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

Official Title

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

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.

Trial Description

Primary Outcome:

• Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
• ORR according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
• ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)

Secondary Outcome:

• Incidence of adverse events
• Incidence of laboratory abnormalities
• Complete remission (CR) rate
• Duration of complete response
• Duration of objective response
• Progression-free survival
• Disease control rate
• ORR according to Lugano criteria per BICR (Parts E and F)
• B symptom resolution rate
• Blood concentrations of brentuximab vedotin
• Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
• Blood concentrations of nivolumab (Part D only)
• Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)
• Overall survival (Parts E and F only)

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).

View this trial on ClinicalTrials.gov