NCT07168980 Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents
| NCT ID | NCT07168980 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Children's Cancer Group, China |
| Condition | Mature B-cell Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 87 participants in total. It began in 2025-07-01 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.
Eligibility Criteria
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.
Contact & Investigator
Yi-jin Gao
PRINCIPAL INVESTIGATOR
Shanghai Children's Medical Center
Frequently Asked Questions
Who can join the NCT07168980 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Mature B-cell Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07168980 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07168980 currently recruiting?
Yes, NCT07168980 is actively recruiting participants. Contact the research team at gaoyijin@scmc.com.cn for enrollment information.
Where is the NCT07168980 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07168980 clinical trial?
NCT07168980 is sponsored by Children's Cancer Group, China. The principal investigator is Yi-jin Gao at Shanghai Children's Medical Center. The trial plans to enroll 87 participants.