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ACTIVE NOT RECRUITING
NCT02405676
PHASE2/PHASE3

BNHL-2015 for Children or Adolescents in China

Sponsor: Children's Cancer Group, China

View on ClinicalTrials.gov

Summary

The purpose of this study is to test whether adding 4 injections of rituximab and increasing the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with the historical study CCCG-NHL-2010.

Official title: Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China

Key Details

Gender

All

Age Range

Any - 16 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2015-01-01

Completion Date

2029-12

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Prednisone,Vincristine, Cyclophosphamide

Prednisone 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; 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, D1,8;

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

Rituximab

375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;

Locations (1)

West China Second University Hospital of Sichuan University

Chengdu, Sichuan, China