BNHL-2015 for Children or Adolescents in China

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.

Conditions

• Mature B-cell Non-Hodgkin Lymphoma

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;

Sponsors & Collaborators

• Tongji Hospital

  collaborator OTHER

• Nanjing Children's Hospital

  collaborator OTHER

• West China Second University Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Children's Hospital of Soochow University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Children's Cancer Group, China

  lead NETWORK

Principal Investigators

• Yi-Jin Gao, MD · Shanghai Children's Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-01

Primary Completion

2023-12-31

Completion

2029-12-31

Countries

• China

Study Locations