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NCT03493451 · REGISTRY CONDITION SEARCH

Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2024-10-26

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: * Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) * Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) * Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) 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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Duration of Response (DOR)

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outcome · POSTED

Progression-free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Complete Response Rate (CRR)

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outcome · POSTED

Time to Response (TTR)

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outcome · POSTED

Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score

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outcome · POSTED

Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score

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outcome · POSTED

Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score

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outcome · POSTED

Number of Participants With Adverse Events

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Key Inclusion Criteria * Confirmed diagnosis of relapsed or refractory extranodal NK/T-cell lymphoma (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome) * Age 18 years or older * Relapsed or refractory to at least 1 prior systemic therapy * Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) for participants in Cohort 1 and 2 * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 * Life expectancy ≥ 6 months * Adequate respiratory function * Adequate bone marrow function * Adequate renal and hepatic function Key Exclusion Criteria * Known central nervous system (CNS) involvement by lymphoma * Previously received immune checkpoint therapy * Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 or lower prostate cancer * Active autoimmune disease or history of autoimmune diseases that may relapse with some exceptions * Severe or debilitating pulmonary disease * Clinically significant cardiovascular disease * Active fungal, bacterial, and/or viral infection requiring systemic therapy * Known infection with HIV or active viral hepatitis B or C infection * Major surgery within 4 weeks of the first dose of study drug * Pregnant or lactating women * Vaccination with a live vaccine within 35 days prior to the first dose of study drug * Hypersensitivity to tislelizumab * Concurrent participation in another therapeutic clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. 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)
    intervention Names
    1. Drug: Tislelizumab
    label
    Cohort 1: ENKTL
    type
    EXPERIMENTAL
  2. 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)
    intervention Names
    1. Drug: Tislelizumab
    label
    Cohort 2: PTCL-NOS, AITL, and ALCL
    type
    EXPERIMENTAL
  3. 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)
    intervention Names
    1. Drug: Tislelizumab
    label
    Cohort 3: MF and SS
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Cohort 1: ENKTL
    2. Cohort 2: PTCL-NOS, AITL, and ALCL
    3. Cohort 3: MF and SS
    description
    Administered intravenously
    name
    Tislelizumab
    other Names
    1. BGB-A317
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
77
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Overall Response Rate (ORR)
    time Frame
    Up to approximately 3 years and 1 week
secondary Outcomes
  1. description
    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.
    measure
    Duration of Response (DOR)
    time Frame
    Up to approximately 3 years and 1 week
  2. description
    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.
    measure
    Progression-free Survival (PFS)
    time Frame
    Up to approximately 3 years and 1 week
  3. description
    OS defined as the time from first study drug administration to the date of death due to any reason for cohorts 1 and 2.
    measure
    Overall Survival (OS)
    time Frame
    Up to approximately 3 years and 1 week
  4. 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.
    measure
    Complete Response Rate (CRR)
    time Frame
    Up to approximately 3 years and 1 week
  5. description
    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.
    measure
    Time to Response (TTR)
    time Frame
    Up to approximately 3 years and 1 week
  6. description
    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.
    measure
    Quality of Life Assessment: EQ-5D-5L Change From Baseline in Visual Analogue Score
    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)
  7. description
    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.
    measure
    Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Global Health Status Score
    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)
  8. description
    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.
    measure
    Quality of Life Assessment: EORTC QLQ-C30 Change From Baseline in Fatigue Score
    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)
  9. description
    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
    measure
    Number of Participants With Adverse Events
    time Frame
    Up to approximately 3 years and 1 week
Full study description
brief Summary
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: * Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type) * Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL) * Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS) 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).
Source references
references
  1. citation
    Huiqiang Huang, et al. Tislelizumab (BGB-A317) for relapsed/refractory extranodal NK/T-cell lymphoma: preliminary efficacy and safety results from a phase 2 study. Poster Abstract EP1268, European Hematology Association 2020.
    type
    BACKGROUND
  2. citation
    Pier Luigi Zinzani, et al. Tislelizumab (BGB-A317) for relapsed/refractory peripheral T-cell lymphomas: Safety and efficacy results from a phase 2 study. Poster Abstract EP1235, European Hematology Association 2020.
    type
    BACKGROUND
  3. citation
    Bachy E, Savage KJ, Huang H, Kwong YL, Gritti G, Zhang Q, Liberati AM, Cao J, Yang H, Hao S, Hu J, Zhou K, Petrini M, Russo F, Zhang H, Sang W, Ji J, Ferreri AJM, Damaj GL, Liu H, Zhang W, Ke X, Ghiggi C, Huang S, Li X, Yao H, Paik J, Novotny W, Zhou W, Zhu H, Zinzani PL. Treating relapsed/refractory mature T- and NK-cell neoplasms with tislelizumab: a multicenter open-label phase 2 study. Blood Adv. 2023 Aug 22;7(16):4435-4447. doi: 10.1182/bloodadvances.2022009575.
    pmid
    37276067
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice