Clinical trial · Interventional
Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents
Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents
NCT07168980CI-TRIAL-00113697B-NHLrecruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mature B-cell Non-Hodgkin Lymphoma | Mature B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone | Drug | — | UNRESOLVED |
| Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone | Drug | — | UNRESOLVED |
| Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone | Drug | — | UNRESOLVED |
| Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone | Drug | — | UNRESOLVED |
| Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone | Drug | — | UNRESOLVED |
| Prednisone,Vincristine, Cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Risk group 1
- description
- Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
- interventionNames
- Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
- Drug: Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
- type
- OTHER
- label
- Risk group 2
- description
- Not or incompletely resected stage I/II disease and LDH \<2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
- interventionNames
- Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
- Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
- type
- OTHER
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDDong J, Xu Z, Guo X, Ye F, Fan C, Gao J, Gao Y, Yang L. Effect of rituximab on immune status in children with aggressive mature B-cell lymphoma/leukemia-a prospective study from CCCG-BNHL-2015. Heliyon. 2024 Mar 5;10(5):e27305. doi: 10.1016/j.heliyon.2024.e27305. eCollection 2024 Mar 15. PMID 38495131
- BACKGROUNDZhao J, Liu TF, Wu KF, Yang LC, Xu XJ, Lu J, Shao JB, Li F, Ma FT, Guo X, Li H, Liu AG, Wang NL, Shen HP, Li Y, Liu SX, Liang CD, Shen SH, Fang YJ, Gao YJ. Clinical and molecular characteristics of paediatric mature B-cell acute lymphocytic leukaemia and non-Hodgkin lymphoma with bone marrow involvement: A joint study between the CCCG leukaemia and lymphoma groups. Br J Haematol. 2025 Apr;206(4):1149-1159. doi: 10.1111/bjh.20011. Epub 2025 Feb 17. PMID 39962993
- BACKGROUNDWang X, Ding L, Fang Y, Yan J, Gao J, Yang L, Liu A, Lu J, Wang J, Zhang A, Gao Y, Ju X. The Prognostic and Risk Factors for Children With High-Risk Mature B-Cell Non-Hodgkin's Lymphoma: A Retrospective Multicenter Study. Cancer Med. 2024 Nov;13(21):e70309. doi: 10.1002/cam4.70309. PMID 39513286
- BACKGROUNDMinard-Colin V, Auperin A, Pillon M, Burke GAA, Barkauskas DA, Wheatley K, Delgado RF, Alexander S, Uyttebroeck A, Bollard CM, Zsiros J, Csoka M, Kazanowska B, Chiang AK, Miles RR, Wotherspoon A, Adamson PC, Vassal G, Patte C, Gross TG; European Intergroup for Childhood Non-Hodgkin Lymphoma; Children's Oncology Group. Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children. N Engl J Med. 2020 Jun 4;382(23):2207-2219. doi: 10.1056/NEJMoa1915315. PMID 32492302
- BACKGROUNDGao YJ, Fang YJ, Gao J, Yan J, Yang LC, Liu AG, Ju XL, Lu J, Han YL, Wang J, Xie M, Guo X, Tang JY. A prospective multicenter study investigating rituximab combined with intensive chemotherapy in newly diagnosed pediatric patients with aggressive mature B cell non-Hodgkin lymphoma (CCCG-BNHL-2015): a report from the Chinese Children's Cancer Group. Ann Hematol. 2022 Sep;101(9):2035-2043. doi: 10.1007/s00277-022-04904-w. Epub 2022 Jul 13. PMID 35829780