Mature B-cell Non-Hodgkin Lymphoma
Conditions
Keywords
Lymphoma, non-Hodgkin, B-lymphocytes, Child, Multicenter study
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.
Interventions
Prednisone 45mg/m2, D1\~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
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;
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;
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;
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;
DRUGRituximab
375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;
Sponsors
Children's Cancer Group, China
Tongji Hospital
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
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival | 2 year |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5 year |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYi-Jin Gao, MD
Shanghai Children's Medical Center
Outcome results
None listed