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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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
• Email: gaoyijin@scmc.com.cn
• Phone: +82064 86-21-38626161

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.