drugset / Trial / NCT07168980
Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents
Phase 2/3
Recruiting
87 enrolled
Children's Cancer Group, China
Children's Hospital of Soochow University · collabNanjing Children's Hospital · collabQilu Hospital of Shandong University · collabShanghai Children's Medical Center · collabTianjin Medical University Cancer Institute and Hospital · collabWest China Second University Hospital · collabWuhan TongJi Hospital · collabXiangya Hospital of Central South University · collab
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2025-07-01
- Primary completion
- 2030-06-30
- Completion
- 2030-06-30
Publications
- Background Dong 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.
- Background Zhao 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.
- Background Wang 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.
- Background Minard-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.
- Background Gao 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | — |
| Subject | Cytarabine | Small molecule | 2000 mg/m2 | — |
| Subject | Doxorubincin | Unknown | 20 mg/m2 | — |
| Subject | Etoposide | Small molecule | 60 mg/m2 | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 1200 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 500 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 5000 mg/m2 | — |
| Subject | Prednisone | Other / unclassified | 45 mg/m2 | — |
| Subject | Prednisone | Other / unclassified | 60 mg/m2 | — |
| Subject | Vincristine | Small molecule | 1.5 mg/m2 | — |
| Subject | Vindelsine | Unknown | 3 mg/m2 | — |