Phase II Clinical Trial for Newly Diagnosed Children and Adolescents with Localized Lymphoblastic Lymphoma (Japanese Leukemia/Lymphoma Study Group Trial LLB-NHL03) : Study Protocol for Nationwide Multicenter Trial

Pediatric patients with lymphoblastic lymphoma are generally treated using the Berlin-Frankfurt-Munster (BFM) 90 protocol, which is the standard treatment strategy for pediatric acute lymphoblastic leukemia, and have a favorable outcome. However, this intense regimen includes high total doses of anthracycline and alkylating agents, and is known to cause late complications. We therefore planned a clinical trial to examine the efficacy and safety of a modified BFM regimen. We expect that this phase II, nationwide multicenter trial will help to establish an effective and safer standard therapy for stage I/II pediatric lymphoblastic lymphoma.