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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07168980

Acronym

B-NHL

Enrollment

Registered

2025-09-11

Start date

2025-07-01

Completion date

2030-06-30

Last updated

2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mature B-cell Non-Hodgkin Lymphoma

Keywords

mature B-cell non-Hodgkin lymphoma, children, adolescent, rituximab

Brief 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.

Interventions

DRUGCyclophosphamide, 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;

DRUGDrug: 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;

DRUGIfosphamide, 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

DRUGCyclophosphamide, 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

DRUGIfosphamide, 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

DRUGPrednisone,Vincristine, Cyclophosphamide

Prednisone 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Arms and Interventions

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study * Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology. * Evidence of pregnancy or lactation period. Past or current anti-cancer treatment except corticosteroids during less than one week.

Design outcomes

Primary

Measure	Time frame
Event free survival	3 years

Secondary

Measure	Time frame
Overall survival	3 years

Countries

China

Contacts

CONTACTYi-jin Gao

gaoyijin@scmc.com.cn+82064 86-21-38626161

PRINCIPAL_INVESTIGATORYi-jin Gao

Shanghai Children's Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026