Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• Histology or cytologically confirmed mature B-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
Locations
Other Locations
China
Shanghai Children's Medical Center
RECRUITING
Shanghai
Contact Information
Primary
Yi-jin Gao
gaoyijin@scmc.com.cn
+82064 86-21-38626161
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 87
Treatments
Other: Risk group 1
Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
Other: Risk group 2
Not or incompletely resected stage I/II disease and LDH \<2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
Other: Risk group 3
Stage III with LDH \< 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)
Other: Risk group 4
Stage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)
Related Therapeutic Areas
Sponsors
Collaborators: Children's Hospital of Soochow University, Qilu Hospital of Shandong University, Nanjing Children's Hospital, Wuhan TongJi Hospital, Shanghai Children's Medical Center, Tianjin Medical University Cancer Institute and Hospital, West China Second University Hospital, Xiangya Hospital of Central South University
Leads: Children's Cancer Group, China