drugset / Trial / NCT02405676
BNHL-2015 for Children or Adolescents in China
Phase 2/3
Active not recruiting
200 enrolled
Children's Cancer Group, China
Children's Hospital of Soochow University · collabNanjing Children's Hospital · collabQilu Hospital of Shandong University · collabTianjin Medical University Cancer Institute and Hospital · collabTongji Hospital · collabWest China Second University Hospital · collabXiangya Hospital of Central South University · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to test whether adding 4 injections of rituximab and increasing the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with the historical study CCCG-NHL-2010.
Timeline
- Start
- 2015-01-01
- Primary completion
- 2023-12-31
- Completion
- 2029-12
Publications
- Background Miles RR, Arnold S, Cairo MS. Risk factors and treatment of childhood and adolescent Burkitt lymphoma/leukaemia. Br J Haematol. 2012 Mar;156(6):730-43. doi: 10.1111/j.1365-2141.2011.09024.x. Epub 2012 Jan 20.
- Results Reiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306.
- Results Woessmann W, Seidemann K, Mann G, Zimmermann M, Burkhardt B, Oschlies I, Ludwig WD, Klingebiel T, Graf N, Gruhn B, Juergens H, Niggli F, Parwaresch R, Gadner H, Riehm H, Schrappe M, Reiter A; BFM Group. The impact of the methotrexate administration schedule and dose in the treatment of children and adolescents with B-cell neoplasms: a report of the BFM Group Study NHL-BFM95. Blood. 2005 Feb 1;105(3):948-58. doi: 10.1182/blood-2004-03-0973. Epub 2004 Oct 14.
- Results Meinhardt A, Burkhardt B, Zimmermann M, Borkhardt A, Kontny U, Klingebiel T, Berthold F, Janka-Schaub G, Klein C, Kabickova E, Klapper W, Attarbaschi A, Schrappe M, Reiter A; Berlin-Frankfurt-Munster group. Phase II window study on rituximab in newly diagnosed pediatric mature B-cell non-Hodgkin's lymphoma and Burkitt leukemia. J Clin Oncol. 2010 Jul 1;28(19):3115-21. doi: 10.1200/JCO.2009.26.6791. Epub 2010 Jun 1.
- Results Goldman S, Smith L, Anderson JR, Perkins S, Harrison L, Geyer MB, Gross TG, Weinstein H, Bergeron S, Shiramizu B, Sanger W, Barth M, Zhi J, Cairo MS. Rituximab and FAB/LMB 96 chemotherapy in children with Stage III/IV B-cell non-Hodgkin lymphoma: a Children's Oncology Group report. Leukemia. 2013 Apr;27(5):1174-7. doi: 10.1038/leu.2012.255. Epub 2012 Sep 3. No abstract available.
- 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 | 1 g | — |
| Subject | Cytarabine | Small molecule | 2 g | — |
| Subject | Etoposide | Small molecule | 60 mg/m2 | — |
| Subject | Etoposide | Small molecule | 100 mg/m2 | — |
| Subject | Methotrexate | Small molecule | 0.5 g | — |
| Subject | Methotrexate | Small molecule | 5 g | — |
| Subject | Prednisone | Other / unclassified | 45 mg/m2 | — |
| Subject | Prednisone | Other / unclassified | 60 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Vindelsine | Unknown | 3 mg/m2 | — |
| Background | Doxorubincin | Unknown | 20 mg/m2 | — |
| Background | Ifosfamide | Small molecule | 1.2 g/kg | — |
| Background | Vincristine | Small molecule | 1.5 mg/m2 | — |