Non-Hodgkin Lymphoma or B-Cell Leukemia Evaluation of Rituximab– Phase II/III

Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma or Mature B-cell Leukemia: Evaluation of Rituximab Efficacy and Safety in High Risk Patients

Protocol Description

This multicenter trial studies how well combination chemotherapy with or without rituximab works in treating younger patients with stage III-IV B-cell non-Hodgkin lymphoma (B-NHL) or B-cell acute leukemia (B-AL). The study is organized by the Children’s Oncology Group in collaboration with the European Intergroup for Childhood Non-Hodgkin Lymphoma. Through it, researchers hope to determine whether rituximab when added to standard chemotherapy, can help prevent recurrence of B-NHL and B-AL.

Study Level: Phase II/III

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients of both genders ages 6 months to 17 years, who have been diagnosed with high risk B-NHL or mature B-AL.
Males and Females: Ages 6 months to 17 years

Requirements

Study participants will be assigned to a study group based on their diagnosis, and then be randomly assigned to receive standard therapy or standard therapy plus rituximab as part of the induction and consolidation stages of treatment. Patients identified with cancer cells in the brain an/or spinal fluid will also receive courses of maintenance therapy after completion of induction and consolidation stages.
Visits: Same as required for standard care for these conditions
Duration: Approximately 3 to 5 months, depending on the study arm in which the patient is enrolled, with long-term follow-up of up to 10 years

Status: Open to Enrollment

Source(s) of Support

Children’s Oncology Group (ANHL1131)
National Cancer Institute

Primary Investigator

Jean M. Tersak, MD

Contact Information

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