A Phase I/II Study of Brentuximab (SGN-35) in Pediatric Patients with Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma or Hodgkin Lymphoma

Protocol
11-210
Full Title
A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients with a Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
Phase
I/II
Disease Status
Relapsed/Refractory
Purpose

The purpose of this study is to evaluate the safety and effectiveness of a drug called brentuximab vedotin (SGN-35) in pediatric patients with systemic anaplastic large cell lymphoma (ALCL) or Hodgkin lymphoma that has either returned or persists despite prior therapy.

Brentuximab has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer. It is already approved in the United States for the treatment of ALCL and Hodgkin lymphoma. However, its safety and effectiveness in children and adolescents has not been established.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have systemic ALCL or Hodgkin lymphoma that has returned or persists despite prior therapy.
  • Patient’s lymphoma must express the CD30 protein.
  • Patients must be at least 2 years old and under age 18. Patients with Hodgkin lymphoma must be at least 5 years old and under age 18.

For more information about this study and to inquire about eligibility, please contact Dr. Tanya Trippett at 212-639-8267.

Disease(s)
Lymphoma
Lymphoma: Hodgkin's Disease
Lymphoma: Non-Hodgkin's Lymphoma
Locations
Related Diseases