BNHL-2015 for Children or Adolescents in China (BNHL-2015)

February 9, 2024 updated by: Yi-Jin Gao, Children's Cancer Group, China

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Second University Hospital of Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Risk group 1
Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
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;
Other Names:
  • Protocol A
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;
Other Names:
  • Protocol B
Other: Risk group2
Not or incompletely resected stage I/II disease and LDH <2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
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;
Other Names:
  • Protocol A
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;
Other Names:
  • Protocol B
Other: Risk group3
Stage III with high LDH < 4 times NL, or Stage I,II with LDH >=2 times NL: Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-A-BB-AA-BB-AA-BB) and 13 intrathecal injections; Dosage of Cytarabine, Methotrexate and Etoposide was increased in AA or BB compared with A or B. Vindelsine was used in AA/BB instead of Vincristine in A/B.
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;
Other Names:
  • Protocol A
Drug: Prednisone,Vincristine, Cyclophosphamide
Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
Other Names:
  • Preface
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;
Other Names:
  • Protocol AA
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;
Other Names:
  • Protocol BB
Other: Risk group4
Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.
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;
Other Names:
  • Protocol A
Drug: Prednisone,Vincristine, Cyclophosphamide
Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
Other Names:
  • Preface
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;
Other Names:
  • Protocol AA
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;
Other Names:
  • Protocol BB
Drug: Rituximab
375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Cancer Group, China

Collaborators

Xiangya Hospital of Central South University
Qilu Hospital of Shandong University
Tianjin Medical University Cancer Institute and Hospital
Children's Hospital of Soochow University
West China Second University Hospital
Nanjing Children's Hospital
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China

Investigators

  • Principal Investigator: Yi-Jin Gao, MD, Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 26, 2015

First Submitted That Met QC Criteria

March 28, 2015

First Posted (Estimated)

April 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCG-BNHL-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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