A Study of Brentuximab Vedotin in Adults Age 60 and Above With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

Status: Active

Description

This trial will study brentuximab vedotin to find out whether it is an effective treatment in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). The study will look at brentuximab vedotin alone and combined with other drugs.

Eligibility Criteria

Inclusion Criteria

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naïve patients with CD30-expressing PTCL (Part F)
  • 75+ years of age or 60+ years and have depressed ejection fraction or moderately severe renal dysfunction (Parts E and F only)
  • Ineligible for initial conventional combination chemotherapy for HL (Parts A, B, C, D, E) or CD30-expressing PTCL (Part F), or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3

Exclusion Criteria

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • Concurrent use of other investigational agents
  • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
  • History of another malignancy within 1 year before first dose of study drug (Parts E and F only)

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: Active
Contact: Kristin L. Lantis
Phone: 804-828-2177
Email: kllantis@vcu.edu

Trial Objectives and Outline

This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy in patients who are age 60 years or more. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Seattle Genetics

Trial IDs

Primary ID SGN35-015
Secondary IDs NCI-2012-02209
Clinicaltrials.gov ID NCT01716806