BNHL-2015 for Children or Adolescents in China

Mature B-cell Non-Hodgkin Lymphoma Clinical Trial

— BNHL-2015  

Official title:

Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02405676
• Other study ID #: CCCG-BNHL-2015
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2015
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Children's Cancer Group, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In our previous study (CCCG-NHL-2010), two-year EFS was 100% for Stage I, 91.3% ± 6.1% for Stage II, 75.8% ± 4.4% for Stage III, 56.3% ± 13.5% for Stage IV, and 36.4% ± 14.5% for B-AL, respectively. To improve survival for pediatric patients with B-NHL/B-AL, the investigators launched a new study in China. Compared with our previous treatment regimens (CCCG-2010), patients with stage III and LDH>4 times NL, any stage IV or B-AL were stratified into R4. The dose of methotrexate was increased to 5000mg/m2 for patients in R3 or R4 (previously 3000mg/m2). Four injections of rituximab was added to the chemotherapy for patients in R4. Our aim is to test whether adding rituximab or high dose of methotrexate (5000mg/m2) would improving 2-year EFS for patients in advanced groups.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• 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 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.

Related Conditions & MeSH terms

• Lymphoma, B-Cell
• Mature B-cell Non-Hodgkin Lymphoma

Intervention

Drug:
• Prednisone,Vincristine, Cyclophosphamide
Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
• Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;
• Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
Ifosphamide 1.2g/m2, D1~5; Etoposide, 60mg/m2, D3~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1;
• Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4;Vindelsine 3mg/m2 (MAX 5mg), D1; Cytarabine 2g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;
• Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
Ifosphamide 1.2g/m2, D1~5; Etoposide, 100mg/m2, D3~5; Methotrexate, 5g/m2, D1;Vindelsine 3mg/m2 (MAX 5mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;
• Rituximab
375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;

Locations

Country	Name	City	State
China	West China Second University Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (8)

Lead Sponsor	Collaborator
Children's Cancer Group, China	Children's Hospital of Soochow University, Nanjing Children's Hospital, Qilu Hospital of Shandong University, Tianjin Medical University Cancer Institute and Hospital, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China, West China Second University Hospital, Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

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 Childr — View Citation

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 diag — View Citation

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. — View Citation

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 — View Citation

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 schedu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival		2 year
Secondary	Overall survival		5 year