Intensive chemotherapy with earlier and increased rituximab for aggressive mature B‑cell non‑Hodgkin lymphoma in children and adolescents

Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents

This protocol will try giving rituximab earlier and more intensively alongside intensified chemotherapy for children and teens with aggressive mature B‑cell non‑Hodgkin lymphoma to improve event‑free and overall survival.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: N/A to 18 Years
• Sex: All
• Sponsor: Children's Cancer Group, China (Research network)
• Drugs / interventions: rituximab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07168980 on ClinicalTrials.gov

What this trial studies

Building on prior CCCG-BNHL-2015 results that showed benefit from rituximab but persistent poor outcomes in the highest‑risk groups, this multi‑center interventional protocol intensifies both chemotherapy and rituximab exposure for pediatric patients with high‑risk disease. Patients meeting high‑risk criteria (stage III with LDH≥2×ULN, any stage IV, or Burkitt leukemia) are stratified to receive six rituximab infusions instead of four, with two rituximab doses given during the first and second chemotherapy cycles. The initial chemotherapy cycle is changed from regimen A to AA, and select very high‑risk patients (stage IV with LDH≥4×ULN) receive two additional chemotherapy cycles (AA and BB). The primary goal is to improve event‑free survival and overall survival compared with historical outcomes from CCCG‑BNHL‑2015.

Who should consider this trial

Good fit: Children and adolescents with histologically or cytologically confirmed mature B‑cell NHL (including Burkitt, DLBCL, PMLBL, or other aggressive mature B‑cell types), who are CD20‑positive, treatment‑naive for rituximab, able to comply with follow‑up, and meet the trial's high‑risk stratification criteria are optimal candidates.

Not a fit: Patients whose tumors are CD20‑negative, those with low‑risk disease not meeting the high‑risk strata, or those excluded for prior rituximab exposure, active hepatitis B carrier status, congenital immunodeficiency, prior malignancy, or pregnancy are unlikely to benefit from this regimen.

Why it matters

Potential benefit: If successful, the intensified rituximab schedule combined with more aggressive chemotherapy could raise event‑free and overall survival for children and adolescents with high‑risk aggressive B‑cell NHL.

How similar studies have performed: Previous work including CCCG‑BNHL‑2015 and other pediatric series showed that adding rituximab improved outcomes overall, but the specific intensified schedule and extra chemotherapy cycles for the highest‑risk children remain novel and are being newly tested.

Eligibility criteria

Inclusion Criteria:

Histology or cytologically confirmed matureB-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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Children's Medical Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Yi-jin Gao — Shanghai Children's Medical Center
• Study coordinator: Yi-jin Gao

Conditions Mature B-cell Non-Hodgkin Lymphoma; mature B-cell non-Hodgkin lymphoma; children; adolescent; rituximab