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Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents
The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.
In our previous study (CCCG-BNHL-2015), four-year EFS was 88.3%, mostly owing to the use of Rituximab. However, four-year EFS was only 73% for group R4. And three-year EFS was even lower, 61% for stage IV and B-AL with LDH≥4ULN. To improve survival for pediatric patients with high risk B-NHL, the investigators launched a new study in China. In this study (CCCG-BNHL-2025), patients with stage III and LDH≥2ULN, any stage IV, and B-AL will be stratified into group R4. Six injections of Rituximab will be used for patients in R4, compared with four injections in CCCG-BNHL-2015. And two injections of Rituximab will be used in the first and second cycles of chemotherapies. The first cycle of chemotherapy will be changed into AA, instead of A. For patients with stage IV (including B-AL) with LDH≥ 4ULN, two cycles of chemotherapies(AA and BB) will be added. Our aim is to test whether intensive chemotherapies with early, adequate, and intensive use of Rituximab will improve the EFS and OS of children and adolescents with highly aggressive B-NHL.
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
Start Date
July 1, 2025
Primary Completion Date
June 30, 2030
Completion Date
June 30, 2030
Last Updated
September 11, 2025
87
ESTIMATED participants
Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
DRUG
Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
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
Prednisone,Vincristine, Cyclophosphamide
DRUG
Lead Sponsor
Children's Cancer Group, China
Collaborators
NCT02405676
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.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02483000