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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 26, 2015
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date February 7, 2019
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2015)
Event free survival [ Time Frame: 2 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02405676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2015)
Overall survival [ Time Frame: 5 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BNHL-2015 for Children or Adolescents in China
Official Title  ICMJE Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Mature B-cell Non-Hodgkin Lymphoma
Intervention  ICMJE
  • 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: 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
  • 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;
Study Arms  ICMJE
  • 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);
    Interventions:
    • Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
    • Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
  • 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;
    Interventions:
    • Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
    • Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone
  • 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.
    Interventions:
    • Drug: Prednisone,Vincristine, Cyclophosphamide
    • Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
    • Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
    • Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
  • 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.
    Interventions:
    • Drug: Prednisone,Vincristine, Cyclophosphamide
    • Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone
    • Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone
    • Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone
    • Drug: Rituximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yi-Jin Gao, MD 86-21-38626161 ext 82064 gaoyijin@scmc.com.cn
Contact: Jing-Yan Tang, MD tangjingyan@scmc.com.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02405676
Other Study ID Numbers  ICMJE CCCG-BNHL-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yi-Jin Gao, Children's Cancer Group, China
Study Sponsor  ICMJE Children's Cancer Group, China
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Yi-Jin Gao, MD Shanghai Children's Medical Center
PRS Account Children's Cancer Group, China
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP