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

NCT07168980 · tracked via the Priya Life Science China tracker

Sponsor

Children's Cancer Group, China

Phase

Phase 2/3

Started

2025-07-01

Last updated

2026-06-04

Condition(s) studied

Mature B-cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, PrednisoneDrug: Ifosphamide, Etoposide, Methotrexate, Vincristine, PrednisoneCyclophosphamide, Vincristine, Cytarabine, Doxorubincin, PrednisoneIfosphamide, Etoposide, Methotrexate, Vincristine, PrednisoneCyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, PrednisoneIfosphamide, Etoposide, Methotrexate, Vindelsine, PrednisonePrednisone,Vincristine, Cyclophosphamide

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: 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;

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;

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

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

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

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

Study 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

Sex

ALL

Min age

—

Max age

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. Exclusion Criteria related to Rituximab : * Tumor cell negative for CD20 * Prior exposure to rituximab * Hepatitis B carrier status history of HBV or positive serology.

Primary outcome measure(s)

Event free survival — 3 years

Trial sites (1)

Facility	City	Region	Status
Shanghai Children's Medical Center	Shanghai	Shanghai Municipality	Recruiting

More Children's Cancer Group, China trials in China

CCCG-ALCL-2020 for Chinese Children and Adolescents With Newly Diagnosed High-risk ALCL Active, not recruiting

CCCG-HD-2018 for Children and Adolescents With Newly Diagnosed Hodgkin Lymphoma Active, not recruiting

BNHL-2015 for Children or Adolescents in China Active, not recruiting

Shanghai Epidemiology Study for Adolescents and Children with Cancer Recruiting

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment Recruiting

Other trials for the same condition

BNHL-2015 for Children or Adolescents in China Active, not recruiting

A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07168980 on ClinicalTrials.gov ↗ ← All trials in China