NCT03493451

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Type	Name	Description
DRUG	Tislelizumab	Administered intravenously

Timeline

• Start date: 2018-04-13
• Primary completion: 2021-04-21
• Completion: 2021-04-21
• First posted: 2018-04-10
• Last updated: 2024-10-26
• Results posted: 2022-05-04

Locations

24 sites across 5 countries: Canada, China, France, Italy, Taiwan

Regulatory

• FDA-regulated drug study