NCT01716806

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

Detailed description

This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. 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).

Conditions

• Hodgkin Disease
• Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	1.8 mg/kg every 3 weeks by IV infusion
DRUG	bendamustine	70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle
DRUG	dacarbazine	375 mg/m\^2 every 3 weeks by IV infusion
DRUG	nivolumab	3 mg/kg every 3 weeks by IV infusion

Timeline

• Start date: 2012-10-31
• Primary completion: 2023-04-07
• Completion: 2023-09-12
• First posted: 2012-10-30
• Last updated: 2024-06-11
• Results posted: 2024-06-11

Locations

54 sites across 2 countries: United States, Canada