Clinical Trial: Cancer

High Risk B-Cell NHL or Mature B-Cell Leukemia Study

Full Name

High Risk B-Cell NHL or Mature B-Cell Leukemia/ ANHL1131: Intergroup Trial for Children or Adolescents with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients (PRO00001243 – CIRB)

Description

Patients with Primary Mediastinal Large B-Cell Lymphoma (PMBL) will receive 1 dose of rituximab in each treatment course (total of 6 doses – courses are repeated every 21 days for a total of 6 courses) in combination with the DA EPOCH chemotherapy.
Patients with advanced stage B-cell Non-Hodgkin's Lymphoma (B-NHL) or mature B-cell Leukemia (B-AL) will be divided into 1 of 3 groups, depending on the stage of their disease. Patients who have advanced B-NHL but who do not have cancer cells in the brain or in the spinal fluid and, who if disease is present in the bone marrow, have less than 25% cancer cells will be assigned to Group B. Patients who have B-AL (more or exactly 25% cancer cells in the bone marrow) with no cancer cells in the brain, and patients who have cancer cells in or around the brain, but not in the spinal fluid, with or without bone marrow involvement, will be assigned to Group C1. Patients who have cancer cells in the spinal fluid will be assigned to group C3. In each group, patients will be randomly assigned to receive chemotherapy with rituximab, or chemotherapy without rituximab. All patients randomized to receive rituximab will get a total of 6 doses given by infusion into the veins.

Eligibility

Inclusion Criteria
  • Must be 6 months to less than 18 years of age at the time of consent
  • Must have appropriate diagnosis
  • Must not have past or current anti-cancer treatment except corticosteroids during less than one week
  • Must not have prior exposure to rituximab
  • Must not be participating in another investigational drug clinical trial
  • Males and females of reproductive potential must agree to use an effective method of birth control during treatment and for 12 months after treatment for women (takes into account the characteristics of rituximab), and for 5 months after treatment for men (takes into account the characteristics of methotrexate)