Full TitleA 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 Back to top
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.Back to top
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.