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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2020

Interventions

  • Drug: brentuximab vedotin
    • Brentuximab vedotin will be administered as a single intravenous (IV) infusion over 30 minutes on Day 1 of each 3 week cycle for up to a maximum of 16 cycles and should be administered for a minimum of 8 cycles for patients who achieve stable disease or better.

Arms, Groups and Cohorts

  • Experimental: Brentuximab vedotin
    • 1.8 mg/kg IV infusion

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female patients age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
  • Bidimensional measurable disease
  • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Female patients who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
  • Male patients who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
  • Clinical laboratory values as specified in the study protocol

Exclusion Criteria

  • Previous treatment with brentuximab vedotin.
  • Previously received an allogeneic transplant.
  • Patients with current diagnosis of primary cutaneous ALCL (patients whose ALCL has transformed to sALCL are eligible).
  • Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
  • Female patients who are lactating and breastfeeding or pregnant
  • Known human immunodeficiency virus (HIV) positive
  • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Millennium Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Millennium Pharmaceuticals, Inc.

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