Skip to main content
OpenTrials
Completed

NCT Number: NCT03493451

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral T Cell Lymphoma ALK-Positive Anaplastic Large Cell Lymphoma ALK-negative Anaplastic Large Cell Lymphoma Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Anaplastic Large Cell Lymphoma, ALK-Positive Anaplastic Large Cell Lymphoma, ALK-negative Angioimmunoblastic T-Cell Lymphoma Recurrent Angioimmunoblastic T-Cell Lymphoma Refractory Angioimmunoblastic T-cell Lymphoma Cutaneous T-Cell Lymphoma Disease Attributes Extranodal NK T Cell Lymphoma Extranodal NK T Cell Lymphoma, Nasal Extranodal NK/T-cell Lymphoma Extranodal NK/T-cell Lymphoma, Nasal Type Hemic and Lymphatic Diseases Immune System Diseases Immunoblastic Lymphadenopathy Immunoproliferative Disorders Lymphadenopathy Lymphatic Diseases Lymphoma Lymphoma, Extranodal NK-T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type PTCL Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified Peripheral T-cell Lymphoma NOS Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

British Columbia Cancer Agency the Vancouver Centre, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab

Drug

Administered intravenously

Other names: BGB-A317

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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 outcomes

  1. Duration of Response (DOR)

    Time frame: 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.

  2. Progression-free Survival (PFS)

    Time frame: 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.

  3. Overall Survival (OS)

    Time frame: 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.

  4. Complete Response Rate (CRR)

    Time frame: 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.

  5. Time to Response (TTR)

    Time frame: 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.

  6. 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)

    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.

  7. 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)

    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.

  8. 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)

    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.

  9. Number of Participants With Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study title

A Phase 2, Open-Label Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK-cell Neoplasms

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.