Clinical Trial: Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma

Brief Summary: This is a single-arm, open-label, multicenter, phase 4 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with relapsed or refractory Systemic Anaplastic Large Cell Lymphoma (SALCL).

Detailed Summary:
Sponsor: Millennium Pharmaceuticals, Inc.

Current Primary Outcome: Objective Response Rate (ORR) as assessed by an independent review facility (IRF) according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]

To determine the antitumor efficacy of single-agent brentuximab vedotin as measured by ORR in patients with relapsed or refractory sALCL following at least 1 multiagent chemotherapy regimen


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of response [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
    To determine the duration of response with brentuximab vedotin.
  • Progression-free survival (PFS) [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
    To determine progression-free survival with brentuximab vedotin.
  • Complete remission rate (CR) [ Time Frame: Until disease progression, death or study closure (up to 5 years after the enrollment of the last patient) ]
    To determine the complete remission rate with brentuximab vedotin.
  • Overall Survival [ Time Frame: Until death or study closure (up to 5 years after the enrollment of the last patient) ]
    To determine overall survival with brentuximab vedotin.


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: July 1, 2013
Date Started: October 2013
Date Completion: April 2020
Last Updated: February 8, 2017
Last Verified: February 2017