NCT06573645

A Phase III Clinical Trial of High-dose Rituximab (500mg/m²) Combined With CHOP Regimen in the Treatment of Male Patient With Newly Diagnosed Advanced DLBCL

A Phase III Randomized Controlled Study Comparing High-dose Rituximab (500 mg/m²) Combined With CHOP Regimen Versus Standard-dose Rituximab (375 mg/m²) Combined With CHOP Regimen in Male Patients With Newly Diagnosed Advanced Diffuse Large B-cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Xia Yi · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Comparison of MODIFIED progression-free survival (Modified-PFS) in high-dose rituximab (500mg/m²) 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 (500mg/m²) 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 1:1 ratio to either the experimental group (rituximab 500 mg/m2) or the control group (rituximab 375 mg/m2) 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).

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	Rituximab	Patients will be randomized to receive either rituximab 500 mg/m2 or rituximab 375 mg/m2 for six cycles of R-CHOP (21 days per cycle), followed by two maintenance cycles of rituximab (21 days per cycle).

Timeline

• Start date: 2024-08-23
• Primary completion: 2027-01-12
• Completion: 2027-07-12
• First posted: 2024-08-27
• Last updated: 2024-08-27