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Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China
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.
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.
Age
0 - 16 years
Sex
ALL
Healthy Volunteers
No
West China Second University Hospital of Sichuan University
Chengdu, Sichuan, China
Start Date
January 1, 2015
Primary Completion Date
December 31, 2023
Completion Date
December 1, 2029
Last Updated
March 19, 2026
200
ESTIMATED participants
Prednisone,Vincristine, Cyclophosphamide
DRUG
Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
DRUG
Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
DRUG
Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
DRUG
Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
DRUG
Rituximab
DRUG
Lead Sponsor
Children's Cancer Group, China
Collaborators
NCT07168980
NCT04986865
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT02483000