Status:
RECRUITING
Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents
Lead Sponsor:
Children's Cancer Group, China
Collaborating Sponsors:
Shanghai Children's Medical Center
Nanjing Children's Hospital
Conditions:
Mature B-cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
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 a...
Detailed Description
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 stag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT07168980
Start Date
July 1 2025
End Date
June 30 2030
Last Update
September 11 2025
Active Locations (1)
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1
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China, 201315