ANHL1131: Intergroup Trial for Children or Adolescents with B-cell Non-Hodgkin Lymphoma NHL or Mature B-cell Leukemia B- AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients
ID Number 80-0066-11310Principal Investigator(s)
Department(s) or Division(s)
Current/standard treatments for B-NHL or B-AL result in very good outcomes, but do not always stop the cancer from coming back for some patients. Researchers want to find out what effects (good and/or bad) using a drug called rituximab in combination with standard chemotherapy will have on subjects with B-NHL or B-AL. We want to find out if this new approach can improve the treatment success of subjects with B-NHL or B-AL. The use of rituximab for children with B-NHL or B-AL is experimental, and we do not know these things, and that is why we are doing this study.
The drug rituximab is being studied because it has been shown to be of benefit when used with chemotherapy in adult patients with B cell lymphoma. There is some experience with using rituximab in combination with standard chemotherapy to treat children and adolescents, but not enough to know yet whether it is helpful. It is possible that the effectiveness of rituximab will be different than it is in adults. There are differences in the types of B-NHL and B-AL between children and adults. In addition adults are treated with different standard chemotherapy from children
Rituximab is manufactured antibody that attaches to certain proteins that are present on lymphoma cells and causes these cancer cells to die, perhaps by stimulating the body’s own immune system (the system that recognizes and attacks cells that are not normal body cells). An antibody is a natural protein product used by the body’s immune system to fight foreign or diseased cells.
It is not known if adding rituximab will be helpful for the treatment of children and adolescents with B-NHL or B-AL, and it may increase the side effects of treatment.
The chemotherapy used in this study is considered standard therapy, except for a few modifications. These modifications are designed to increase the effectiveness of the therapy for children and adolescents with disease in their spinal fluid (fluid around the brain and spinal cord). In addition we have also made other changes aimed at reducing the side effects of treatment while maintaining good treatment outcomes, based on results from previous studies.
Venesha White (212) 241-3744
Recruiting Patients: Yes