Ignite Creation Date:
2024-05-06 @ 3:54 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02405676
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2015-02-26
Brief Title:
BNHL-2015 for Children or Adolescents in China
Sponsor:
Childrens Cancer Group China
Organization:
Childrens Cancer Group China
Study Overview
Official Title:
Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BNHL-2015
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 913 61 for Stage II 758 44 for Stage III 563 135 for Stage IV and 364 145 for B-AL respectively To improve survival for pediatric patients with B-NHLB-AL the investigators launched a new study in China Compared with our previous treatment regimens CCCG-2010 patients with stage III and LDH4 times NL any stage IV or B-AL were stratified into R4 The dose of methotrexate was increased to 5000mgm2 for patients in R3 or R4 previously 3000mgm2 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 5000mgm2 would improving 2-year EFS for patients in advanced groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None