Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573645
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
A Phase III Clinical Trial of High-dose Rituximab 500mgm² Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase III Randomized Controlled Study Comparing High-dose Rituximab 500 mgm² Combined With CHOP Regimen Versus Standard-dose Rituximab 375 mgm² Combined With CHOP Regimen in Male Patients With Newly Diagnosed Advanced Diffuse Large B-cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of MODIFIED progression-free survival Modified-PFS in high-dose rituximab 500mgm² plus CHOP versus standard-dose rituximab plus CHOP in previously untreated TN stage III-IV male DLBCL patients
Detailed Description:
This study is a multicenter randomized controlled Phase III clinical trial that primarily evaluates the modified progression-free survival MODIFIED-PFS in previously untreated male DLBCL patients treated with high-dose rituximab 500mgm² combined with the CHOP regimen compared to standard-dose rituximab combined with the CHOP regimen After signing the informed consent and before randomization all participants must provide sufficient tumor tissue biopsy samples for confirmation of DLBCL via central laboratory tests such as HE staining and IHC Eligible participants are randomized in a 11 ratio to either the experimental group rituximab 500 mgm2 or the control group rituximab 375 mgm2 and will receive 6 cycles of R-CHOP treatment 21 days per cycle followed by 2 additional cycles of maintenance therapy with rituximab 21 days per cycle
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