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Recruiting Phase 2/3

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

NCT07168980 · tracked via the Priya Life Science China tracker
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, Prednisone →Prednisone,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
No
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)

FacilityCityRegionStatus
Shanghai Children's Medical Center Shanghai Shanghai Municipality 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