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

Anaplastic Large Cell Lymphoma Clinical Trial

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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Adult Nasal Type Extranodal NK/T-cell Lymphoma
  • ALK-negative Anaplastic Large Cell Lymphoma
  • ALK-Positive Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Anaplastic Large Cell Lymphoma, ALK-negative
  • Anaplastic Large Cell Lymphoma, ALK-Positive
  • Angioimmunoblastic T-cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma Recurrent
  • Angioimmunoblastic T-Cell Lymphoma Refractory
  • Cutaneous T-cell Lymphoma
  • Extranodal NK T Cell Lymphoma
  • Extranodal NK T Cell Lymphoma, Nasal
  • Extranodal NK/T-cell Lymphoma
  • Extranodal NK/T-cell Lymphoma, Nasal Type
  • Lymphoma
  • Lymphoma, Extranodal NK-T-Cell
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Neoplasms
  • Peripheral T Cell Lymphoma
  • Peripheral T-cell Lymphoma NOS
  • Peripheral T-Cell Lymphoma Refractory
  • Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • PTCL
Clinical Trial Details
NCT number NCT03493451
Study type Interventional
Source BeiGene
Contact
Status Completed
Phase Phase 2
Start date April 13, 2018
Completion date April 21, 2021
View Details
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