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

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ClinicalTrials.gov Identifier: NCT02405676
Recruitment Status : Recruiting
First Posted : April 1, 2015
Last Update Posted : February 7, 2019
Sponsor:
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
Information provided by (Responsible Party):
Yi-Jin Gao, Children's Cancer Group, China

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.

Condition or disease Intervention/treatment Phase
Mature B-cell Non-Hodgkin Lymphoma Drug: Prednisone,Vincristine, Cyclophosphamide Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone Drug: Rituximab Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China
Study Start Date : January 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: Protocol B

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 Name: 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 Name: Protocol B

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

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 Name: Protocol A

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 Name: 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 Name: Protocol BB

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

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 Name: Protocol A

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 Name: 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 Name: Protocol BB

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




Primary Outcome Measures :
  1. Event free survival [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 year ]


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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405676


Contacts
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Contact: Yi-Jin Gao, MD 86-21-38626161 ext 82064 gaoyijin@scmc.com.cn
Contact: Jing-Yan Tang, MD tangjingyan@scmc.com.cn

Locations
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China, Sichuan
West China Second University Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China
Contact: Yi-Ping Zhu, MD       zhuyiping@918.com   
Contact: Xia Guo, MD       guoxkl@163.com   
Sponsors and Collaborators
Children's Cancer Group, China
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
Investigators
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Principal Investigator: Yi-Jin Gao, MD Shanghai Children's Medical Center

Publications of Results:

Other Publications:
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Responsible Party: Yi-Jin Gao, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiaotong University, Shanghai, China, Children's Cancer Group, China
ClinicalTrials.gov Identifier: NCT02405676     History of Changes
Other Study ID Numbers: CCCG-BNHL-2015
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Keywords provided by Yi-Jin Gao, Children's Cancer Group, China:
Lymphoma
non-Hodgkin
B-lymphocytes
Child
Multicenter study
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Prednisone
Cyclophosphamide
Ifosfamide
Isophosphamide mustard
Rituximab
Methotrexate
Etoposide
Etoposide phosphate
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Abortifacient Agents, Nonsteroidal