Trial | NCT02405676  Report issue

Title

BNHL-2015 for Children or Adolescents in China
Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    200
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.
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 Started
Jan 31
2015
Primary Completion
Dec 31
2022
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Mar 18
2022

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, 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

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;

Risk group 1 Other

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

Risk group2 Other

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

Risk group3 Other

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.

Risk group4 Other

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.

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.
No Results Posted