A Study of BGB-A317 in Patients With Relapsed or Refractory Mature T- and NK- Neoplasms

Official Title

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

Summary:

This is a multi-centre, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in patients with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There will be two cohorts of patients: - Cohort 1: Patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or non-nasal type) - Cohort 2: Patients with other mature T-cell neoplasms, limited to the following histologies; peripheral T-cell lymphoma- not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma, and anaplastic large cell lymphoma. Approximately 50 patients will be enrolled into Cohort 1 and 40 patients into Cohort 2 for a total sample size of 90 patients. Cohort 2 will include 20 patients with EBV-positive disease and 20 patients with EBV-negative disease. The primary efficacy endpoint is ORR determined by independent central review. Disease response for the primary endpoint will be assessed per the Lugano criteria with the LYRIC modification for immunomodulatory therapy BGB-A317 will be administered intravenously as a 200 mg infusion every 3 weeks (Each cycle consists of 21 days). Study procedures will occur over 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 AEs and SAEs); Survival follow-up phase (duration varying by patient).

Trial Description

Primary Outcome:

  • Objective response rate (ORR)
Secondary Outcome:
  • Duration of response (DOR)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Rate of complete response
  • Time to Response (TTR)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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