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

Primary Purpose

Mature B-cell Non-Hodgkin Lymphoma

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone,Vincristine, Cyclophosphamide
Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
Rituximab
Sponsored by
Children's Cancer Group, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mature B-cell Non-Hodgkin Lymphoma focused on measuring Lymphoma, non-Hodgkin, B-lymphocytes, Child, Multicenter study

Eligibility Criteria

undefined - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Second University Hospital of Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Risk group 1

Risk group2

Risk group3

Risk group4

Arm Description

Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);

Not or incompletely resected stage I/II disease and LDH <2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;

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.

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.

Outcomes

Primary Outcome Measures

Event free survival

Secondary Outcome Measures

Overall survival

Full Information

First Posted
February 26, 2015
Last Updated
February 7, 2023
Sponsor
Children's Cancer Group, China
Collaborators
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China, Nanjing Children's Hospital, West China Second University Hospital, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Children's Hospital of Soochow University, Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02405676
Brief Title
BNHL-2015 for Children or Adolescents in China
Acronym
BNHL-2015
Official Title
Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Cancer Group, China
Collaborators
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China, Nanjing Children's Hospital, West China Second University Hospital, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University, Children's Hospital of Soochow University, Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mature B-cell Non-Hodgkin Lymphoma
Keywords
Lymphoma, non-Hodgkin, B-lymphocytes, Child, Multicenter study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Risk group 1
Arm Type
Other
Arm Description
Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
Arm Title
Risk group2
Arm Type
Other
Arm Description
Not or incompletely resected stage I/II disease and LDH <2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
Arm Title
Risk group3
Arm Type
Other
Arm Description
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.
Arm Title
Risk group4
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisone,Vincristine, Cyclophosphamide
Other Intervention Name(s)
Preface
Intervention Description
Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
Other Intervention Name(s)
Protocol A
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
Other Intervention Name(s)
Protocol B
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
Other Intervention Name(s)
Protocol AA
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
Other Intervention Name(s)
Protocol BB
Intervention Description
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;
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;
Primary Outcome Measure Information:
Title
Event free survival
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
5 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Jin Gao, MD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Second University Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22260323
Citation
Miles RR, Arnold S, Cairo MS. Risk factors and treatment of childhood and adolescent Burkitt lymphoma/leukaemia. Br J Haematol. 2012 Mar;156(6):730-43. doi: 10.1111/j.1365-2141.2011.09024.x. Epub 2012 Jan 20.
Results Reference
background
PubMed Identifier
10552938
Citation
Reiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306.
Results Reference
result
PubMed Identifier
15486066
Citation
Woessmann W, Seidemann K, Mann G, Zimmermann M, Burkhardt B, Oschlies I, Ludwig WD, Klingebiel T, Graf N, Gruhn B, Juergens H, Niggli F, Parwaresch R, Gadner H, Riehm H, Schrappe M, Reiter A; BFM Group. The impact of the methotrexate administration schedule and dose in the treatment of children and adolescents with B-cell neoplasms: a report of the BFM Group Study NHL-BFM95. Blood. 2005 Feb 1;105(3):948-58. doi: 10.1182/blood-2004-03-0973. Epub 2004 Oct 14.
Results Reference
result
PubMed Identifier
20516455
Citation
Meinhardt A, Burkhardt B, Zimmermann M, Borkhardt A, Kontny U, Klingebiel T, Berthold F, Janka-Schaub G, Klein C, Kabickova E, Klapper W, Attarbaschi A, Schrappe M, Reiter A; Berlin-Frankfurt-Munster group. Phase II window study on rituximab in newly diagnosed pediatric mature B-cell non-Hodgkin's lymphoma and Burkitt leukemia. J Clin Oncol. 2010 Jul 1;28(19):3115-21. doi: 10.1200/JCO.2009.26.6791. Epub 2010 Jun 1.
Results Reference
result
PubMed Identifier
22940833
Citation
Goldman S, Smith L, Anderson JR, Perkins S, Harrison L, Geyer MB, Gross TG, Weinstein H, Bergeron S, Shiramizu B, Sanger W, Barth M, Zhi J, Cairo MS. Rituximab and FAB/LMB 96 chemotherapy in children with Stage III/IV B-cell non-Hodgkin lymphoma: a Children's Oncology Group report. Leukemia. 2013 Apr;27(5):1174-7. doi: 10.1038/leu.2012.255. Epub 2012 Sep 3. No abstract available.
Results Reference
result
PubMed Identifier
35829780
Citation
Gao YJ, Fang YJ, Gao J, Yan J, Yang LC, Liu AG, Ju XL, Lu J, Han YL, Wang J, Xie M, Guo X, Tang JY. A prospective multicenter study investigating rituximab combined with intensive chemotherapy in newly diagnosed pediatric patients with aggressive mature B cell non-Hodgkin lymphoma (CCCG-BNHL-2015): a report from the Chinese Children's Cancer Group. Ann Hematol. 2022 Sep;101(9):2035-2043. doi: 10.1007/s00277-022-04904-w. Epub 2022 Jul 13.
Results Reference
derived

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BNHL-2015 for Children or Adolescents in China

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