Anaplastic Large Cell Lymphoma Treatment with Brentuximab Vedotin or Crizotinib – Phase II

Brentuximab Vedotin or Crizotinib in Combination with Chemotherapy for Newly Diagnosed Patients with Anaplastic Large Cell Lymphoma

Protocol Description

This multicenter trial by the Children’s Oncology Group studies how well combination chemotherapy with the addition of either brentuximab vedotin or crizotinib works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma (ALCL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Researchers believe that crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders, up to 21 years of age with newly diagnosed stage II-IV ALCL.
Males and Females: Up to 21 years of age

Requirements

Patients enrolled in the study will be randomly placed in one of two treatment plans. One will receive standard chemotherapy with brentuximab vedotin and the other will receive standard chemotherapy with crizotinib during 21-day treatment cycles, of which there are 6. Evaluations are done at intervals to determine whether the disease is better, worse or the same, and whether treatment should continue or end.
Visits: Same number as required for standard chemotherapy
Duration: About 19 weeks

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ANHL12P1)
National Cancer Institute

Primary Investigator

Jean Tersak, MD

Contact Information

For more information about the study or enrollment, please contact:
Jean Tersak, MD
412-692-5055