A Phase II Study of Brentuximab Vedotin or Crizotinib in Combination with Chemotherapy for Children and Adolescents Newly Diagnosed Anaplastic Large Cell Lymphoma

Full Title

A Randomized Phase II study of Brentuximab Vedotin (NSC# 749710) and Crizotinib (NSC# 749005) in Patients with Newly Diagnosed Anaplastic Large Cell Lymphoma (ALCL) IND #117117 (ANHL12P1)(CIRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of combining conventional chemotherapy with either brentuximab vedotin or crizotinib in children and adolescents newly diagnosed with anaplastic large cell lymphoma (ALCL).

Brentuximab vedotin is used to treat systemic ALCL and Hodgkin lymphoma in adults. 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) that kills the cancer. Crizotinib is used to treat lung cancers that contain a protein called ALK, which is also made by some lymphoma cells.

Patients will be randomly assigned to receive either brentuximab vedotin or crizotinib in addition to chemotherapy. Crizotinib is taken orally (by mouth), while the other medications are given intravenously (by vein) or intrathecally (into the spinal fluid).

Eligibility

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

  • Patients must have newly diagnosed stage II-IV ALCL that contains the ALK and CD30 proteins.
  • This study is for patients under age 22.

For more information about this study and to inquire about eligibility, please contact Dr. Neerav Shukla at 212-639-5158.

Protocol

16-218

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

Locations