Clinical trial NCT02405676: BNHL-2015 for Children or Adolescents in China
Official title: Treatment Regimen or Children or Adolescent with Mature B-cell NHL or B-AL in China
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Mature B-cell Non-Hodgkin Lymphoma
Keywords: Lymphoma
non-Hodgkin
B-lymphocytes
Child
Multicenter study
Lead sponsor: Children's Cancer Group, China
Sponsor class: NETWORK
Collaborators: name: Tongji Hospital
name: Nanjing Children's Hospital
name: West China Second University Hospital
name: Xiangya Hospital of Central South University
name: Qilu Hospital of Shandong University
name: Children's Hospital of Soochow University
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2015-04-01
Enrollment: 200
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Event free survival
timeFrame: 2 year
Secondary outcomes:
measure: Overall survival
timeFrame: 5 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yi-Jin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.