Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents

In our previous study (CCCG-BNHL-2015), four-year EFS was 88.3%, mostly owing to the use of Rituximab. However, four-year EFS was only 73% for group R4. And three-year EFS was even lower, 61% for stage IV and B-AL with LDH≥4ULN. To improve survival for pediatric patients with high risk B-NHL, the investigators launched a new study in China. In this study (CCCG-BNHL-2025), patients with stage III and LDH≥2ULN, any stage IV, and B-AL will be stratified into group R4. Six injections of Rituximab will be used for patients in R4, compared with four injections in CCCG-BNHL-2015. And two injections of Rituximab will be used in the first and second cycles of chemotherapies. The first cycle of chemotherapy will be changed into AA, instead of A. For patients with stage IV (including B-AL) with LDH≥ 4ULN, two cycles of chemotherapies(AA and BB) will be added. Our aim is to test whether intensive chemotherapies with early, adequate, and intensive use of Rituximab will improve the EFS and OS of children and adolescents with highly aggressive B-NHL.

Inclusion criteria

• Histology or cytologically confirmed mature B-cell NHL/AL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)
• Able to comply with scheduled follow-up and with management of toxicity
• Signed informed consent

Exclusion criteria

• Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
• Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
• Evidence of pregnancy or lactation period. Past or current anti-cancer treatment except corticosteroids during less than one week.

Exclusion criteria

related to Rituximab :

• Tumor cell negative for CD20
• Prior exposure to rituximab
• Hepatitis B carrier status history of HBV or positive serology.