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NCT Number: NCT02405676

BNHL-2015 for Children or Adolescents in China

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mature B-cell Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

West China Second University Hospital of Sichuan University

Chengdu, Sichuan, China

About this study

In our previous study (CCCG-NHL-2010), two-year EFS was 100% for Stage I, 91.3% ± 6.1% for Stage II, 75.8% ± 4.4% for Stage III, 56.3% ± 13.5% for Stage IV, and 36.4% ± 14.5% for B-AL, respectively. To improve survival for pediatric patients with B-NHL/B-AL, the investigators launched a new study in China. Compared with our previous treatment regimens (CCCG-2010), patients with stage III and LDH>4 times NL, any stage IV or B-AL were stratified into R4. The dose of methotrexate was increased to 5000mg/m2 for patients in R3 or R4 (previously 3000mg/m2). Four injections of rituximab was added to the chemotherapy for patients in R4. Our aim is to test whether adding rituximab or high dose of methotrexate (5000mg/m2) would improving 2-year EFS for patients in advanced groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histology or cytologically confirmed matureB-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.

Treatment and study plan

Prednisone,Vincristine, Cyclophosphamide

Drug

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

Other names: Preface

Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone

Drug

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;

Other names: Protocol A

Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone

Drug

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;

Other names: Protocol B

Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone

Drug

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;

Other names: Protocol AA

Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone

Drug

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;

Other names: Protocol BB

Rituximab

Drug

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

Primary outcomes

  1. Event free survival

    Time frame: 2 year

Secondary outcomes

  1. Overall survival

    Time frame: 5 year

Sponsors and collaborators

Lead sponsor

Children's Cancer Group, China

Network

Collaborators

  • Children's Hospital of Soochow University
  • Nanjing Children's Hospital
  • Qilu Hospital of Shandong University
  • Tianjin Medical University Cancer Institute and Hospital
  • Tongji Hospital
  • West China Second University Hospital
  • Xiangya Hospital of Central South University

Registry information

Official study title

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

Acronym: BNHL-2015

Important dates

Study start
2015
Primary completion
2023
Study completion
2029
First posted
Apr 1, 2015
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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