Spots Global Cancer Trial Database for BNHL-2015 for Children or Adolescents in China
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Trial Identification
Brief Title: 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 ID: NCT02405676
Conditions
Interventions
Study Description
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
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
West China Second University Hospital of Sichuan University, Chengdu, Sichuan, China
Contact Details
Name: Yi-Jin Gao, MD
Affiliation: Shanghai Children's Medical Center
Role: PRINCIPAL_INVESTIGATOR
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