NCT07168980

Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents

Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: Children's Cancer Group, China · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Mature B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone	Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2\~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1;
DRUG	Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone	Ifosphamide 1.2g/m2, D1\~5; Etoposide, 60mg/m2, D3\~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1;
DRUG	Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone	Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2\~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1,8;
DRUG	Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone	Ifosphamide 1.2g/m2, D1\~5; Etoposide, 60mg/m2, D3\~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1
DRUG	Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone	Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2\~4; Vindelsine 3mg/m2 (MAX 5mg), D1; Cytarabine 2g/m2/dose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1,4(CNS2-3),8
DRUG	Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone	Ifosphamide 1.2g/m2, D1\~5; Etoposide, 100mg/m2, D3\~5; Methotrexate, 5g/m2, D1;Vindelsine 3mg/m2 (MAX 5mg), D1; Prednisone 60mg/m2, D1\~7;Intrathecal injection, D1,8
DRUG	Prednisone,Vincristine, Cyclophosphamide	Prednisone 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1

Timeline

• Start date: 2025-07-01
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China