/11 |
| Pneumonia cryptococcalInfections and infestations | 0/22 | 0/44 | 1/11 |
| Staphylococcal sepsisInfections and infestations | 0/22 | 0/44 | 1/11 |
| Varicella zoster virus infectionInfections and infestations | 0/22 | 0/44 | 1/11 |
| DizzinessNervous system disorders | 0/22 | 0/44 | 1/11 |
| SyncopeNervous system disorders | 0/22 | 1/44 | 1/11 |
| Renal impairmentRenal and urinary disorders | 0/22 | 1/44 | 1/11 |
| Event | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 3/22 | 4/44 | 4/11 |
| Oedema peripheralGeneral disorders | 2/22 | 3/44 | 4/11 |
| PyrexiaGeneral disorders | 6/22 | 13/44 | 4/11 |
| AnaemiaBlood and lymphatic system disorders | 6/22 | 7/44 | 0/11 |
| HypothyroidismEndocrine disorders | 1/22 | 5/44 | 3/11 |
| VomitingGastrointestinal disorders | 2/22 | 0/44 | 3/11 |
| Influenza like illnessGeneral disorders | 0/22 | 1/44 | 3/11 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/22 | 7/44 | 3/11 |
| PruritusSkin and subcutaneous tissue disorders | 2/22 | 6/44 | 3/11 |
| RashSkin and subcutaneous tissue disorders | 1/22 | 2/44 | 3/11 |
| Age, Continuous(Years) | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS | Total |
|---|---|---|---|---|
| Mean | 51.5 ± 16.24 | 55.8 ± 15.03 | 59.4 ± 12.45 | 55.1 ± 15.09 |
| Sex: Female, Male(Participants) | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS | Total |
|---|---|---|---|---|
| Female | 8 | 15 | 3 | 26 |
| Male | 14 | 29 | 8 | 51 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS | Total |
|---|---|---|---|---|
| Asian | 19 | 23 | 2 | 44 |
| White | 2 | 18 | 8 | 28 |
| Not Reported | 1 | 3 | 1 | 5 |
| Region of Enrollment(Participants) | Cohort 1: ENKTL | Cohort 2: PTCL-NOS, AITL, and ALCL | Cohort 3: MF and SS | Total |
|---|---|---|---|---|
| Canada | 0 | 0 | 2 | 2 |
| China | 19 | 22 | 0 | 41 |
| Taiwan | 0 | 1 | 0 | 1 |
| Italy | 2 | 18 | 8 | 28 |
| France | 1 | 3 | 1 | 5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tislelizumab
Lymphoma, T-Cell, Peripheral →